At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 381 enrolled
Drug / intervention
Brexpiprazoledrug
Likely dose
Not stated in 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.
A Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Bipolar I Disorder
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Sep 19, 2017·Updated Aug 17, 2020
In Brief
A Phase 3 clinical trial evaluating Brexpiprazole for Bipolar I Disorder and Acute Mania. Completed, enrolled 381 participants across 73 sites in 6 countries.
Detailed Summary
This study evaluated the safety and evaluate the safety and tolerability of open-label brexpiprazole (2 - 4 mg/day, with a starting dose of 2 mg/day) for the treatment of adult subjects with bipolar I disorder. All participants received a starting dose of brexpiprazole.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar I Disorder, Acute Mania
CountriesBulgaria, Croatia, Poland, Serbia, Ukraine, United States
CollaboratorsH. Lundbeck A/S
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedSep 2017
Enrollment StartOct 2017
Primary CompletionJul 2019
TodayJul 2026
First PostedSep 19, 2017
Enrollment StartOct 24, 2017
Primary CompletionJul 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.8 years ago
Interventions
Brexpiprazoledrug
Brexpiprazole tablets