At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 210 enrolled
Drug / intervention
Brexpiprazoledrug
Likely dose
Brexpiprazole 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Interventional, Open-label, Flexible-dose Extension Study of Brexpiprazole in Patients With Schizophrenia
In Brief
A Phase 3 clinical trial evaluating Brexpiprazole for Schizophrenia. Completed, enrolled 210 participants across 48 sites in 8 countries.
Detailed Summary
To determine the safety and efficacy of brexpiprazole during long-term treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesEstonia, Poland, Romania, Russia, Serbia, Slovakia, Ukraine, United States
CollaboratorsOtsuka Pharmaceutical Co., Ltd.
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 2013
Enrollment StartJul 2013
Primary CompletionDec 2015
TodayJul 2026
First PostedMar 14, 2013
Enrollment StartJul 1, 2013
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 13.3 years ago
Interventions
Brexpiprazoledrug
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).