ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone (VIVITROL®).

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

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: Naltrexone

Criteria

Primary Inclusion Criteria:

• Completed Study ALK21-003-EXT (NCT01218971), receiving all 13 injections

• Willing and able to return for scheduled clinic visits and study assessments

• Noncustodial, stable address and phone

• Written, informed consent

Primary Exclusion Criteria:

• Pregnancy or lactation

• Terminated early from study drug in Study ALK21-003-EXT (NCT01218971)