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

A Multicenter Double-Blind Extension of Alkermes Study ALK21-003 to Evaluate the Long-Term Safety of Medisorb® Naltrexone

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Dependence
• Intervention / Treatment: Drug: Medisorb naltrexone 380 mg; Drug: Medisorb naltrexone 190 mg

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 Type: Interventional
• Enrollment (Actual): 332
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medisorb naltrexone 380 mg; Intramuscular (IM) injection administered once every 4 weeks for up to 48 weeks.	Drug: Medisorb naltrexone 380 mg; naltrexone for extended-release injectable suspension; Other Names: VIVITROL
Experimental: Medisorb naltrexone 190 mg; IM injection administered once every 4 weeks for up to 48 weeks.	Drug: Medisorb naltrexone 190 mg; naltrexone for extended-release injectable suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in 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).	Up to 48 weeks (13 injections), not including base study

Collaborators and Investigators

• Sponsor: Alkermes, Inc.
• Investigators: Study Director: Bernard L Silverman, MD, Alkermes, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2002
• Primary Completion (Actual): September 1, 2004
• Study Completion (Actual): September 1, 2004

Study Registration Dates

• First Submitted: October 8, 2010
• First Submitted That Met QC Criteria: October 8, 2010
• First Posted (Estimate): October 13, 2010

Study Record Updates

• Last Update Posted (Estimate): December 24, 2010
• Last Update Submitted That Met QC Criteria: December 8, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Alcohol Dependence
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone
• Other Study ID Numbers: ALK21-003-EXT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No