At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 291 enrolled
Drug / intervention
ALKS 9072, Low Dose +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.
A Phase 3, Multicenter Extension of Study ALK9072-003EXT to Assess the Long-term Safety and Durability of Effect of ALKS 9072 in Subjects With Stable Schizophrenia
In Brief
A Phase 3 clinical trial evaluating ALKS 9072, Low Dose and ALKS 9072, High Dose for Schizophrenia. Completed, enrolled 291 participants across 57 sites in 8 countries.
Detailed Summary
This is an extension of a previous study (ALK9072-003EXT). The purpose of this study is to continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesBulgaria, Malaysia, Philippines, Romania, Russia, South Korea, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJul 2013
First PostedJul 2013
Primary CompletionJun 2016
TodayJul 2026
First PostedJul 10, 2013
Enrollment StartJul 1, 2013
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 13.0 years ago
Interventions
ALKS 9072, Low Dosedrug
Intramuscular injection, given monthly
ALKS 9072, High Dosedrug
Intramuscular injection, given monthly