Trial Outcomes & Findings for Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone (NCT NCT03738215)
NCT ID: NCT03738215
Last Updated: 2022-10-25
Results Overview
The MADRS is a 10-item, clinician-rated scale that evaluates the patient's depressive symptomatology during the past week. Patients are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. mITT Population included all randomized participants who had ≥1 postbaseline assessment of the MADRS total score. Number of subjects analyzed are the number of participants with data available for analyses.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
759 participants
Primary outcome timeframe
Baseline and Week 6
Results posted on
2022-10-25
Participant Flow
A total of 759 participants were randomized to double-blind treatment, 757 participants received at least 1 dose of double-blind investigational product (safety population), and 751 treated participants had at least 1 postbaseline assessment of MADRS total score (modified intent-to-treat \[mITT\] population ). At the end of treatment in the Double-blind Period, participants continued on their background antidepressant therapy (ADT) and entered the Safety Follow-up Period.
Participant milestones
| Measure |
Placebo + ADT
During the double blind treatment period (6 weeks), participants will take 1 capsule of placebo, orally, per day in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline).
Placebo: Placebo supplied in capsules
|
Cariprazine 1.5 mg/Day + ADT
During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline).
Cariprazine: Cariprazine supplied in capsules
|
Cariprazine 3 mg/Day + ADT
During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day for two weeks in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline). They will then titrate to Cariprazine 3 mg, orally per day, in addition to their ADT starting at Visit 4 (Week 2).
Cariprazine: Cariprazine supplied in capsules
|
|---|---|---|---|
|
Double-blind Treatment Period (6 Weeks)
STARTED
|
253
|
252
|
252
|
|
Double-blind Treatment Period (6 Weeks)
COMPLETED
|
229
|
231
|
219
|
|
Double-blind Treatment Period (6 Weeks)
NOT COMPLETED
|
24
|
21
|
33
|
|
Safety Follow Up Period (4 Weeks)
STARTED
|
240
|
239
|
238
|
|
Safety Follow Up Period (4 Weeks)
COMPLETED
|
237
|
234
|
230
|
|
Safety Follow Up Period (4 Weeks)
NOT COMPLETED
|
3
|
5
|
8
|
Reasons for withdrawal
| Measure |
Placebo + ADT
During the double blind treatment period (6 weeks), participants will take 1 capsule of placebo, orally, per day in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline).
Placebo: Placebo supplied in capsules
|
Cariprazine 1.5 mg/Day + ADT
During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline).
Cariprazine: Cariprazine supplied in capsules
|
Cariprazine 3 mg/Day + ADT
During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day for two weeks in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline). They will then titrate to Cariprazine 3 mg, orally per day, in addition to their ADT starting at Visit 4 (Week 2).
Cariprazine: Cariprazine supplied in capsules
|
|---|---|---|---|
|
Double-blind Treatment Period (6 Weeks)
Protocol Violation
|
0
|
1
|
0
|
|
Double-blind Treatment Period (6 Weeks)
Lack of Efficacy
|
2
|
2
|
0
|
|
Double-blind Treatment Period (6 Weeks)
Adverse Event
|
6
|
3
|
18
|
|
Double-blind Treatment Period (6 Weeks)
Withdrawal by Subject
|
13
|
11
|
9
|
|
Double-blind Treatment Period (6 Weeks)
Non-Compliance with Study Drug
|
0
|
1
|
1
|
|
Double-blind Treatment Period (6 Weeks)
Lost to Follow-up
|
3
|
3
|
5
|
|
Safety Follow Up Period (4 Weeks)
Adverse Event
|
0
|
0
|
1
|
|
Safety Follow Up Period (4 Weeks)
Reason Not Specified
|
0
|
2
|
0
|
|
Safety Follow Up Period (4 Weeks)
Withdrawal by Subject
|
1
|
1
|
3
|
|
Safety Follow Up Period (4 Weeks)
Lost to Follow-up
|
2
|
2
|
4
|
Baseline Characteristics
Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone
Baseline characteristics by cohort
| Measure |
Placebo + ADT
n=253 Participants
During the double blind treatment period (6 weeks), participants will take 1 capsule of placebo, orally, per day in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline).
Placebo: Placebo supplied in capsules
|
Cariprazine 1.5 mg/Day + ADT
n=252 Participants
During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline).
Cariprazine: Cariprazine supplied in capsules
|
Cariprazine 3 mg/Day + ADT
n=252 Participants
During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day for two weeks in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline). They will then titrate to Cariprazine 3 mg, orally per day, in addition to their ADT starting at Visit 4 (Week 2).
Cariprazine: Cariprazine supplied in capsules
|
Total
n=757 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.4 years
STANDARD_DEVIATION 11.89 • n=5 Participants
|
43.3 years
STANDARD_DEVIATION 13.59 • n=7 Participants
|
44.8 years
STANDARD_DEVIATION 13.33 • n=5 Participants
|
44.8 years
STANDARD_DEVIATION 13.00 • n=4 Participants
|
|
Sex: Female, Male
Female
|
184 Participants
n=5 Participants
|
191 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
555 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
202 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
228 Participants
n=5 Participants
|
228 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
689 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
43 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
203 Participants
n=5 Participants
|
205 Participants
n=7 Participants
|
215 Participants
n=5 Participants
|
623 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
152 participants
n=5 Participants
|
153 participants
n=7 Participants
|
153 participants
n=5 Participants
|
458 participants
n=4 Participants
|
|
Region of Enrollment
Bulgaria
|
35 participants
n=5 Participants
|
34 participants
n=7 Participants
|
34 participants
n=5 Participants
|
103 participants
n=4 Participants
|
|
Region of Enrollment
Estonia
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
9 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
12 participants
n=5 Participants
|
37 participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Region of Enrollment
Ukraine
|
33 participants
n=5 Participants
|
33 participants
n=7 Participants
|
34 participants
n=5 Participants
|
100 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
9 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 6Population: mITT population includes all randomized participants who had ≥ 1 postbaseline assessment of the MADRS total score.
The MADRS is a 10-item, clinician-rated scale that evaluates the patient's depressive symptomatology during the past week. Patients are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. mITT Population included all randomized participants who had ≥1 postbaseline assessment of the MADRS total score. Number of subjects analyzed are the number of participants with data available for analyses.
Outcome measures
| Measure |
Placebo + ADT
n=231 Participants
During the double blind treatment period (6 weeks), participants will take 1 capsule of placebo, orally, per day in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline).
Placebo: Placebo supplied in capsules
|
Cariprazine 1.5 mg/Day + ADT
n=231 Participants
During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline).
Cariprazine: Cariprazine supplied in capsules
|
Cariprazine 3 mg/Day + ADT
n=223 Participants
During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day for two weeks in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline). They will then titrate to Cariprazine 3 mg, orally per day, in addition to their ADT starting at Visit 4 (Week 2).
Cariprazine: Cariprazine supplied in capsules
|
|---|---|---|---|
|
Total Score Change From Baseline to Week 6 in the MADRS (Montgomery-Åsberg Depression Rating Scale)
|
-11.5 score on a scale
Standard Error 0.70
|
-14.1 score on a scale
Standard Error 0.70
|
-13.1 score on a scale
Standard Error 0.70
|
SECONDARY outcome
Timeframe: Baseline and Week 6Population: mITT population includes all randomized participants who had ≥ 1 postbaseline assessment of the MADRS total score.
The CGI-S is a clinician-rated scale used to rate the severity of the participant's current state of mental illness compared with MDD population. The participant was rated on a scale from 1 to 7, where 1=normal, not at all ill and 7=among the most extremely ill participants. Higher scores indicate worsening of mental illness. A negative change from Baseline indicates improvement. MMRM was used for analyses. mITT Population included all randomized participants who had ≥1 postbaseline assessment of the MADRS total score. Number of subjects analyzed are the number of participants with data available for analyses.
Outcome measures
| Measure |
Placebo + ADT
n=231 Participants
During the double blind treatment period (6 weeks), participants will take 1 capsule of placebo, orally, per day in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline).
Placebo: Placebo supplied in capsules
|
Cariprazine 1.5 mg/Day + ADT
n=231 Participants
During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline).
Cariprazine: Cariprazine supplied in capsules
|
Cariprazine 3 mg/Day + ADT
n=223 Participants
During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day for two weeks in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline). They will then titrate to Cariprazine 3 mg, orally per day, in addition to their ADT starting at Visit 4 (Week 2).
Cariprazine: Cariprazine supplied in capsules
|
|---|---|---|---|
|
Change From Baseline to Week 6 in the Clinical Global Impressions-Severity (CGI-S) Score
|
-1.1 score on a scale
Standard Error 0.09
|
-1.4 score on a scale
Standard Error 0.09
|
-1.3 score on a scale
Standard Error 0.09
|
Adverse Events
Placebo + ADT
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
Cariprazine 1.5 mg/Day + ADT
Serious events: 3 serious events
Other events: 68 other events
Deaths: 0 deaths
Cariprazine 3 mg/Day + ADT
Serious events: 3 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + ADT
n=253 participants at risk
During the double blind treatment period (6 weeks), participants will take 1 capsule of placebo, orally, per day in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline).
Placebo: Placebo supplied in capsules
|
Cariprazine 1.5 mg/Day + ADT
n=252 participants at risk
During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline).
Cariprazine: Cariprazine supplied in capsules
|
Cariprazine 3 mg/Day + ADT
n=252 participants at risk
During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day for two weeks in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline). They will then titrate to Cariprazine 3 mg, orally per day, in addition to their ADT starting at Visit 4 (Week 2).
Cariprazine: Cariprazine supplied in capsules
|
|---|---|---|---|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/253 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
0.00%
0/252 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
0.40%
1/252 • Number of events 1 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
|
Infections and infestations
KIDNEY INFECTION
|
0.00%
0/253 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
0.00%
0/252 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
0.40%
1/252 • Number of events 1 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/253 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
0.40%
1/252 • Number of events 1 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
0.00%
0/252 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
|
Injury, poisoning and procedural complications
FIBULA FRACTURE
|
0.00%
0/253 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
0.40%
1/252 • Number of events 1 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
0.00%
0/252 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
0.00%
0/253 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
0.40%
1/252 • Number of events 1 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
0.00%
0/252 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
|
Nervous system disorders
MULTIPLE SCLEROSIS
|
0.40%
1/253 • Number of events 1 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
0.00%
0/252 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
0.00%
0/252 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.00%
0/253 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
0.40%
1/252 • Number of events 1 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
0.00%
0/252 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
|
Psychiatric disorders
DEPRESSION
|
0.40%
1/253 • Number of events 1 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
0.00%
0/252 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
0.40%
1/252 • Number of events 1 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
|
Social circumstances
SOCIAL STAY HOSPITALISATION
|
0.00%
0/253 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
0.40%
1/252 • Number of events 1 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
0.00%
0/252 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
Other adverse events
| Measure |
Placebo + ADT
n=253 participants at risk
During the double blind treatment period (6 weeks), participants will take 1 capsule of placebo, orally, per day in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline).
Placebo: Placebo supplied in capsules
|
Cariprazine 1.5 mg/Day + ADT
n=252 participants at risk
During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline).
Cariprazine: Cariprazine supplied in capsules
|
Cariprazine 3 mg/Day + ADT
n=252 participants at risk
During the double blind treatment period (6 weeks), participants will take 1 capsule of cariprazine 1.5mg, orally, per day for two weeks in addition to their ongoing ADT (Same antidepressant and dose of ADT they were on at the Visit 2 baseline). They will then titrate to Cariprazine 3 mg, orally per day, in addition to their ADT starting at Visit 4 (Week 2).
Cariprazine: Cariprazine supplied in capsules
|
|---|---|---|---|
|
Gastrointestinal disorders
NAUSEA
|
2.4%
6/253 • Number of events 6 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
7.9%
20/252 • Number of events 21 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
6.3%
16/252 • Number of events 19 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
|
Nervous system disorders
AKATHISIA
|
1.2%
3/253 • Number of events 3 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
5.2%
13/252 • Number of events 14 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
7.9%
20/252 • Number of events 23 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
|
Nervous system disorders
HEADACHE
|
6.3%
16/253 • Number of events 19 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
9.5%
24/252 • Number of events 25 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
4.4%
11/252 • Number of events 23 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
|
Nervous system disorders
SOMNOLENCE
|
2.8%
7/253 • Number of events 7 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
5.2%
13/252 • Number of events 13 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
4.4%
11/252 • Number of events 12 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
|
Psychiatric disorders
INSOMNIA
|
4.3%
11/253 • Number of events 18 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
7.1%
18/252 • Number of events 18 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
6.3%
16/252 • Number of events 16 • First Dose of study drug until 30 days after the last dose of study drug (up to 12 weeks)
Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place