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Clinical trial

A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)

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Last updated:1st Dec 2015

This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation of schizophrenia.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Study to Determine the Antipsychotic Efficacy and Safety of ALKS 3831 in Adult Subjects With Acute Exacerbation of Schizophrenia
Estimated Enrollment: 390
Study Start Date: December 2015
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
ALKS 3831
- Active Comparator: Olanzapine
- Placebo Comparator: Placebo

Category Value
Study start date 2015-12-01

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