At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 157 enrolled
Drug / intervention
SEP-363856drug
Likely dose
SEP-363856 25 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.
A 26-Week Open-label Safety and Tolerability Extension Study of SEP-363856 in Adult Subjects With Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Nov 22, 2016·Updated Jul 5, 2024
In Brief
A Phase 2 clinical trial evaluating SEP-363856 for Schizophrenia. Completed, enrolled 157 participants across 30 sites in 5 countries.
Detailed Summary
An extension study of safety and tolerability of SEP-363856 in adult subjects with schizophrenia
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesHungary, Romania, Russia, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2016
Enrollment StartJan 2017
Primary CompletionJan 2019
TodayJul 2026
First PostedNov 22, 2016
Enrollment StartJan 31, 2017
Primary CompletionJan 29, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 9.6 years ago
Interventions
SEP-363856drug
One SEP-363856 capsule (25 mg, 50 mg or 75 mg (flex)) daily for 26 weeks