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

Phase 3

Completed

• Conditions: Alcohol Dependence
• Interventions: Drug: Medisorb naltrexone 380 mg; Drug: Medisorb naltrexone 190 mg

• Registration Number: NCT01218971
• Lead Sponsor: Alkermes, Inc.

Brief 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.

Detailed Description

All participants in this study received Medisorb naltrexone at double-blinded dose strengths (ie, 190 mg or 380 mg); no participant received placebo. Participants who had received Medisorb naltrexone in Study ALK21-003 (NCT01218958) continued to receive the same dose strength in this extension study. Those who had received placebo for Medisorb naltrexone 190 mg in the base study were given Medisorb naltrexone 190 mg. Participants who had received placebo for Medisorb naltrexone 380 mg in the base study were given Medisorb naltrexone 380 mg.

Neither the identity or dose of the treatment received in the base study, nor the Medisorb naltrexone dose strength (190 mg or 380 mg) received in this extension were revealed to any participant, the investigator, or any blinded member of the clinical study team during the conduct of the base study or this extension.

All participants were encouraged to receive standardized biopsychosocial support at each clinic visit throughout the study; however, unlike the base study, participation was not mandatory.

Participants eligible for this extension study had received all 6 injections of study drug in the base study; those who received Medisorb naltrexone in the base study who also received all 13 injections in this extension therefore had a duration of exposure of approximately 76 weeks (\~1.5 years) upon completion of this extension. For participants who had received placebo in the base study, maximum duration of exposure was approx. 48 weeks (1 year).

Study Timeline

• Study Start: 2002-08
• Primary Completion: 2004-09
• Study Completion: 2004-09
• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-13
• Results First Submitted: 2010-11-08
• Results First Submitted QC: 2010-11-08
• Status Verified: 2010-12
• Results First Posted: 2010-12-08
• Last Update Submitted: 2010-12-08
• Last Update Posted: 2010-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 332

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medisorb naltrexone 380 mg	Medisorb naltrexone 380 mg	Intramuscular (IM) injection administered once every 4 weeks for up to 48 weeks.
Medisorb naltrexone 190 mg	Medisorb naltrexone 190 mg	IM injection administered once every 4 weeks for up to 48 weeks.

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study	Up to 48 weeks (13 injections), not including base study	A TEAE is any adverse event, whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).