NCT00156923

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

A Multi-Center Extension of Alkermes' Study ALK21-003-EXT (NCT01218971) to Evaluate the Long-Term Safety of Medisorb® Naltrexone

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Alkermes, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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®).

Detailed description

Enrolled subjects continued to receive the same dose strength of Medisorb naltrexone (ie, 190 mg or 380 mg) they had received in Study ALK21-003-EXT (NCT01218971). Assigned dose strength (high or low) was not revealed to the subject, the study investigators, or any blinded member of the clinical study team for the duration of the study period. Placebo was not administered.

Conditions

• Alcoholism

Interventions

Type	Name	Description
DRUG	Medisorb naltrexone 380 mg	Administered via intramuscular (IM) injection once every 4 weeks for up to 3.5 years.
DRUG	Medisorb naltrexone 190 mg	Administered via IM injection once every 4 weeks for up to 3.5 years.

Timeline

• Start date: 2003-10-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2005-09-12
• Last updated: 2017-07-11
• Results posted: 2010-12-03