ALK21-003EXT: An Extension of Study ALK21-003 (NCT01218958) to Test the Long-term Safety of Medisorb® Naltrexone (VIVITROL®)

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This was a Phase 3 multicenter extension of Alkermes' Study ALK21-003 (NCT01218958 [the base study]) that evaluated the safety of Medisorb® naltrexone (VIVITROL®) administered every 4 weeks for 48 weeks (13 injections) in alcohol-dependent adults who had completed Study ALK21-003.

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

Details

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

Criteria

Primary Inclusion Criteria:

• Completed study drug treatment in Study ALK21-003 (base study [NCT01218958])

• Written informed consent for this extension study

• Stable address and telephone; reconfirmation of contact's address and phone

• Women with childbearing potential must agree to continue to use an approved method of birth control throughout study participation

Primary Exclusion Criteria:

• Positive urine drug screen for opioids at Visit 1

• Early termination of study drug in the base study

• Pregnancy or lactation