Trial Outcomes & Findings for A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation (NCT NCT01862640)
NCT ID: NCT01862640
Last Updated: 2020-12-31
Results Overview
To compare the efficacy of 2 fixed doses (1 mg/day and 2 mg/day) of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type, by the assessment of CMAI after 12 weeks of treatment. The CMAI assesses the frequency of agitated behaviors in elderly persons, such as hitting, cursing, and restlessness. It consists of 29 items all rated on a 1 to 7 scale with 1 being the "best" rating and 7 being the "worst" rating. The minimum possible CMAI total score is 29, and the maximum possible CMAI total score is 203. A decrease in score indicates improvement in symptoms. To control the overall type I error at 0.05 level when making 2 comparisons of brexpiprazole doses versus placebo, statistical testing was carried out using a hierarchical testing procedure in the order of: 1) comparison of 2 mg/day brexpiprazole versus placebo, and 2) comparison of 1 mg/day brexpiprazole versus placebo.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
433 participants
Primary outcome timeframe
Baseline, Week 12/Early Termination (ET)
Results posted on
2020-12-31
Participant Flow
Participants who met all the inclusion and none of the exclusion criteria were enrolled in this study. The study was conducted in 433 participants at 81 sites in 7 countries: Croatia, Germany, Serbia, Spain, Russia, Ukraine, and the United States.
Participants attended a screening period ranging from 2 to 42 days. The purpose of the screening period was to determine the participant's eligibility and to washout prohibited concomitant pharmacotherapy prior to randomization.
Participant milestones
| Measure |
Brexpiprazole 0.5 mg/Day
All randomized participants received orally brexpiprazole 0.25 milligrams (mg)/day as a starting dose, which was up titrated to 0.5 mg/day. The investigational medicinal product (IMP) was administered once daily in the form of a tablet.
|
Brexpiprazole 1 mg/Day
All randomized participants received orally brexpiprazole 0.25 mg/day as a starting dose, which was up titrated to 1 mg/day. The IMP was administered once daily in the form of a tablet.
|
Brexpiprazole 2 mg/Day
All randomized participants received orally brexpiprazole 0.25 mg/day as a starting dose, which was up titrated to 2 mg/day. The IMP was administered once daily in the form of a tablet.
|
Placebo
All randomized participants received orally brexpiprazole-matching Placebo. The Placebo was administered once daily in the form of a tablet.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
137
|
140
|
136
|
|
Overall Study
COMPLETED
|
13
|
121
|
122
|
121
|
|
Overall Study
NOT COMPLETED
|
7
|
16
|
18
|
15
|
Reasons for withdrawal
| Measure |
Brexpiprazole 0.5 mg/Day
All randomized participants received orally brexpiprazole 0.25 milligrams (mg)/day as a starting dose, which was up titrated to 0.5 mg/day. The investigational medicinal product (IMP) was administered once daily in the form of a tablet.
|
Brexpiprazole 1 mg/Day
All randomized participants received orally brexpiprazole 0.25 mg/day as a starting dose, which was up titrated to 1 mg/day. The IMP was administered once daily in the form of a tablet.
|
Brexpiprazole 2 mg/Day
All randomized participants received orally brexpiprazole 0.25 mg/day as a starting dose, which was up titrated to 2 mg/day. The IMP was administered once daily in the form of a tablet.
|
Placebo
All randomized participants received orally brexpiprazole-matching Placebo. The Placebo was administered once daily in the form of a tablet.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
10
|
6
|
8
|
|
Overall Study
Participant Met Withdrawal Criteria
|
1
|
1
|
2
|
1
|
|
Overall Study
Participant Withdrawn by Investigator
|
0
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
8
|
5
|
|
Overall Study
Protocol Deviation
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation
Baseline characteristics by cohort
| Measure |
Brexpiprazole 0.5 mg/Day
n=20 Participants
All randomized participants received orally brexpiprazole 0.25 milligrams (mg)/day as a starting dose, which was up titrated to 0.5 mg/day. The investigational medicinal product (IMP) was administered once daily in the form of a tablet.
|
Brexpiprazole 1 mg/Day
n=137 Participants
All randomized participants received orally brexpiprazole 0.25 mg/day as a starting dose, which was up titrated to 1 mg/day. The IMP was administered once daily in the form of a tablet.
|
Brexpiprazole 2 mg/Day
n=140 Participants
All randomized participants received orally brexpiprazole 0.25 mg/day as a starting dose, which was up titrated to 2 mg/day. The IMP was administered once daily in the form of a tablet.
|
Placebo
n=136 Participants
All randomized participants received orally brexpiprazole-matching Placebo. The Placebo was administered once daily in the form of a tablet.
|
Total
n=433 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
73.9 years
STANDARD_DEVIATION 9.1 • n=93 Participants
|
73.8 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
73.7 years
STANDARD_DEVIATION 8.1 • n=27 Participants
|
74.1 years
STANDARD_DEVIATION 8.0 • n=483 Participants
|
73.9 years
STANDARD_DEVIATION 8.3 • n=36 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
78 Participants
n=4 Participants
|
79 Participants
n=27 Participants
|
70 Participants
n=483 Participants
|
239 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
66 Participants
n=483 Participants
|
194 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=93 Participants
|
134 Participants
n=4 Participants
|
133 Participants
n=27 Participants
|
130 Participants
n=483 Participants
|
417 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12/Early Termination (ET)Population: The modified intention-to-treat population consisted of all participants in the randomized sample who took at least 1 dose of IMP (excluding 20 subjects randomized to Brexpiprazole 0.5 mg/day, as doses lower than 1 mg/day were unlikely to be efficacious) and had a baseline and at least 1 post baseline evaluation for the CMAI total score.
To compare the efficacy of 2 fixed doses (1 mg/day and 2 mg/day) of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type, by the assessment of CMAI after 12 weeks of treatment. The CMAI assesses the frequency of agitated behaviors in elderly persons, such as hitting, cursing, and restlessness. It consists of 29 items all rated on a 1 to 7 scale with 1 being the "best" rating and 7 being the "worst" rating. The minimum possible CMAI total score is 29, and the maximum possible CMAI total score is 203. A decrease in score indicates improvement in symptoms. To control the overall type I error at 0.05 level when making 2 comparisons of brexpiprazole doses versus placebo, statistical testing was carried out using a hierarchical testing procedure in the order of: 1) comparison of 2 mg/day brexpiprazole versus placebo, and 2) comparison of 1 mg/day brexpiprazole versus placebo.
Outcome measures
| Measure |
Brexpiprazole 2 mg/Day
n=138 Participants
All randomized participants received orally brexpiprazole 0.25 mg/day as a starting dose, which was up titrated to 2 mg/day. The IMP was administered once daily in the form of a tablet.
|
Brexpiprazole 1 mg/Day
n=134 Participants
All randomized participants received orally brexpiprazole 0.25 mg/day as a starting dose, which was up titrated to 1 mg/day. The IMP was administered once daily in the form of a tablet.
|
Placebo
n=131 Participants
All randomized participants received orally brexpiprazole-matching Placebo. The Placebo was administered once daily in the form of a tablet.
|
|---|---|---|---|
|
Change From Baseline In The Cohen-Mansfield Agitation Inventory (CMAI) Total Score After 12 Weeks Of Brexpiprazole Treatment
|
-21.6 units on a scale
Standard Error 1.32
|
-17.6 units on a scale
Standard Error 1.33
|
-17.8 units on a scale
Standard Error 1.34
|
SECONDARY outcome
Timeframe: Baseline, Week 12/ETPopulation: The modified intention-to-treat population consisted of all participants in the randomized sample who took at least 1 dose of IMP (excluding 20 participants randomized to Brexpiprazole 0.5 mg/day) and had a baseline and at least 1 post baseline evaluation for the CMAI total score.
To compare the efficacy of 2 fixed doses (1 mg/day and 2 mg/day) of brexpiprazole with placebo in participants with agitation associated with Alzheimer's dementia, by the assessment of CGI-S score after 12 weeks of treatment. The CGI-S was used to rate the severity of agitation. Scores were: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. A decrease in score indicates improvement in symptoms.
Outcome measures
| Measure |
Brexpiprazole 2 mg/Day
n=138 Participants
All randomized participants received orally brexpiprazole 0.25 mg/day as a starting dose, which was up titrated to 2 mg/day. The IMP was administered once daily in the form of a tablet.
|
Brexpiprazole 1 mg/Day
n=134 Participants
All randomized participants received orally brexpiprazole 0.25 mg/day as a starting dose, which was up titrated to 1 mg/day. The IMP was administered once daily in the form of a tablet.
|
Placebo
n=131 Participants
All randomized participants received orally brexpiprazole-matching Placebo. The Placebo was administered once daily in the form of a tablet.
|
|---|---|---|---|
|
Change From Baseline In The Clinical Global Impression-Severity Of Illness (CGI-S) Score, As Related To Symptoms Of Agitation After 12 Weeks Of Brexpiprazole Treatment
|
-1.29 units on a scale
Standard Deviation 1.05
|
-1.04 units on a scale
Standard Deviation 1.12
|
-1.08 units on a scale
Standard Deviation 0.89
|
Adverse Events
Brexpiprazole 0.5 mg/Day
Serious events: 5 serious events
Other events: 11 other events
Deaths: 2 deaths
Brexpiprazole 1 mg/Day
Serious events: 11 serious events
Other events: 27 other events
Deaths: 2 deaths
Brexpiprazole 2 mg/Day
Serious events: 13 serious events
Other events: 43 other events
Deaths: 1 deaths
Placebo
Serious events: 7 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brexpiprazole 0.5 mg/Day
n=20 participants at risk
All randomized participants received orally brexpiprazole 0.25 milligrams (mg)/day as a starting dose, which was up titrated to 0.5 mg/day. The investigational medicinal product (IMP) was administered once daily in the form of a tablet.
|
Brexpiprazole 1 mg/Day
n=137 participants at risk
All randomized participants received orally brexpiprazole 0.25 mg/day as a starting dose, which was up titrated to 1 mg/day. The IMP was administered once daily in the form of a tablet.
|
Brexpiprazole 2 mg/Day
n=140 participants at risk
All randomized participants received orally brexpiprazole 0.25 mg/day as a starting dose, which was up titrated to 2 mg/day. The IMP was administered once daily in the form of a tablet.
|
Placebo
n=135 participants at risk
All randomized participants received orally brexpiprazole-matching Placebo. The Placebo was administered once daily in the form of a tablet.
|
|---|---|---|---|---|
|
Nervous system disorders
Dementia Alzheimer's Type
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.73%
1/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.71%
1/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.73%
1/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.71%
1/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Blood and lymphatic system disorders
Microcytic Anaemia
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.71%
1/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Gastrointestinal disorders
Duodenal Ulcer Haemorrhage
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.74%
1/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.73%
1/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
General disorders
Pyrexia
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.73%
1/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Infections and infestations
Bacterial Sepsis
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.73%
1/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Infections and infestations
Cellulitis
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.73%
1/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Infections and infestations
Encephalitis
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.74%
1/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
2.9%
4/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.74%
1/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Injury, poisoning and procedural complications
Patella Fracture
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.74%
1/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.73%
1/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Nervous system disorders
Haemorrhage Intracranial
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Nervous system disorders
Lacunar Infarction
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.73%
1/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Nervous system disorders
Psychomotor Hyperactivity
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.71%
1/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Nervous system disorders
Seizure
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.74%
1/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Nervous system disorders
Syncope
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.73%
1/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.74%
1/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.74%
1/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Psychiatric disorders
Abnormal Behaviour
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.73%
1/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Psychiatric disorders
Agitation
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.73%
1/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.71%
1/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Psychiatric disorders
Delusion
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.73%
1/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Psychiatric disorders
Intentional Self-Injury
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.74%
1/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Psychiatric disorders
Psychotic Disorder
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.71%
1/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.71%
1/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.71%
1/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive Airways Disorder
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.73%
1/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.73%
1/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.71%
1/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Vascular disorders
Venous Thrombosis Limb
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.71%
1/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
Other adverse events
| Measure |
Brexpiprazole 0.5 mg/Day
n=20 participants at risk
All randomized participants received orally brexpiprazole 0.25 milligrams (mg)/day as a starting dose, which was up titrated to 0.5 mg/day. The investigational medicinal product (IMP) was administered once daily in the form of a tablet.
|
Brexpiprazole 1 mg/Day
n=137 participants at risk
All randomized participants received orally brexpiprazole 0.25 mg/day as a starting dose, which was up titrated to 1 mg/day. The IMP was administered once daily in the form of a tablet.
|
Brexpiprazole 2 mg/Day
n=140 participants at risk
All randomized participants received orally brexpiprazole 0.25 mg/day as a starting dose, which was up titrated to 2 mg/day. The IMP was administered once daily in the form of a tablet.
|
Placebo
n=135 participants at risk
All randomized participants received orally brexpiprazole-matching Placebo. The Placebo was administered once daily in the form of a tablet.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.73%
1/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
1.4%
2/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.73%
1/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
3.6%
5/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.74%
1/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Gastrointestinal disorders
Salivary Hypersecretion
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.71%
1/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
General disorders
Asthenia
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
1.5%
2/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
2.1%
3/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
2.2%
3/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Infections and infestations
Urinary Tract Infection
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
1.5%
2/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
2.1%
3/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.74%
1/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
2.1%
3/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
1.5%
2/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Injury, poisoning and procedural complications
Laceration
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.73%
1/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.71%
1/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Investigations
Alanine Aminotransferase Increased
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.73%
1/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Investigations
Aspartate Aminotransferase Increased
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.73%
1/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.73%
1/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
10.0%
2/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.73%
1/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.71%
1/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Investigations
Blood Insulin Decreased
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.73%
1/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Investigations
Electrocardiogram QT Prolonged
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
2.2%
3/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
1.4%
2/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.74%
1/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Investigations
Protein Total Decreased
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Metabolism and nutrition disorders
Vitamin B12 Deficiency
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.73%
1/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
5.7%
8/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
3.0%
4/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
8.8%
12/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
9.3%
13/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
8.1%
11/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Psychiatric disorders
Agitation
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
1.5%
2/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
2.9%
4/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
3.0%
4/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
5.1%
7/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
5.7%
8/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
4.4%
6/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Psychiatric disorders
Paranoia
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.74%
1/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.71%
1/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.73%
1/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
2.2%
3/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
|
Vascular disorders
Orthostatic Hypotension
|
5.0%
1/20 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/137 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.71%
1/140 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
0.00%
0/135 • Adverse events (AEs) were collected throughout the study (Baseline to Week 12/ET).
Only participants who received at least 1 dose of study drug were analyzed for safety (Placebo N=135).
|
Additional Information
Global Clinical Development
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phone: 1-609-524-6788
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right to review results publications prior to public release and can delay such publications for a period greater than 60 days but no more than 120 days from the date that the publication is submitted to the Sponsor for review. Sponsor can require changes to the publication to protect Sponsor's intellectual property rights and/or confidential information and reserves the right to limit publication timing and scope of data published based on the number of study locations.
- Publication restrictions are in place
Restriction type: OTHER