Trial Outcomes & Findings for A Study to Evaluate Efficacy, Safety, and Tolerability of Darigabat in Participants With Panic Disorder (NCT NCT05941442)
NCT ID: NCT05941442
Last Updated: 2026-05-07
Results Overview
Numerator is the number of participants in the period who were panic free and had no fewer that 12 eDiary entries. Denominator is the number of participants in the period who were panic free and had no fewer than 12 eDiary entries in the corresponding time period plus anyone who had an eDiary entry and reported a panic attack in the corresponding time period, regardless of number of eDiary entries.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
Week 13-14
Results posted on
2026-05-07
Participant Flow
The Sponsor terminated the study due to significant enrollment and study design challenges.
Participant milestones
| Measure |
Placebo
Participants received darigabat matching placebo, orally, BID for 2 weeks during the Titration Period and thereafter for 12 weeks during the Maintenance Treatment Period.
|
Darigabat 25 mg BID
Participants received darigabat, up to a maximum dose of 12.5 mg, orally, BID, for 2 weeks during the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks during the Maintenance Treatment Period.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
26
|
30
|
|
Overall Study
NOT COMPLETED
|
14
|
10
|
Reasons for withdrawal
| Measure |
Placebo
Participants received darigabat matching placebo, orally, BID for 2 weeks during the Titration Period and thereafter for 12 weeks during the Maintenance Treatment Period.
|
Darigabat 25 mg BID
Participants received darigabat, up to a maximum dose of 12.5 mg, orally, BID, for 2 weeks during the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks during the Maintenance Treatment Period.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
|
Overall Study
Non-Compliance with Study Drug
|
0
|
1
|
|
Overall Study
Site Terminated by Sponsor
|
1
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Not disclosed
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate Efficacy, Safety, and Tolerability of Darigabat in Participants With Panic Disorder
Baseline characteristics by cohort
| Measure |
Placebo
n=40 Participants
Participants received darigabat matching placebo, orally, BID for 2 weeks during the Titration Period and thereafter for 12 weeks during the Maintenance Treatment Period.
|
Darigabat 25 mg BID
n=40 Participants
Participants received darigabat, up to a maximum dose of 12.5 mg, orally, BID, for 2 weeks during the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks during the Maintenance Treatment Period.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.5 years
STANDARD_DEVIATION 13.40 • n=54 Participants
|
42.3 years
STANDARD_DEVIATION 13.96 • n=60 Participants
|
42.9 years
STANDARD_DEVIATION 13.61 • n=114 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=54 Participants
|
29 Participants
n=60 Participants
|
61 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=54 Participants
|
11 Participants
n=60 Participants
|
19 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=54 Participants
|
17 Participants
n=60 Participants
|
34 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=54 Participants
|
23 Participants
n=60 Participants
|
46 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=54 Participants
|
7 Participants
n=60 Participants
|
11 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=54 Participants
|
32 Participants
n=60 Participants
|
67 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: Week 13-14Population: Full Analysis Set: Panic Attack Endpoints
Numerator is the number of participants in the period who were panic free and had no fewer that 12 eDiary entries. Denominator is the number of participants in the period who were panic free and had no fewer than 12 eDiary entries in the corresponding time period plus anyone who had an eDiary entry and reported a panic attack in the corresponding time period, regardless of number of eDiary entries.
Outcome measures
| Measure |
Placebo
n=25 Participants
Participants received darigabat matching placebo, orally, BID for 2 weeks during the Titration Period and thereafter for 12 weeks during the Maintenance Treatment Period.
|
Darigabat 25 mg BID
n=19 Participants
Participants received darigabat, up to a maximum dose of 12.5 mg, orally, BID, for 2 weeks during the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks during the Maintenance Treatment Period.
|
|---|---|---|
|
Percentage of Participants Free of Panic Attacks as Assessed by Participant Daily eDiary During the Last Two Weeks of the Maintenance Treatment Period
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 14 (Day 98)Population: Full Analysis Set: Expanded
The Panic Disorder Severity Scale (PDSS) is a 7-item scale, with each item rated on a 5-point scale (0-4), allowing a total of 0-28 where higher score reflects greater disease severity.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants received darigabat matching placebo, orally, BID for 2 weeks during the Titration Period and thereafter for 12 weeks during the Maintenance Treatment Period.
|
Darigabat 25 mg BID
n=34 Participants
Participants received darigabat, up to a maximum dose of 12.5 mg, orally, BID, for 2 weeks during the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks during the Maintenance Treatment Period.
|
|---|---|---|
|
Change From Baseline in the Panic Disorder Severity Scale (PDSS) Total Score at Week 14
|
-9.3 units on a scale
Standard Error 2.71
|
-11.4 units on a scale
Standard Error 2.59
|
SECONDARY outcome
Timeframe: Week 13-14Population: Full Analysis Set: Panic Attack Endpoints
Panic attack frequency is defined as the total number of panic attacks over each two-week interval divided by the total number of days the eDiary was completed in the same analysis period multiplied by 14. Participants with a minimum of 7 completed diary days in a two-week interval will be considered for panic attack frequency, otherwise will be considered missing.
Outcome measures
| Measure |
Placebo
n=26 Participants
Participants received darigabat matching placebo, orally, BID for 2 weeks during the Titration Period and thereafter for 12 weeks during the Maintenance Treatment Period.
|
Darigabat 25 mg BID
n=25 Participants
Participants received darigabat, up to a maximum dose of 12.5 mg, orally, BID, for 2 weeks during the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks during the Maintenance Treatment Period.
|
|---|---|---|
|
Change From Baseline in Panic Attack Frequency During the Last Two Weeks of the Maintenance Treatment Period
|
-5.29 number of panic attacks/14 days
Standard Deviation 3.383
|
-5.30 number of panic attacks/14 days
Standard Deviation 4.973
|
SECONDARY outcome
Timeframe: Baseline through Week 14 (2 Weeks Titration and 12 Weeks Maintenance Treatment)Population: Full Analysis Set: Panic Attack Endpoints Odds ratio and confidence intervals were not estimable (NE) because the model estimates were unattainable due to sparseness of the data.
Numerator is the number of participants who were panic free and had no fewer than 12 eDiary entries in the corresponding time period. Denominator is the number of participants in the period who were panic free and had no fewer than 12 eDiary entries in the corresponding time period plus anyone who had an eDiary entry and reported a panic attack in the corresponding time period, regardless of number of eDiary entries. \* Last Two Weeks of Maintenance Treatment Prior to Subject's Completion/Early Termination = Includes assessments made in the last two weeks of the Maintenance Period prior to completion/early termination for all subjects that had at least 2 weeks of data in the maintenance period, which would be Maintenance Week 11-12 for subjects who completed and earlier for subjects who terminated study participation prior to completion.
Outcome measures
| Measure |
Placebo
n=30 Participants
Participants received darigabat matching placebo, orally, BID for 2 weeks during the Titration Period and thereafter for 12 weeks during the Maintenance Treatment Period.
|
Darigabat 25 mg BID
n=29 Participants
Participants received darigabat, up to a maximum dose of 12.5 mg, orally, BID, for 2 weeks during the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks during the Maintenance Treatment Period.
|
|---|---|---|
|
Change From Baseline in the Proportion of Participants Free of Panic Attacks as Assessed by Participant Daily Diary by Two-Week Intervals
Titration Period (2 Weeks)
|
3 Participants
|
6 Participants
|
|
Change From Baseline in the Proportion of Participants Free of Panic Attacks as Assessed by Participant Daily Diary by Two-Week Intervals
Maintenance Week 1-2
|
3 Participants
|
3 Participants
|
|
Change From Baseline in the Proportion of Participants Free of Panic Attacks as Assessed by Participant Daily Diary by Two-Week Intervals
Maintenance Week 3-4
|
3 Participants
|
7 Participants
|
|
Change From Baseline in the Proportion of Participants Free of Panic Attacks as Assessed by Participant Daily Diary by Two-Week Intervals
Maintenance Week 5-6
|
5 Participants
|
6 Participants
|
|
Change From Baseline in the Proportion of Participants Free of Panic Attacks as Assessed by Participant Daily Diary by Two-Week Intervals
Maintenance Week 7-8
|
4 Participants
|
4 Participants
|
|
Change From Baseline in the Proportion of Participants Free of Panic Attacks as Assessed by Participant Daily Diary by Two-Week Intervals
Maintenance Week 9-10
|
2 Participants
|
4 Participants
|
|
Change From Baseline in the Proportion of Participants Free of Panic Attacks as Assessed by Participant Daily Diary by Two-Week Intervals
Maintenance Week 11-12
|
2 Participants
|
5 Participants
|
|
Change From Baseline in the Proportion of Participants Free of Panic Attacks as Assessed by Participant Daily Diary by Two-Week Intervals
Last Two Weeks of Maintenance Treatment Prior to Subject's Completion/Early Termination*
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline through Week 14Population: Full Analysis Set: Expanded
The Panic Disorder Severity Scale (PDSS) is a 7-item scale, with each item rated on a 5-point scale (0-4), allowing a total of 0-28 where higher score reflects greater disease severity. Change from baseline = value - baseline value; n = number of participants with a non-missing value; overall N = number of participants in treatment group
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants received darigabat matching placebo, orally, BID for 2 weeks during the Titration Period and thereafter for 12 weeks during the Maintenance Treatment Period.
|
Darigabat 25 mg BID
n=34 Participants
Participants received darigabat, up to a maximum dose of 12.5 mg, orally, BID, for 2 weeks during the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks during the Maintenance Treatment Period.
|
|---|---|---|
|
Change From Baseline at All Time Points up to Week 14 in the PDSS Total Score
Visit 6 (Day 98)
|
-9.3 units on a scale
Standard Error 2.71
|
-11.4 units on a scale
Standard Error 2.59
|
|
Change From Baseline at All Time Points up to Week 14 in the PDSS Total Score
Visit 4 (Day 42)
|
-8.1 units on a scale
Standard Error 2.65
|
-9.0 units on a scale
Standard Error 2.51
|
|
Change From Baseline at All Time Points up to Week 14 in the PDSS Total Score
Visit 5 (Day 70)
|
-8.1 units on a scale
Standard Error 2.72
|
-10.5 units on a scale
Standard Error 2.59
|
SECONDARY outcome
Timeframe: Baseline through Week 14 (2 Weeks Titration and 12 Weeks Maintenance Treatment)Population: Full Analysis Set: Panic Attack Endpoints
Panic attack frequency is defined as the total number of panic attacks over each two-week interval divided by the total number of days the eDiary was completed in the same analysis period multiplied by 14. Participants with a minimum of 7 completed diary days in a two-week interval will be considered for panic attack frequency, otherwise will be considered missing. Change from baseline = value - baseline value; n = number of participants with a non-missing value; overall N = number of participants in treatment group \* Last Two Weeks of Maintenance Treatment Prior to Subject's Completion/Early Termination = Includes assessments made in the last two weeks of the Maintenance Period prior to completion/early termination for all subjects that had at least 2 weeks of data in the maintenance period, which would be Maintenance Week 11-12 for subjects who completed and earlier for subjects who terminated study participation prior to completion.
Outcome measures
| Measure |
Placebo
n=30 Participants
Participants received darigabat matching placebo, orally, BID for 2 weeks during the Titration Period and thereafter for 12 weeks during the Maintenance Treatment Period.
|
Darigabat 25 mg BID
n=29 Participants
Participants received darigabat, up to a maximum dose of 12.5 mg, orally, BID, for 2 weeks during the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks during the Maintenance Treatment Period.
|
|---|---|---|
|
Change From Baseline in Panic Attack Frequency by Two-Week Intervals Through Week 14
Baseline Frequency (Pre-treatment)
|
7.69 number of panic attacks/14 days
Standard Deviation 4.020
|
8.12 number of panic attacks/14 days
Standard Deviation 4.449
|
|
Change From Baseline in Panic Attack Frequency by Two-Week Intervals Through Week 14
Titration (2 Weeks)
|
-2.98 number of panic attacks/14 days
Standard Deviation 3.724
|
-3.03 number of panic attacks/14 days
Standard Deviation 3.658
|
|
Change From Baseline in Panic Attack Frequency by Two-Week Intervals Through Week 14
Maintenance Week 1-2
|
-3.54 number of panic attacks/14 days
Standard Deviation 3.019
|
-3.97 number of panic attacks/14 days
Standard Deviation 4.626
|
|
Change From Baseline in Panic Attack Frequency by Two-Week Intervals Through Week 14
Maintenance Week 3-4
|
-4.60 number of panic attacks/14 days
Standard Deviation 3.344
|
-4.99 number of panic attacks/14 days
Standard Deviation 4.374
|
|
Change From Baseline in Panic Attack Frequency by Two-Week Intervals Through Week 14
Maintenance Week 5-6
|
-4.76 number of panic attacks/14 days
Standard Deviation 3.647
|
-5.17 number of panic attacks/14 days
Standard Deviation 4.709
|
|
Change From Baseline in Panic Attack Frequency by Two-Week Intervals Through Week 14
Maintenance Week 7-8
|
-4.62 number of panic attacks/14 days
Standard Deviation 4.781
|
-5.37 number of panic attacks/14 days
Standard Deviation 4.243
|
|
Change From Baseline in Panic Attack Frequency by Two-Week Intervals Through Week 14
Maintenance Week 9-10
|
-5.33 number of panic attacks/14 days
Standard Deviation 3.630
|
-5.50 number of panic attacks/14 days
Standard Deviation 4.948
|
|
Change From Baseline in Panic Attack Frequency by Two-Week Intervals Through Week 14
Maintenance Week 11-12
|
-5.55 number of panic attacks/14 days
Standard Deviation 3.329
|
-5.10 number of panic attacks/14 days
Standard Deviation 5.381
|
|
Change From Baseline in Panic Attack Frequency by Two-Week Intervals Through Week 14
Last Two Weeks of Maintenance Treatment Prior to Subject's Completion/Early Termination*
|
-5.29 number of panic attacks/14 days
Standard Deviation 3.383
|
-5.30 number of panic attacks/14 days
Standard Deviation 4.973
|
SECONDARY outcome
Timeframe: Baseline through Week 14Population: Full Analysis Set: Expanded
The Clinical Global Impression-Severity (CGI-S) scale is a single item 7-point scale, with panic order severity rated from 1 (normal) through to 7 (most severely ill). Change from baseline = value - baseline value; n = number of participants with a non-missing value; overall N = number of participants in treatment group.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants received darigabat matching placebo, orally, BID for 2 weeks during the Titration Period and thereafter for 12 weeks during the Maintenance Treatment Period.
|
Darigabat 25 mg BID
n=34 Participants
Participants received darigabat, up to a maximum dose of 12.5 mg, orally, BID, for 2 weeks during the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks during the Maintenance Treatment Period.
|
|---|---|---|
|
Change From Baseline at All Time Points up to Week 14 in the Clinical Global Impression-Severity of Symptoms Scale (CGI-S) Score
Visit 6 (Day 98)
|
-2.3 units on a scale
Standard Error 0.54
|
-2.6 units on a scale
Standard Error 0.52
|
|
Change From Baseline at All Time Points up to Week 14 in the Clinical Global Impression-Severity of Symptoms Scale (CGI-S) Score
Visit 3 (Day 14)
|
-1.2 units on a scale
Standard Error 0.51
|
-1.3 units on a scale
Standard Error 0.48
|
|
Change From Baseline at All Time Points up to Week 14 in the Clinical Global Impression-Severity of Symptoms Scale (CGI-S) Score
Visit 4 (Day 42)
|
-1.9 units on a scale
Standard Error 0.53
|
-2.0 units on a scale
Standard Error 0.52
|
|
Change From Baseline at All Time Points up to Week 14 in the Clinical Global Impression-Severity of Symptoms Scale (CGI-S) Score
Visit 5 (Day 70)
|
-2.0 units on a scale
Standard Error 0.55
|
-2.6 units on a scale
Standard Error 0.54
|
SECONDARY outcome
Timeframe: Baseline through Week 14Population: Full Analysis Set: Expanded
The Hamilton Anxiety Scale (HAM-A) is a 14-item scale measures severity of anxiety symptoms. Each item is scored on a scale from 0 (not present) to 4 (severe) resulting in a total score range of 0 to 56, with higher scores indicating more severe anxiety. Change from baseline = value - baseline value; n = number of participants with a non-missing value; overall N = number of participants in treatment group.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants received darigabat matching placebo, orally, BID for 2 weeks during the Titration Period and thereafter for 12 weeks during the Maintenance Treatment Period.
|
Darigabat 25 mg BID
n=34 Participants
Participants received darigabat, up to a maximum dose of 12.5 mg, orally, BID, for 2 weeks during the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks during the Maintenance Treatment Period.
|
|---|---|---|
|
Change From Baseline at All Time Points up to Week 14 in the Hamilton Anxiety Scale (HAM-A) Total Score
Visit 3 (Day 14)
|
-5.3 units on a scale
Standard Error 4.25
|
-6.2 units on a scale
Standard Error 4.00
|
|
Change From Baseline at All Time Points up to Week 14 in the Hamilton Anxiety Scale (HAM-A) Total Score
Visit 4 (Day 42)
|
-7.9 units on a scale
Standard Error 4.28
|
-8.2 units on a scale
Standard Error 4.13
|
|
Change From Baseline at All Time Points up to Week 14 in the Hamilton Anxiety Scale (HAM-A) Total Score
Visit 5 (Day 70)
|
-11.2 units on a scale
Standard Error 4.34
|
-10.5 units on a scale
Standard Error 4.20
|
|
Change From Baseline at All Time Points up to Week 14 in the Hamilton Anxiety Scale (HAM-A) Total Score
Visit 6 (Day 98)
|
-11.2 units on a scale
Standard Error 4.30
|
-12.4 units on a scale
Standard Error 4.14
|
SECONDARY outcome
Timeframe: From Day 1 through Week 18Population: Safety Analysis Set
A Treatment-Emergent Adverse Event (TEAE) is any event reported on the CRF that occurs on or after the initiation of IMP and through follow-up contact.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants received darigabat matching placebo, orally, BID for 2 weeks during the Titration Period and thereafter for 12 weeks during the Maintenance Treatment Period.
|
Darigabat 25 mg BID
n=40 Participants
Participants received darigabat, up to a maximum dose of 12.5 mg, orally, BID, for 2 weeks during the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks during the Maintenance Treatment Period.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
20 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Up to Week 14Population: Safety Analysis Set
12-lead ECGs recordings were obtained after the participant had been supine and at rest for at least 3 minutes. The number of participants with significant abnormalities is reported by 'change from baseline in QT interval as corrected for heart rate by Fridericia's formula (QTcF)'.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants received darigabat matching placebo, orally, BID for 2 weeks during the Titration Period and thereafter for 12 weeks during the Maintenance Treatment Period.
|
Darigabat 25 mg BID
n=40 Participants
Participants received darigabat, up to a maximum dose of 12.5 mg, orally, BID, for 2 weeks during the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks during the Maintenance Treatment Period.
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Results
Change from Baseline in QTcF Interval > 60 msec
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Results
Change from Baseline in QTcF Interval > 30 - 60 msec
|
2 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Results
Absolute QTcF Interval > 450 and ≤ 480 msec
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Results
Absolute QTcF Interval > 480 and ≤ 500 msec
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Results
Absolute QTcF Interval > 500 msec
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 18Population: Safety Analysis Set
Protocol-required safety laboratory tests were performed, including hematology, chemistry and urinalysis tests. Reported here is the number of participants with clinically significant changes in these laboratory tests.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants received darigabat matching placebo, orally, BID for 2 weeks during the Titration Period and thereafter for 12 weeks during the Maintenance Treatment Period.
|
Darigabat 25 mg BID
n=40 Participants
Participants received darigabat, up to a maximum dose of 12.5 mg, orally, BID, for 2 weeks during the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks during the Maintenance Treatment Period.
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessment Values
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to Week 14Population: Safety Analysis Set
Vital signs were measured with the participant in a sitting/semi-recumbent position after 3 minutes rest and included temperature, systolic and diastolic blood pressure, respiratory rate, and heart rate. Reported here is the number of participants with clinically significant changes in vital sign measurements.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants received darigabat matching placebo, orally, BID for 2 weeks during the Titration Period and thereafter for 12 weeks during the Maintenance Treatment Period.
|
Darigabat 25 mg BID
n=40 Participants
Participants received darigabat, up to a maximum dose of 12.5 mg, orally, BID, for 2 weeks during the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks during the Maintenance Treatment Period.
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Supine Systolic Blood Pressure < 90 mmHg
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Supine Systolic Blood Pressure > 140 mmHg
|
1 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Respiratory Rate > 20 breaths/min
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Temperature < 36 °C
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Body Weight ≥ 7% decrease
|
0 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Temperature > 38 °C
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Body Weight ≥ 7% increase
|
0 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Orthostatic Systolic Blood Pressure ≥ 20 mmHg decrease upon standing compared with supine position
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Supine Diastolic Blood Pressure < 50 mmHg
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Supine Diastolic Blood Pressure > 90 mmHg
|
1 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Orthostatic Diastolic Blood Pressure ≥ 10 mmHg decrease upon standing compared with supine position
|
0 Participants
|
5 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Heart Rate < 60 bpm
|
7 Participants
|
8 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Heart Rate > 100 bpm
|
0 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Respiratory Rate < 12 breaths/min
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 14Population: Safety Analysis Set
A complete physical examination consisted of measurement of weight and a review of the following body systems: head, ears, eyes, nose, mouth, skin, heart, lungs, lymph nodes, and gastrointestinal, genitourinary, and musculoskeletal systems. A full neurological examination included an assessment of the participant's mental status (level of consciousness, orientation, speech, memory, etc), cranial nerves, motor (muscle appearance, tone, strength, and reflexes), sensation (including Romberg sign), coordination, and gait. Reported here is the number of participants with clinically significant changes in physical or neurological examination results.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants received darigabat matching placebo, orally, BID for 2 weeks during the Titration Period and thereafter for 12 weeks during the Maintenance Treatment Period.
|
Darigabat 25 mg BID
n=40 Participants
Participants received darigabat, up to a maximum dose of 12.5 mg, orally, BID, for 2 weeks during the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks during the Maintenance Treatment Period.
|
|---|---|---|
|
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Number of participants with any clinically significant physical examination findings
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Number of participants with any clinically significant neurological examination findings
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to Week 14Population: Safety Analysis Set
The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent). Reported here is the number of participants with changes in suicidality assessed using the C-SSRS scale.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants received darigabat matching placebo, orally, BID for 2 weeks during the Titration Period and thereafter for 12 weeks during the Maintenance Treatment Period.
|
Darigabat 25 mg BID
n=40 Participants
Participants received darigabat, up to a maximum dose of 12.5 mg, orally, BID, for 2 weeks during the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks during the Maintenance Treatment Period.
|
|---|---|---|
|
Number of Participants With Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Treatment-Emergent Suicidal Ideation (1-5) Compared to Recent History
|
1 Participants
|
1 Participants
|
|
Number of Participants With Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Treatment-Emergent Serious Suicidal Ideation (0-3 to 4-5) Compared to Recent History
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Emergence of Serious Suicidal Ideation (0 to 4-5) Compared to Recent History
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Emergence of Suicidal Behavior (6-10) Compared to all Prior History
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 15Population: Safety Analysis Set
The PWC is a 20-item scale to measure discontinuation symptoms after stopping a medication for anxiety disorders. All 20 items are rated on a 4-point numeric-rating scale ranging from 0 (not present), 1 (mild), 2 (moderate), to 3 (severe). A total score, ranging 0 to 60, was calculated in addition to the individual scores for each item. Lower scores indicate less severity in discontinuation symptoms. Reported here is the number of participants with withdrawal symptoms assessed using the PWC.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants received darigabat matching placebo, orally, BID for 2 weeks during the Titration Period and thereafter for 12 weeks during the Maintenance Treatment Period.
|
Darigabat 25 mg BID
n=40 Participants
Participants received darigabat, up to a maximum dose of 12.5 mg, orally, BID, for 2 weeks during the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks during the Maintenance Treatment Period.
|
|---|---|---|
|
Number of Participants With Withdrawal Symptoms Assessed Using the Penn Physician's Withdrawal Checklist (PWC)
|
0 Participants
|
1 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Darigabat 25 mg BID
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=40 participants at risk
Participants received darigabat matching placebo, orally, BID for 2 weeks during the Titration Period and thereafter for 12 weeks during the Maintenance Treatment Period.
|
Darigabat 25 mg BID
n=40 participants at risk
Participants received darigabat, up to a maximum dose of 12.5 mg, orally, BID, for two weeks in the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks in the Maintenance Treatment Period.
|
|---|---|---|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Psychiatric disorders
PANIC ATTACK
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK FIRST DEGREE
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Gastrointestinal disorders
DIARRHOEA
|
5.0%
2/40 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Gastrointestinal disorders
NAUSEA
|
10.0%
4/40 • Number of events 10 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
7.5%
3/40 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Gastrointestinal disorders
VOMITING
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
General disorders
DRUG WITHDRAWAL SYNDROME
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
2.5%
1/40 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
General disorders
FATIGUE
|
5.0%
2/40 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
5.0%
2/40 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Infections and infestations
COVID-19
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Infections and infestations
NASOPHARYNGITIS
|
5.0%
2/40 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
10.0%
4/40 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
7.5%
3/40 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
5.0%
2/40 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
5.0%
2/40 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Blood and lymphatic system disorders
EOSINOPHILIA
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Investigations
BLOOD CREATININE INCREASED
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
2.5%
1/40 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
5.0%
2/40 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Nervous system disorders
BALANCE DISORDER
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
5.0%
2/40 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Nervous system disorders
COGNITIVE DISORDER
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Nervous system disorders
DIZZINESS
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
12.5%
5/40 • Number of events 5 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Nervous system disorders
HEADACHE
|
20.0%
8/40 • Number of events 8 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
5.0%
2/40 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Nervous system disorders
SCIATICA
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
10.0%
4/40 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Psychiatric disorders
ANXIETY
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Psychiatric disorders
NIGHTMARE
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Reproductive system and breast disorders
PRURITUS GENITAL
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
2.5%
1/40 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/40 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
2.5%
1/40 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time informed consent was signed to the end of the study. The median time on follow-up was 131.5 days for the Placebo group and 132 days for the Darigabat 25 mg BID group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER