At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 623 enrolled
Drug / intervention
ALKS 9072 +1 moredrug
Likely dose
ALKS 9072 441 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 Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of ALKS 9072 in Subjects With Acute Exacerbation of Schizophrenia
In Brief
A Phase 3 clinical trial evaluating ALKS 9072 and Placebo for Schizophrenia. Completed, enrolled 623 participants across 84 sites in 8 countries.
Detailed Summary
The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesBulgaria, Malaysia, Philippines, Romania, Russia, South Korea, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 2011
Enrollment StartDec 2011
Primary CompletionJan 2014
Study CompletionMar 2014
TodayJul 2026
First PostedNov 10, 2011
Enrollment StartDec 1, 2011
Primary CompletionJan 1, 2014
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 14.6 years ago
Interventions
ALKS 9072drug
Intramuscular (IM) injection, 441 mg or 882 mg given monthly
Placebodrug
Placebo for IM injection, given monthly