A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

• Status: Completed
• Trial end date: 2018-06-29
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the long term safety and tolerability of ALKS 3831 in subjects with schizophrenia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkermes, Inc.

Criteria

Inclusion Criteria:

• Subject has completed the 4-week treatment period (all visits up to and including end of treatment visit) in the antecedent study ALK3831-A305 within 7 days.

• Agrees to use an acceptable method of contraception for the duration of the study.

• Additional criteria may apply.

Exclusion Criteria:

• Subject is currently taking medications that are contraindicated with olanzapine use.

• 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.