CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 478 enrolled
Drug / intervention
ALKS 9072, Low +1 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.

Search/NCT01626456
NCT01626456Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Extension of Study ALK9072-003 to Assess the Long-term Safety and Durability of Effect of ALKS 9072 in Subjects With Stable Schizophrenia

Alkermes, Inc.·interventional·Posted Jun 22, 2012·Updated Sep 25, 2018

In Brief

A Phase 3 clinical trial evaluating ALKS 9072, Low and ALKS 9072, High for Schizophrenia. Completed, enrolled 478 participants across 82 sites in 8 countries.

Detailed Summary

This study will evaluate the safety and durability of effect of ALKS 9072 (also known as ALKS 9070) during long-term treatment of subjects with stable schizophrenia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesBulgaria, Malaysia, Philippines, Romania, Russia, South Korea, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 22, 2012
Enrollment StartJun 1, 2012
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.0 years ago

Interventions

ALKS 9072, Lowdrug

IM injection, given monthly

ALKS 9072, Highdrug

IM injection, given monthly