Trial Outcomes & Findings for Brexpiprazole in Patients With Schizophrenia (NCT NCT01810783)
NCT ID: NCT01810783
Last Updated: 2017-03-27
Results Overview
Number of treatment-emergent adverse events (TEAEs)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
210 participants
Primary outcome timeframe
Up to 52 weeks and a safety follow-up by telephone contact or clinic visit after 30 days after the last dose of investigational medicinal product (IMP)
Results posted on
2017-03-27
Participant Flow
Participant milestones
| Measure |
Brexpiprazole
Brexpiprazole: 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
|
|---|---|
|
Overall Study
STARTED
|
210
|
|
Overall Study
COMPLETED
|
101
|
|
Overall Study
NOT COMPLETED
|
109
|
Reasons for withdrawal
| Measure |
Brexpiprazole
Brexpiprazole: 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
|
|---|---|
|
Overall Study
Adverse Event
|
32
|
|
Overall Study
Withdrawal by Subject
|
22
|
|
Overall Study
Lack of Efficacy
|
12
|
|
Overall Study
Lost to Follow-up
|
10
|
|
Overall Study
Protocol Violation
|
5
|
|
Overall Study
Non-compliance with IMP
|
4
|
|
Overall Study
Adminstrative or other reason(s)
|
23
|
|
Overall Study
Enrolled, not treated
|
1
|
Baseline Characteristics
Brexpiprazole in Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
Brexpiprazole
n=210 Participants
Brexpiprazole: 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
208 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
40.89 years
STANDARD_DEVIATION 11.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
113 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
64 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Serbia
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
52 participants
n=5 Participants
|
|
Region of Enrollment
Estonia
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 52 weeks and a safety follow-up by telephone contact or clinic visit after 30 days after the last dose of investigational medicinal product (IMP)Population: 210 patients were enrolled, only 209 patients were treated with brexpiprazole.TAES is based on these 209 patients
Number of treatment-emergent adverse events (TEAEs)
Outcome measures
| Measure |
Brexpiprazole
n=209 Participants
Brexpiprazole: 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
|
|---|---|
|
Safety and Tolerability
|
337 TEAEs
|
Adverse Events
Brexpiprazole
Serious events: 31 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brexpiprazole
n=209 participants at risk
210 were enrolled, only 209 patients were treated with brexpiprazole
|
|---|---|
|
Gastrointestinal disorders
Colitis
|
0.48%
1/209 • Baseline to end of study
|
|
Infections and infestations
Peritonsillar abscess
|
0.48%
1/209 • Baseline to end of study
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.48%
1/209 • Baseline to end of study
|
|
Investigations
Alanine aminotransferase increased
|
0.48%
1/209 • Baseline to end of study
|
|
Investigations
Aspartate aminotransferase increased
|
0.48%
1/209 • Baseline to end of study
|
|
Investigations
Blood bilirubin increased
|
0.48%
1/209 • Baseline to end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage iv
|
0.48%
1/209 • Baseline to end of study
|
|
Nervous system disorders
Grand mal convulsion
|
0.48%
1/209 • Baseline to end of study
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.89%
1/112 • Baseline to end of study
|
|
Psychiatric disorders
Aggression
|
0.48%
1/209 • Baseline to end of study
|
|
Psychiatric disorders
Panic attack
|
0.48%
1/209 • Baseline to end of study
|
|
Psychiatric disorders
Psychotic disorder
|
0.96%
2/209 • Baseline to end of study
|
|
Psychiatric disorders
Schizophrenia
|
8.6%
18/209 • Baseline to end of study
|
|
Psychiatric disorders
Suicidal ideation
|
0.96%
2/209 • Baseline to end of study
|
|
Psychiatric disorders
Suicide attempt
|
0.48%
1/209 • Baseline to end of study
|
|
Renal and urinary disorders
Urinary retention
|
0.48%
1/209 • Baseline to end of study
|
|
Social circumstances
Social stay hospitalisation
|
0.96%
2/209 • Baseline to end of study
|
Other adverse events
| Measure |
Brexpiprazole
n=209 participants at risk
210 were enrolled, only 209 patients were treated with brexpiprazole
|
|---|---|
|
Investigations
Weight increased
|
10.5%
22/209 • Baseline to end of study
|
|
Nervous system disorders
Headache
|
8.6%
18/209 • Baseline to end of study
|
|
Psychiatric disorders
Insomnia
|
8.1%
17/209 • Baseline to end of study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place