Trial Outcomes & Findings for Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension (NCT NCT01963208)
NCT ID: NCT01963208
Last Updated: 2023-02-14
Results Overview
Seizure frequency was based on the number of seizures per 28 days, calculated as the number of seizures over the time interval multiplied by 28 and divided by the number of days in the interval. Baseline 28-day seizure frequency was calculated as the number of seizures in the Baseline period (≤ 56 days) divided by the number of days with available seizure data in the Baseline period and multiplied by 28. Baseline was defined as non-missing value of last assessment before first dose. Primary analysis was performed using a rank analysis of covariance (ANCOVA).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
405 participants
Primary outcome timeframe
Baseline and Week 14
Results posted on
2023-02-14
Participant Flow
This was a 2-cohort study where each cohort comprised of 2 treatment phases. Phase 1 was a double-blind phase followed by Phase 2, an open-label phase. The study analyzed safety, tolerability and pharmacokinetics (PK) of Ganaxolone when compared with placebo in both the cohorts.
A total of 405 participants were enrolled in the study. Double Blind: Cohort 1 comprised of Titration period (Week 0 to Week 1) and Maintenance period (Week 1 to Week 9). Double Blind: Cohort 2 comprised of Titration period (Week 0 to Week 2) and Maintenance period (Week 2 to Week 14).
Participant milestones
| Measure |
Double Blind: Cohort 1 - Ganaxolone
Participants were administered ganaxolone 1200 milligrams per day (mg/day) and 1800 mg/day + Antiepileptic drug (AED). Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 1 - Placebo
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Ganaxolone
Participants were administered Ganaxolone 1800 mg/day + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Placebo
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Open Label: Ganaxolone in Double-blind Phase
Following the completion of the double-blind phase, participants randomized to ganaxolone remained on the drug at 1800 mg/day + AED. Participants from Double Blind: Cohort 1 - Ganaxolone and Double Blind: Cohort 2 - Ganaxolone were combined to enter in Open Label: Ganaxolone in Double-blind Phase
|
Open Label: Placebo in Double-blind Phase
Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone + AED. Participants from Double Blind: Cohort 1 - Placebo and Double Blind: Cohort 2 - Placebo were combined to enter in Open Label: Placebo in Double-blind Phase
|
|---|---|---|---|---|---|---|
|
Treatment Phase 1 (Up to Week 14)
STARTED
|
24
|
22
|
179
|
180
|
0
|
0
|
|
Treatment Phase 1 (Up to Week 14)
COMPLETED
|
23
|
19
|
135
|
154
|
0
|
0
|
|
Treatment Phase 1 (Up to Week 14)
NOT COMPLETED
|
1
|
3
|
44
|
26
|
0
|
0
|
|
Treatment Phase 2 (Up to Week 68)
STARTED
|
0
|
0
|
0
|
0
|
158
|
173
|
|
Treatment Phase 2 (Up to Week 68)
COMPLETED
|
0
|
0
|
0
|
0
|
57
|
44
|
|
Treatment Phase 2 (Up to Week 68)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
101
|
129
|
Reasons for withdrawal
| Measure |
Double Blind: Cohort 1 - Ganaxolone
Participants were administered ganaxolone 1200 milligrams per day (mg/day) and 1800 mg/day + Antiepileptic drug (AED). Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 1 - Placebo
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Ganaxolone
Participants were administered Ganaxolone 1800 mg/day + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Placebo
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Open Label: Ganaxolone in Double-blind Phase
Following the completion of the double-blind phase, participants randomized to ganaxolone remained on the drug at 1800 mg/day + AED. Participants from Double Blind: Cohort 1 - Ganaxolone and Double Blind: Cohort 2 - Ganaxolone were combined to enter in Open Label: Ganaxolone in Double-blind Phase
|
Open Label: Placebo in Double-blind Phase
Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone + AED. Participants from Double Blind: Cohort 1 - Placebo and Double Blind: Cohort 2 - Placebo were combined to enter in Open Label: Placebo in Double-blind Phase
|
|---|---|---|---|---|---|---|
|
Treatment Phase 1 (Up to Week 14)
Adverse Event
|
1
|
0
|
30
|
11
|
0
|
0
|
|
Treatment Phase 1 (Up to Week 14)
Withdrawal by Subject
|
0
|
2
|
8
|
9
|
0
|
0
|
|
Treatment Phase 1 (Up to Week 14)
Non-compliance
|
0
|
0
|
4
|
0
|
0
|
0
|
|
Treatment Phase 1 (Up to Week 14)
Protocol Violation
|
0
|
0
|
1
|
3
|
0
|
0
|
|
Treatment Phase 1 (Up to Week 14)
Other
|
0
|
1
|
1
|
1
|
0
|
0
|
|
Treatment Phase 1 (Up to Week 14)
Insufficient Clinical Response
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Phase 1 (Up to Week 14)
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Phase 2 (Up to Week 68)
Adverse Event
|
0
|
0
|
0
|
0
|
16
|
15
|
|
Treatment Phase 2 (Up to Week 68)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
7
|
19
|
|
Treatment Phase 2 (Up to Week 68)
Non-Compliance
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Phase 2 (Up to Week 68)
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Phase 2 (Up to Week 68)
Other
|
0
|
0
|
0
|
0
|
58
|
75
|
|
Treatment Phase 2 (Up to Week 68)
Insufficient Clinical Response
|
0
|
0
|
0
|
0
|
20
|
17
|
|
Treatment Phase 2 (Up to Week 68)
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension
Baseline characteristics by cohort
| Measure |
Double Blind: Cohort 1 - Ganaxolone
n=24 Participants
Participants were administered ganaxolone 1200 mg/day and 1800 mg/day + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 1 - Placebo
n=21 Participants
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Ganaxolone
n=178 Participants
Participants were administered Ganaxolone 1800 mg/day + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Placebo
n=172 Participants
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Total
n=395 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.1 Years
STANDARD_DEVIATION 10.25 • n=39 Participants
|
41.1 Years
STANDARD_DEVIATION 11.83 • n=41 Participants
|
40.6 Years
STANDARD_DEVIATION 12.48 • n=35 Participants
|
42.1 Years
STANDARD_DEVIATION 12.37 • n=31 Participants
|
39.72 Years
STANDARD_DEVIATION 11.73 • n=146 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
113 Participants
n=35 Participants
|
97 Participants
n=31 Participants
|
235 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
65 Participants
n=35 Participants
|
75 Participants
n=31 Participants
|
160 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
11 Participants
n=31 Participants
|
26 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
167 Participants
n=35 Participants
|
161 Participants
n=31 Participants
|
369 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
7 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
8 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
167 Participants
n=35 Participants
|
160 Participants
n=31 Participants
|
368 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
11 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 14Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
Seizure frequency was based on the number of seizures per 28 days, calculated as the number of seizures over the time interval multiplied by 28 and divided by the number of days in the interval. Baseline 28-day seizure frequency was calculated as the number of seizures in the Baseline period (≤ 56 days) divided by the number of days with available seizure data in the Baseline period and multiplied by 28. Baseline was defined as non-missing value of last assessment before first dose. Primary analysis was performed using a rank analysis of covariance (ANCOVA).
Outcome measures
| Measure |
Double Blind: Cohort 2 - Ganaxolone
n=178 Participants
Participants were administered Ganaxolone 1800 mg/day + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Placebo
n=172 Participants
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
|---|---|---|
|
Double Blind: Cohort 2: Percent Change From Baseline in 28-day Seizure Frequency During Titration + Maintenance Period
|
-21.28 Percent change
Interval -29.6 to -14.29
|
-10.25 Percent change
Interval -20.14 to -1.28
|
SECONDARY outcome
Timeframe: Up to Week 14Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
A 50% responder was a participant who experienced at least a 50% decrease in 28-day seizure frequency compared to Baseline.
Outcome measures
| Measure |
Double Blind: Cohort 2 - Ganaxolone
n=178 Participants
Participants were administered Ganaxolone 1800 mg/day + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Placebo
n=172 Participants
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
|---|---|---|
|
Double Blind: Cohort 2: Number of Participants With ≥50% Responder Rate During Titration + Maintenance Period
|
50 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 14Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
Baseline number of seizure free days per 28-day period was calculated as: the number of seizure free days in the entire Baseline period (\<=56 days) divided by the number of days with available seizure data in the baseline period and multiplied by 28. Post-Baseline number of seizure free days per 28-day period was calculated as: the number of seizure free days in the entire treatment period divided by the number of days with available seizure data in the treatment period and multiplied by 28. Change from Baseline in number of seizure free days per 28-day period from Baseline was calculated as: Post-Baseline number of seizure free days per 28-day period minus Baseline number of seizure free days per 28-day period. Baseline was defined as non-missing value of last assessment before first dose.
Outcome measures
| Measure |
Double Blind: Cohort 2 - Ganaxolone
n=178 Participants
Participants were administered Ganaxolone 1800 mg/day + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Placebo
n=172 Participants
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
|---|---|---|
|
Double Blind: Cohort 2: Change From Baseline in the Number of Seizure Free Days Per 28-day Period During Titration + Maintenance Period
|
1.47 Seizure free days
Standard Deviation 4.396
|
1.01 Seizure free days
Standard Deviation 4.223
|
SECONDARY outcome
Timeframe: At Week 14Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
The CGI-I scale is a clinician-rated 7-point Likert scale used to assess the degree to which the participant's epilepsy symptoms have changed relative to Baseline. It was rated as 1. "very much improved"; 2. "much improved"; 3. "minimally improved"; 4. "no change"; 5. "minimally worse"; 6. "much worse"; 7. "very much worse". Higher scores indicated worse condition. Baseline was defined as non-missing value of last assessment before first dose.
Outcome measures
| Measure |
Double Blind: Cohort 2 - Ganaxolone
n=140 Participants
Participants were administered Ganaxolone 1800 mg/day + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Placebo
n=159 Participants
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
|---|---|---|
|
Double Blind: Cohort 2: Number of Participants With Clinical Global Impression of Change - Improvement (CGI-I) at Week 14
Very much improved
|
7 Participants
|
5 Participants
|
|
Double Blind: Cohort 2: Number of Participants With Clinical Global Impression of Change - Improvement (CGI-I) at Week 14
Much improved
|
28 Participants
|
30 Participants
|
|
Double Blind: Cohort 2: Number of Participants With Clinical Global Impression of Change - Improvement (CGI-I) at Week 14
Minimally improved
|
41 Participants
|
47 Participants
|
|
Double Blind: Cohort 2: Number of Participants With Clinical Global Impression of Change - Improvement (CGI-I) at Week 14
No change
|
56 Participants
|
67 Participants
|
|
Double Blind: Cohort 2: Number of Participants With Clinical Global Impression of Change - Improvement (CGI-I) at Week 14
Minimally worse
|
6 Participants
|
8 Participants
|
|
Double Blind: Cohort 2: Number of Participants With Clinical Global Impression of Change - Improvement (CGI-I) at Week 14
Much worse
|
2 Participants
|
2 Participants
|
|
Double Blind: Cohort 2: Number of Participants With Clinical Global Impression of Change - Improvement (CGI-I) at Week 14
Very much worse
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 2 to Week 14Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
Seizure frequency was based on the number of seizures per 28 days, calculated as the number of seizures over the time interval multiplied by 28 and divided by the number of days in the interval. Baseline 28-day seizure frequency was calculated as the number of seizures in the Baseline period (≤ 56 days) divided by the number of days with available seizure data in the Baseline period and multiplied by 28. Baseline was defined as non-missing value of last assessment before first dose.
Outcome measures
| Measure |
Double Blind: Cohort 2 - Ganaxolone
n=166 Participants
Participants were administered Ganaxolone 1800 mg/day + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Placebo
n=169 Participants
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
|---|---|---|
|
Double Blind: Cohort 2: Percent Change From Baseline in 28-day Seizure Frequency During Maintenance Period
|
-20.56 Percent change
Interval -31.56 to -12.69
|
-12.50 Percent change
Interval -20.78 to -3.03
|
SECONDARY outcome
Timeframe: Baseline and Week 14Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
Seizure frequency was based on the number of seizures per 28 days, calculated as the number of seizures over the time interval multiplied by 28 and divided by the number of days in the interval. Baseline 28-day seizure frequency was calculated as the number of seizures in the Baseline period (≤ 56 days) divided by the number of days with available seizure data in the Baseline period and multiplied by 28. Baseline was defined as non-missing value of last assessment before first dose. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Double Blind: Cohort 2 - Ganaxolone
n=178 Participants
Participants were administered Ganaxolone 1800 mg/day + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Placebo
n=172 Participants
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
|---|---|---|
|
Double Blind: Cohort 2: Change From Baseline in 28-day Seizure Frequency During Titration + Maintenance Period
|
-1.46 Seizures per 28 days
Standard Deviation 9.650
|
-0.33 Seizures per 28 days
Standard Deviation 11.040
|
SECONDARY outcome
Timeframe: Baseline and Week 2 to Week 14Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
Seizure frequency was based on the number of seizures per 28 days, calculated as the number of seizures over the time interval multiplied by 28 and divided by the number of days in the interval. Baseline 28-day seizure frequency was calculated as the number of seizures in the Baseline period (≤ 56 days) divided by the number of days with available seizure data in the Baseline period and multiplied by 28. Baseline was defined as non-missing value of last assessment before first dose. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Outcome measures
| Measure |
Double Blind: Cohort 2 - Ganaxolone
n=166 Participants
Participants were administered Ganaxolone 1800 mg/day + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Placebo
n=169 Participants
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
|---|---|---|
|
Double Blind: Cohort 2: Change From Baseline in 28-day Seizure Frequency During Maintenance Period
|
-1.67 Seizures per 28 days
Standard Deviation 11.809
|
-0.64 Seizures per 28 days
Standard Deviation 12.153
|
SECONDARY outcome
Timeframe: Baseline and Week 2 to Week 14Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
Baseline number of seizure free days per 28-day period was calculated as: the number of seizure free days in the entire Baseline period (≤ 56 days) divided by the number of days with available seizure data in the Baseline period and multiplied by 28. Post-Baseline number of seizure free days per 28-day period was calculated as: the number of seizure free days in the entire treatment period divided by the number of days with available seizure data in the treatment period and multiplied by 28. Change from Baseline in number of seizure free days per 28-day period from Baseline was calculated as: Post-Baseline number of seizure free days per 28-day period minus Baseline number of seizure free days per 28-day period. Baseline was defined as non-missing value of last assessment before first dose.
Outcome measures
| Measure |
Double Blind: Cohort 2 - Ganaxolone
n=166 Participants
Participants were administered Ganaxolone 1800 mg/day + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Placebo
n=169 Participants
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
|---|---|---|
|
Double Blind: Cohort 2: Change From Baseline in the Number of Seizure Free Days Per 28-day Period During Maintenance Period
|
1.63 Seizure free days
Standard Deviation 4.824
|
1.20 Seizure free days
Standard Deviation 4.462
|
SECONDARY outcome
Timeframe: Up to Week 14Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
Percentage of participants who had reductions of ≥ 80%, ≥ 60%, ≥ 40%, and ≥ 20% in 28-day seizure frequency from Baseline is presented. A responder is an individual whose reduction of percent change from Baseline in 28-day seizure frequency was ≥ 50%. Baseline was defined as non-missing value of last assessment before first dose.
Outcome measures
| Measure |
Double Blind: Cohort 2 - Ganaxolone
n=178 Participants
Participants were administered Ganaxolone 1800 mg/day + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Placebo
n=172 Participants
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
|---|---|---|
|
Double Blind: Cohort 2: Percentage of Responders Experiencing a ≥R% (80%, 60%, 40%, and 20%) Reduction From Baseline to the End of Treatment Period in 28-day Seizure Frequency During Titration + Maintenance Period
Reduction ≥ 80%
|
7.3 Percentage of participants
|
2.33 Percentage of participants
|
|
Double Blind: Cohort 2: Percentage of Responders Experiencing a ≥R% (80%, 60%, 40%, and 20%) Reduction From Baseline to the End of Treatment Period in 28-day Seizure Frequency During Titration + Maintenance Period
Reduction ≥ 60%
|
20.79 Percentage of participants
|
16.86 Percentage of participants
|
|
Double Blind: Cohort 2: Percentage of Responders Experiencing a ≥R% (80%, 60%, 40%, and 20%) Reduction From Baseline to the End of Treatment Period in 28-day Seizure Frequency During Titration + Maintenance Period
Reduction ≥ 40%
|
33.15 Percentage of participants
|
29.65 Percentage of participants
|
|
Double Blind: Cohort 2: Percentage of Responders Experiencing a ≥R% (80%, 60%, 40%, and 20%) Reduction From Baseline to the End of Treatment Period in 28-day Seizure Frequency During Titration + Maintenance Period
Reduction ≥ 20%
|
51.69 Percentage of participants
|
43.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 2 to Week 14Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
Percentage of participants who had reductions of ≥ 80%, ≥ 60%, ≥ 40%, and ≥ 20% in 28-day seizure frequency from Baseline is presented. A responder is an individual whose reduction of percent change from Baseline in 28-day seizure frequency was ≥ 50%. Baseline was defined as non-missing value of last assessment before first dose.
Outcome measures
| Measure |
Double Blind: Cohort 2 - Ganaxolone
n=178 Participants
Participants were administered Ganaxolone 1800 mg/day + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Placebo
n=172 Participants
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
|---|---|---|
|
Double Blind: Cohort 2: Percentage of Responders Experiencing a ≥R% (80%, 60%, 40%, and 20%) Reduction From Baseline to the End of Treatment Period in 28-day Seizure Frequency During Maintenance Period
Reduction ≥ 20%
|
47.19 Percentage of participants
|
42.44 Percentage of participants
|
|
Double Blind: Cohort 2: Percentage of Responders Experiencing a ≥R% (80%, 60%, 40%, and 20%) Reduction From Baseline to the End of Treatment Period in 28-day Seizure Frequency During Maintenance Period
Reduction ≥ 80%
|
8.43 Percentage of participants
|
5.81 Percentage of participants
|
|
Double Blind: Cohort 2: Percentage of Responders Experiencing a ≥R% (80%, 60%, 40%, and 20%) Reduction From Baseline to the End of Treatment Period in 28-day Seizure Frequency During Maintenance Period
Reduction ≥ 60%
|
24.16 Percentage of participants
|
18.02 Percentage of participants
|
|
Double Blind: Cohort 2: Percentage of Responders Experiencing a ≥R% (80%, 60%, 40%, and 20%) Reduction From Baseline to the End of Treatment Period in 28-day Seizure Frequency During Maintenance Period
Reduction ≥ 40%
|
33.71 Percentage of participants
|
31.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 2 to Week 14Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
Percentage of participants who completed the study without any seizures is presented
Outcome measures
| Measure |
Double Blind: Cohort 2 - Ganaxolone
n=178 Participants
Participants were administered Ganaxolone 1800 mg/day + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Placebo
n=172 Participants
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
|---|---|---|
|
Double Blind: Cohort 2: Percentage of Seizure Free Participants During the Maintenance Period
|
1.12 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 14Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
Percentage of participants who experienced at least one 28-day seizure free period is presented
Outcome measures
| Measure |
Double Blind: Cohort 2 - Ganaxolone
n=178 Participants
Participants were administered Ganaxolone 1800 mg/day + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Placebo
n=172 Participants
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
|---|---|---|
|
Double Blind: Cohort 2: Percentage of Participants Who Experienced at Least One 28-day Seizure Free Period During Titration + Maintenance Phase
|
17.98 Percentage of participants
|
18.02 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 14Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
The longest period of time seizure-free was defined as the percent of the longest seizure-free period (days) divided by the days with available seizure data, and then multiplied by 100%.
Outcome measures
| Measure |
Double Blind: Cohort 2 - Ganaxolone
n=178 Participants
Participants were administered Ganaxolone 1800 mg/day + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Placebo
n=172 Participants
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
|---|---|---|
|
Double Blind: Cohort 2: Longest Percent of Time Spent Seizure-free During Titration + Maintenance Period
|
24.00 Percentage of time spent
Standard Deviation 22.457
|
17.58 Percentage of time spent
Standard Deviation 12.743
|
SECONDARY outcome
Timeframe: Baseline and Week 14Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
Seizure frequency was based on the number of seizures per 28 days, calculated as the number of seizures over the time interval multiplied by 28 and divided by the number of days in the interval. The analysis was conducted for Partial-Onset Seizure (POS) only which included seizure subtypes: Complex partial seizures (CPS), secondarily generalized tonic-clonic (SGTC) seizures, simple partial seizure with motor/observable component (SPS-Motor) and Simple partial seizure (SPS) without motor/observable component. Baseline 28-day seizure frequency was calculated as the number of seizures in the Baseline period (≤ 56 days) divided by the number of days with available seizure data in the Baseline period and multiplied by 28. Baseline was defined as non-missing value of last assessment before first dose.
Outcome measures
| Measure |
Double Blind: Cohort 2 - Ganaxolone
n=150 Participants
Participants were administered Ganaxolone 1800 mg/day + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Placebo
n=152 Participants
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
|---|---|---|
|
Double Blind: Cohort 2: Percent Change From Baseline in 28-day Seizure Frequency for Different Subtypes of Seizures During Titration + Maintenance Period
CPS
|
-4.70 Percent change
Standard Deviation 92.373
|
-6.52 Percent change
Standard Deviation 59.126
|
|
Double Blind: Cohort 2: Percent Change From Baseline in 28-day Seizure Frequency for Different Subtypes of Seizures During Titration + Maintenance Period
SGTC
|
-27.42 Percent change
Standard Deviation 69.394
|
1.02 Percent change
Standard Deviation 118.444
|
|
Double Blind: Cohort 2: Percent Change From Baseline in 28-day Seizure Frequency for Different Subtypes of Seizures During Titration + Maintenance Period
SPS-Motor
|
-5.52 Percent change
Standard Deviation 93.228
|
-21.97 Percent change
Standard Deviation 52.473
|
|
Double Blind: Cohort 2: Percent Change From Baseline in 28-day Seizure Frequency for Different Subtypes of Seizures During Titration + Maintenance Period
SPS
|
12.57 Percent change
Standard Deviation 129.979
|
-3.53 Percent change
Standard Deviation 87.071
|
SECONDARY outcome
Timeframe: Week 8 and Week 14Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
The PGI-I scale was a 7-point Likert scale completed by the Patient or Caregiver representing the degree to which the participant's epilepsy symptoms had changed relative to Baseline. It was rated as 1. "very much improved"; 2. "much improved"; 3. "minimally improved"; 4. "no change"; 5. "minimally worse"; 6. "much worse"; 7. "very much worse". Higher score indicated worse condition. Baseline was defined as non-missing value of last assessment before first dose.
Outcome measures
| Measure |
Double Blind: Cohort 2 - Ganaxolone
n=166 Participants
Participants were administered Ganaxolone 1800 mg/day + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Placebo
n=161 Participants
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
|---|---|---|
|
Double Blind: Cohort 2: Number of Participants With Patient Global Impression of Change - Improvement (PGI-I) at Week 8 and Week 14
Week 14: Much Worse
|
3 Participants
|
4 Participants
|
|
Double Blind: Cohort 2: Number of Participants With Patient Global Impression of Change - Improvement (PGI-I) at Week 8 and Week 14
Week 8: Very Much Improved
|
7 Participants
|
5 Participants
|
|
Double Blind: Cohort 2: Number of Participants With Patient Global Impression of Change - Improvement (PGI-I) at Week 8 and Week 14
Week 8: Much Improved
|
30 Participants
|
21 Participants
|
|
Double Blind: Cohort 2: Number of Participants With Patient Global Impression of Change - Improvement (PGI-I) at Week 8 and Week 14
Week 8: Minimally Improved
|
44 Participants
|
51 Participants
|
|
Double Blind: Cohort 2: Number of Participants With Patient Global Impression of Change - Improvement (PGI-I) at Week 8 and Week 14
Week 8: No Change
|
59 Participants
|
65 Participants
|
|
Double Blind: Cohort 2: Number of Participants With Patient Global Impression of Change - Improvement (PGI-I) at Week 8 and Week 14
Week 8: Minimally Worse
|
12 Participants
|
11 Participants
|
|
Double Blind: Cohort 2: Number of Participants With Patient Global Impression of Change - Improvement (PGI-I) at Week 8 and Week 14
Week 8: Much Worse
|
8 Participants
|
4 Participants
|
|
Double Blind: Cohort 2: Number of Participants With Patient Global Impression of Change - Improvement (PGI-I) at Week 8 and Week 14
Week 8: Very Much Worse
|
6 Participants
|
4 Participants
|
|
Double Blind: Cohort 2: Number of Participants With Patient Global Impression of Change - Improvement (PGI-I) at Week 8 and Week 14
Week 14: Very Much Improved
|
7 Participants
|
10 Participants
|
|
Double Blind: Cohort 2: Number of Participants With Patient Global Impression of Change - Improvement (PGI-I) at Week 8 and Week 14
Week 14: Much Improved
|
33 Participants
|
29 Participants
|
|
Double Blind: Cohort 2: Number of Participants With Patient Global Impression of Change - Improvement (PGI-I) at Week 8 and Week 14
Week 14: Minimally Improved
|
43 Participants
|
43 Participants
|
|
Double Blind: Cohort 2: Number of Participants With Patient Global Impression of Change - Improvement (PGI-I) at Week 8 and Week 14
Week 14: No Change
|
46 Participants
|
60 Participants
|
|
Double Blind: Cohort 2: Number of Participants With Patient Global Impression of Change - Improvement (PGI-I) at Week 8 and Week 14
Week 14: Minimally Worse
|
7 Participants
|
12 Participants
|
|
Double Blind: Cohort 2: Number of Participants With Patient Global Impression of Change - Improvement (PGI-I) at Week 8 and Week 14
Week 14: Very Much Worse
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At Week 8Population: mITT Population. Only those participants with data available at the specified data points were analyzed.
The CGI-I scale is a clinician-rated 7-point Likert scale used to assess the degree to which the participant's epilepsy symptoms have changed relative to Baseline. It was rated as 1. "very much improved"; 2. "much improved"; 3. "minimally improved"; 4. "no change"; 5. "minimally worse"; 6. "much worse"; 7. "very much worse". Higher scores indicated worse condition. Baseline was defined as non-missing value of last assessment before first dose.
Outcome measures
| Measure |
Double Blind: Cohort 2 - Ganaxolone
n=166 Participants
Participants were administered Ganaxolone 1800 mg/day + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Placebo
n=162 Participants
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
|---|---|---|
|
Double Blind: Cohort 2: Number of Participants With Clinical Global Impression of Change - Improvement (CGI-I) at Week 8
Very much worse
|
1 Participants
|
1 Participants
|
|
Double Blind: Cohort 2: Number of Participants With Clinical Global Impression of Change - Improvement (CGI-I) at Week 8
Much improved
|
27 Participants
|
20 Participants
|
|
Double Blind: Cohort 2: Number of Participants With Clinical Global Impression of Change - Improvement (CGI-I) at Week 8
Very much improved
|
3 Participants
|
4 Participants
|
|
Double Blind: Cohort 2: Number of Participants With Clinical Global Impression of Change - Improvement (CGI-I) at Week 8
Minimally improved
|
50 Participants
|
49 Participants
|
|
Double Blind: Cohort 2: Number of Participants With Clinical Global Impression of Change - Improvement (CGI-I) at Week 8
No change
|
68 Participants
|
71 Participants
|
|
Double Blind: Cohort 2: Number of Participants With Clinical Global Impression of Change - Improvement (CGI-I) at Week 8
Minimally worse
|
8 Participants
|
12 Participants
|
|
Double Blind: Cohort 2: Number of Participants With Clinical Global Impression of Change - Improvement (CGI-I) at Week 8
Much worse
|
9 Participants
|
5 Participants
|
Adverse Events
Double Blind: Cohort 1 - Ganaxolone
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Double Blind: Cohort 1 - Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Double Blind: Cohort 2 - Ganaxolone
Serious events: 9 serious events
Other events: 91 other events
Deaths: 0 deaths
Double Blind: Cohort 2 - Placebo
Serious events: 9 serious events
Other events: 42 other events
Deaths: 0 deaths
Open Label: Ganaxolone in Double-blind Phase
Serious events: 12 serious events
Other events: 42 other events
Deaths: 0 deaths
Open Label: Placebo in Double-blind Phase
Serious events: 12 serious events
Other events: 67 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Double Blind: Cohort 1 - Ganaxolone
n=24 participants at risk
Participants were administered ganaxolone 1200 mg/day and 1800 mg/day + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 1 - Placebo
n=21 participants at risk
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Ganaxolone
n=179 participants at risk
Participants were administered Ganaxolone 1800 mg/day + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Placebo
n=176 participants at risk
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Open Label: Ganaxolone in Double-blind Phase
n=158 participants at risk
Following the completion of the double-blind phase, participants randomized to ganaxolone remained on the drug at 1800 mg/day + AED. Participants from Double Blind: Cohort 1 - Ganaxolone and Double Blind: Cohort 2 - Ganaxolone were combined to enter in Open Label: Ganaxolone in Double-blind Phase
|
Open Label: Placebo in Double-blind Phase
n=173 participants at risk
Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone + AED. Participants from Double Blind: Cohort 1 - Placebo and Double Blind: Cohort 2 - Placebo were combined to enter in Open Label: Placebo in Double-blind Phase
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.57%
1/176 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.56%
1/179 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.63%
1/158 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.56%
1/179 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
General disorders
Gait disturbance
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.56%
1/179 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.58%
1/173 • Number of events 2 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Asthenia
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.58%
1/173 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.63%
1/158 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.63%
1/158 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.56%
1/179 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.63%
1/158 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.57%
1/176 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.58%
1/173 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.56%
1/179 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.63%
1/158 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.56%
1/179 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.58%
1/173 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.57%
1/176 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.58%
1/173 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.58%
1/173 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.58%
1/173 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.57%
1/176 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.56%
1/179 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.63%
1/158 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.58%
1/173 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.56%
1/179 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
1.1%
2/179 • Number of events 2 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
1.1%
2/176 • Number of events 2 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.63%
1/158 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
2.3%
4/173 • Number of events 4 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.57%
1/176 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.58%
1/173 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.57%
1/176 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.58%
1/173 • Number of events 2 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Seizure cluster
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.63%
1/158 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.56%
1/179 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.63%
1/158 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.63%
1/158 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.63%
1/158 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.63%
1/158 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.58%
1/173 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.56%
1/179 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.58%
1/173 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Delusion
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.58%
1/173 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Depression
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.56%
1/179 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.63%
1/158 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.63%
1/158 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.57%
1/176 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.63%
1/158 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.63%
1/158 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.56%
1/179 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.56%
1/179 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Postictal psychosis
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.57%
1/176 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Psychiatric disorders
Psychogenic seizure
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.57%
1/176 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.56%
1/179 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
Other adverse events
| Measure |
Double Blind: Cohort 1 - Ganaxolone
n=24 participants at risk
Participants were administered ganaxolone 1200 mg/day and 1800 mg/day + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 1 - Placebo
n=21 participants at risk
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Ganaxolone
n=179 participants at risk
Participants were administered Ganaxolone 1800 mg/day + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Double Blind: Cohort 2 - Placebo
n=176 participants at risk
Participants were administered Placebo + AED. Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone while participants randomized to ganaxolone remained on the drug at 1800 mg/day in the open-label phase.
|
Open Label: Ganaxolone in Double-blind Phase
n=158 participants at risk
Following the completion of the double-blind phase, participants randomized to ganaxolone remained on the drug at 1800 mg/day + AED. Participants from Double Blind: Cohort 1 - Ganaxolone and Double Blind: Cohort 2 - Ganaxolone were combined to enter in Open Label: Ganaxolone in Double-blind Phase
|
Open Label: Placebo in Double-blind Phase
n=173 participants at risk
Following the completion of the double-blind phase, participants randomized to placebo were transitioned to ganaxolone + AED. Participants from Double Blind: Cohort 1 - Placebo and Double Blind: Cohort 2 - Placebo were combined to enter in Open Label: Placebo in Double-blind Phase
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Somnolence
|
12.5%
3/24 • Number of events 3 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
9.5%
2/21 • Number of events 2 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
22.3%
40/179 • Number of events 50 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
4.5%
8/176 • Number of events 8 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
7.6%
12/158 • Number of events 13 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
16.8%
29/173 • Number of events 33 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
8.3%
2/24 • Number of events 3 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
19.0%
34/179 • Number of events 44 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
5.1%
9/176 • Number of events 9 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
5.1%
8/158 • Number of events 16 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
15.6%
27/173 • Number of events 29 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
8.3%
2/24 • Number of events 2 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
8.9%
16/179 • Number of events 17 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
8.5%
15/176 • Number of events 15 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
5.7%
9/158 • Number of events 15 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
6.4%
11/173 • Number of events 12 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Balance disorder
|
8.3%
2/24 • Number of events 2 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
2.8%
5/179 • Number of events 5 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.57%
1/176 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
1.9%
3/158 • Number of events 3 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.58%
1/173 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Ataxia
|
12.5%
3/24 • Number of events 4 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
1.7%
3/179 • Number of events 3 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
1.3%
2/158 • Number of events 2 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
1.2%
2/173 • Number of events 3 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Dysarthria
|
8.3%
2/24 • Number of events 2 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.56%
1/179 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.57%
1/176 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
1.3%
2/158 • Number of events 2 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
2.3%
4/173 • Number of events 4 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Nervous system disorders
Sedation
|
12.5%
3/24 • Number of events 3 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.56%
1/179 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.63%
1/158 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.58%
1/173 • Number of events 2 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
2.8%
5/179 • Number of events 5 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
5.1%
9/176 • Number of events 9 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
3.8%
6/158 • Number of events 6 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
5.2%
9/173 • Number of events 9 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
8.3%
2/24 • Number of events 2 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/21 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
11.7%
21/179 • Number of events 28 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
6.8%
12/176 • Number of events 12 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
5.7%
9/158 • Number of events 10 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
8.7%
15/173 • Number of events 19 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
|
General disorders
Night sweats
|
0.00%
0/24 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
4.8%
1/21 • Number of events 1 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/179 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/176 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/158 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
0.00%
0/173 • Week -8 through Week 14 in Double blind phase and from Week 16 to Week 68 in open label phase
Safety Population: included all randomized participants who received at least 1 dose of study medication.
|
Additional Information
Marinus Clinical Trials Submission Manager
Marinus Pharmaceuticals, Inc.
Phone: 484-801-4670
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place