At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 403 enrolled
Drug / intervention
ALK3831 +2 moredrug
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 Phase 3 Study to Determine the Antipsychotic Efficacy and Safety of ALKS 3831 in Adult Subjects With Acute Exacerbation of Schizophrenia
In Brief
A Phase 3 clinical trial evaluating ALK3831, Olanzapine, and 1 other intervention for Schizophrenia. Completed, enrolled 403 participants across 31 sites in 4 countries.
Detailed Summary
This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation of schizophrenia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesBulgaria, Serbia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartDec 2015
First PostedDec 2015
Primary CompletionMay 2017
Study CompletionJun 2017
TodayJul 2026
First PostedDec 18, 2015
Enrollment StartDec 1, 2015
Primary CompletionMay 25, 2017
Study CompletionJun 7, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.5 years ago
Interventions
ALK3831drug
Daily dosing
Olanzapinedrug
Daily dosing
Placebodrug
Daily dosing