CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 523 enrolled
Drug / intervention
ALKS 3831drug
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.

Search/NCT03201757
NCT03201757Phase 3Completed
CompareCT.gov

A Phase 3 Study to Assess the Long Term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 in Subjects With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder

Alkermes, Inc.·interventional·Posted Jun 28, 2017·Updated Sep 26, 2024

In Brief

A Phase 3 clinical trial evaluating ALKS 3831 for Schizophrenia and 2 related conditions. Completed, enrolled 523 participants across 85 sites in 13 countries.

Detailed Summary

This study will evaluate the long-term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Schizophreniform Disorder, Bipolar I Disorder
CountriesAustria, Bulgaria, Ireland, Israel, Italy, Poland, Puerto Rico, Russia, Serbia, South Korea, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJun 28, 2017
Enrollment StartJun 15, 2017
Primary CompletionSep 6, 2023
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 9.0 years ago

Interventions

ALKS 3831drug

Olanzapine + samidorphan, daily oral dosing