Trial Outcomes & Findings for Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures (NCT NCT00334958)
NCT ID: NCT00334958
Last Updated: 2021-06-14
Results Overview
Seizure data was collected via patient diary, which was used to record daily seizure count and type. Intent-to-treat (ITT) population: All randomized participants who had baseline Patient Seizure Diary data and had at least completed the titration period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
356 participants
Primary outcome timeframe
Baseline, Days 13 to 96
Results posted on
2021-06-14
Participant Flow
Participants were screened at 75 centers (69 in the United States and 6 in Canada). Participants were enrolled at 65 centers (61 in the United States and 4 in Canada).
Participant milestones
| Measure |
Rufinamide
For the 12-day Titration Phase, rufinamide were administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the 12 week Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Participants unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
|
Placebo
For 12-day Titration Phase and 12 week Maintenance Phase, placebo tablets matching to rufinamide 400 mg oral tablets were administered according to the same regimen scheme as described for rufinamide. For 12-day Titration Phase, 1 matching placebo tablet were administered twice daily and increased by 1 tablet every 3 days up to maximum of 4 matching placebo tablets twice daily (placebo tablet matched to rufinamide total daily dose of 3200 mg). For the 12 week maintenance phase, 4 placebo tablets matching to rufinamide maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Similar to the dose reduction permitted in the rufinamide group, participants in placebo group were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily.
|
|---|---|---|
|
Overall Study
STARTED
|
176
|
180
|
|
Overall Study
COMPLETED
|
139
|
156
|
|
Overall Study
NOT COMPLETED
|
37
|
24
|
Reasons for withdrawal
| Measure |
Rufinamide
For the 12-day Titration Phase, rufinamide were administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the 12 week Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Participants unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
|
Placebo
For 12-day Titration Phase and 12 week Maintenance Phase, placebo tablets matching to rufinamide 400 mg oral tablets were administered according to the same regimen scheme as described for rufinamide. For 12-day Titration Phase, 1 matching placebo tablet were administered twice daily and increased by 1 tablet every 3 days up to maximum of 4 matching placebo tablets twice daily (placebo tablet matched to rufinamide total daily dose of 3200 mg). For the 12 week maintenance phase, 4 placebo tablets matching to rufinamide maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Similar to the dose reduction permitted in the rufinamide group, participants in placebo group were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily.
|
|---|---|---|
|
Overall Study
Medication Noncompliance
|
0
|
3
|
|
Overall Study
Protocol Violation
|
2
|
2
|
|
Overall Study
Request of the investigator or sponsor
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
4
|
|
Overall Study
Adverse Event
|
27
|
12
|
|
Overall Study
Other
|
1
|
2
|
Baseline Characteristics
Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures
Baseline characteristics by cohort
| Measure |
Rufinamide
n=176 Participants
For the 12-day Titration Phase, rufinamide were administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the 12 week Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Participants unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
|
Placebo
n=180 Participants
For 12-day Titration Phase and 12 week Maintenance Phase, placebo tablets matching to rufinamide 400 mg oral tablets were administered according to the same regimen scheme as described for rufinamide. For 12-day Titration Phase, 1 matching placebo tablet were administered twice daily and increased by 1 tablet every 3 days up to maximum of 4 matching placebo tablets twice daily (placebo tablet matched to rufinamide total daily dose of 3200 mg). For the 12 week maintenance phase, 4 placebo tablets matching to rufinamide maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Similar to the dose reduction permitted in the rufinamide group, participants in placebo group were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily.
|
Total
n=356 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
12 to < 18 years
|
15 participants
n=99 Participants
|
21 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Age, Customized
18 to <65 years
|
155 participants
n=99 Participants
|
153 participants
n=107 Participants
|
308 participants
n=206 Participants
|
|
Age, Customized
>=65 years
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=99 Participants
|
97 Participants
n=107 Participants
|
189 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
167 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
14 participants
n=99 Participants
|
19 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
145 participants
n=99 Participants
|
140 participants
n=107 Participants
|
285 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
13 participants
n=99 Participants
|
14 participants
n=107 Participants
|
27 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Days 13 to 96Population: Intent-to-treat (ITT) population: All randomized participants who had baseline Patient Seizure Diary data and had at least completed the titration period.
Seizure data was collected via patient diary, which was used to record daily seizure count and type. Intent-to-treat (ITT) population: All randomized participants who had baseline Patient Seizure Diary data and had at least completed the titration period.
Outcome measures
| Measure |
Rufinamide
n=160 Participants
For the 12-day Titration Phase, rufinamide were administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the 12 week Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Participants unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
|
Placebo
n=175 Participants
For 12-day Titration Phase and 12 week Maintenance Phase, placebo tablets matching to rufinamide 400 mg oral tablets were administered according to the same regimen scheme as described for rufinamide. For 12-day Titration Phase, 1 matching placebo tablet were administered twice daily and increased by 1 tablet every 3 days up to maximum of 4 matching placebo tablets twice daily (placebo tablet matched to rufinamide total daily dose of 3200 mg). For the 12 week maintenance phase, 4 placebo tablets matching to rufinamide maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Similar to the dose reduction permitted in the rufinamide group, participants in placebo group were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily.
|
|---|---|---|
|
Percentage Change in Total Partial Seizure Frequency Per 28 Days During Maintenance Phase Relative to the Baseline Phase
|
-23.25 Percentage change
Interval -100.0 to 725.6
|
-9.80 Percentage change
Interval -100.0 to 864.3
|
SECONDARY outcome
Timeframe: Baseline, Days 13 to 96Population: ITT population: All randomized participants who had baseline Patient Seizure Diary data and had at least completed the titration period.
Seizure data was collected via patient diary, which was used to record daily seizure count and type.
Outcome measures
| Measure |
Rufinamide
n=160 Participants
For the 12-day Titration Phase, rufinamide were administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the 12 week Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Participants unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
|
Placebo
n=175 Participants
For 12-day Titration Phase and 12 week Maintenance Phase, placebo tablets matching to rufinamide 400 mg oral tablets were administered according to the same regimen scheme as described for rufinamide. For 12-day Titration Phase, 1 matching placebo tablet were administered twice daily and increased by 1 tablet every 3 days up to maximum of 4 matching placebo tablets twice daily (placebo tablet matched to rufinamide total daily dose of 3200 mg). For the 12 week maintenance phase, 4 placebo tablets matching to rufinamide maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Similar to the dose reduction permitted in the rufinamide group, participants in placebo group were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily.
|
|---|---|---|
|
Percentage of Participants With 50% or Greater Reduction in Total Partial Seizure Frequency Per 28 Days During the Maintenance Phase Relative to the Baseline Phase
|
32.5 Percentage of Participants
|
14.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Days 13 to 96Population: ITT population: All randomized participants who had baseline Patient Seizure Diary data and had at least completed the titration period.
Total partial seizure frequencies per 28 days during the double-blind Maintenance and Baseline Phases were transformed using logarithms to the base 10 (log10), because it was expected from previous studies that the results would not be normally distributed.
Outcome measures
| Measure |
Rufinamide
n=160 Participants
For the 12-day Titration Phase, rufinamide were administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the 12 week Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Participants unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
|
Placebo
n=175 Participants
For 12-day Titration Phase and 12 week Maintenance Phase, placebo tablets matching to rufinamide 400 mg oral tablets were administered according to the same regimen scheme as described for rufinamide. For 12-day Titration Phase, 1 matching placebo tablet were administered twice daily and increased by 1 tablet every 3 days up to maximum of 4 matching placebo tablets twice daily (placebo tablet matched to rufinamide total daily dose of 3200 mg). For the 12 week maintenance phase, 4 placebo tablets matching to rufinamide maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Similar to the dose reduction permitted in the rufinamide group, participants in placebo group were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily.
|
|---|---|---|
|
Log10 Transformed Total Partial Seizure Frequency Per 28 Days During the Baseline Phase and Maintenance Phase
|
0.98 Seizures per 28-days (log-transformed)
Standard Deviation 0.675
|
1.13 Seizures per 28-days (log-transformed)
Standard Deviation 0.520
|
SECONDARY outcome
Timeframe: Baseline, Days 13 to 96Population: ITT population: All randomized participants who had baseline Patient Seizure Diary data and had at least completed the titration period.
RRATIO= 100\*(T-B)/(T+B) where T= total seizure frequency per 28 days during the Maintenance Phase, and B=total seizure frequency per 28 days during the Baseline Phase.
Outcome measures
| Measure |
Rufinamide
n=160 Participants
For the 12-day Titration Phase, rufinamide were administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the 12 week Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Participants unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
|
Placebo
n=175 Participants
For 12-day Titration Phase and 12 week Maintenance Phase, placebo tablets matching to rufinamide 400 mg oral tablets were administered according to the same regimen scheme as described for rufinamide. For 12-day Titration Phase, 1 matching placebo tablet were administered twice daily and increased by 1 tablet every 3 days up to maximum of 4 matching placebo tablets twice daily (placebo tablet matched to rufinamide total daily dose of 3200 mg). For the 12 week maintenance phase, 4 placebo tablets matching to rufinamide maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Similar to the dose reduction permitted in the rufinamide group, participants in placebo group were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily.
|
|---|---|---|
|
Reduction From Baseline in Total Partial Seizure Frequency Rate (RRATIO) During Maintenance Phase
|
-18.76 RRATIO
Standard Deviation 37.841
|
-6.90 RRATIO
Standard Deviation 24.869
|
Adverse Events
Rufinamide
Serious events: 6 serious events
Other events: 101 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rufinamide
n=176 participants at risk
For the 12-day Titration Phase, rufinamide were administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the 12 week Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Participants unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
|
Placebo
n=180 participants at risk
For 12-day Titration Phase and 12 week Maintenance Phase, placebo tablets matching to rufinamide 400 mg oral tablets were administered according to the same regimen scheme as described for rufinamide. For 12-day Titration Phase, 1 matching placebo tablet were administered twice daily and increased by 1 tablet every 3 days up to maximum of 4 matching placebo tablets twice daily (placebo tablet matched to rufinamide total daily dose of 3200 mg). For the 12 week maintenance phase, 4 placebo tablets matching to rufinamide maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Similar to the dose reduction permitted in the rufinamide group, participants in placebo group were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.57%
1/176 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
0.00%
0/180 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
|
Gastrointestinal disorders
Vomiting
|
0.57%
1/176 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
0.00%
0/180 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/176 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
0.56%
1/180 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.00%
0/176 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
0.56%
1/180 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.57%
1/176 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
0.00%
0/180 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
|
Investigations
Weight decreased
|
0.57%
1/176 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
0.00%
0/180 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
|
Nervous system disorders
Complex partial seizures
|
0.57%
1/176 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
0.56%
1/180 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
|
Nervous system disorders
Convulsion
|
1.1%
2/176 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
1.1%
2/180 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
|
Nervous system disorders
Coordination abnormal
|
0.57%
1/176 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
0.00%
0/180 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
|
Nervous system disorders
Lethargy
|
0.57%
1/176 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
0.00%
0/180 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.57%
1/176 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
0.00%
0/180 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/176 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
0.56%
1/180 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.00%
0/176 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
0.56%
1/180 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.57%
1/176 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
0.00%
0/180 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/176 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
0.56%
1/180 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
Other adverse events
| Measure |
Rufinamide
n=176 participants at risk
For the 12-day Titration Phase, rufinamide were administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the 12 week Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Participants unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
|
Placebo
n=180 participants at risk
For 12-day Titration Phase and 12 week Maintenance Phase, placebo tablets matching to rufinamide 400 mg oral tablets were administered according to the same regimen scheme as described for rufinamide. For 12-day Titration Phase, 1 matching placebo tablet were administered twice daily and increased by 1 tablet every 3 days up to maximum of 4 matching placebo tablets twice daily (placebo tablet matched to rufinamide total daily dose of 3200 mg). For the 12 week maintenance phase, 4 placebo tablets matching to rufinamide maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Similar to the dose reduction permitted in the rufinamide group, participants in placebo group were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily.
|
|---|---|---|
|
Eye disorders
Diplopia
|
8.0%
14/176 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
1.1%
2/180 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
22/176 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
5.0%
9/180 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
13/176 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
5.0%
9/180 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
|
General disorders
Fatigue
|
15.3%
27/176 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
10.0%
18/180 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
6/176 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
8.3%
15/180 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.1%
9/176 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
2.8%
5/180 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
|
Nervous system disorders
Dizziness
|
26.7%
47/176 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
8.3%
15/180 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
|
Nervous system disorders
Headache
|
16.5%
29/176 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
12.8%
23/180 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
|
Nervous system disorders
Somnolence
|
12.5%
22/176 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
7.2%
13/180 • All AEs were collected throughout the study from the time of consent to follow-up visit or 30 days after study drug discontinuation, whichever was longer (up to approximately 3 years and 3 months)
Serious adverse events (SAEs), regardless of causality assessment, were collected through the follow-up visit or 30 days after study drug discontinuation, whichever was longer.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place