A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia
- Registration Number
- NCT02873208
- Lead Sponsor
- Alkermes, Inc.
- Brief Summary
The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 3831 in subjects with schizophrenia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 266
Inclusion Criteria
- Agrees to use an acceptable method of contraception for the duration of the study
- Subject has completed the 24-week treatment period in the antecedent study, ALK3831-A303, within 7 days
- Additional criteria may apply
Exclusion Criteria
- Subject is currently taking medications that are contraindicated with olanzapine use or exhibit drug-interaction potential with olanzapine
- Subject has a positive test for drugs of abuse at study entry
- Subject is pregnant, planning to become pregnant, or breastfeeding during the study
- Additional criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ALKS 3831 ALKS 3831 Oral tablet, daily dosing
- Primary Outcome Measures
Name Time Method Number of Subjects With Adverse Events Up to 52 weeks Overall summary of treatment emergent adverse events during the treatment period
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Alkermes Investigational Site
🇵🇷San Juan, Puerto Rico