A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

• Status: Completed
• Trial end date: 2019-10-17
• 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:

• 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