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

Alcohol Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01218971
• Other study ID #: ALK21-003-EXT
• Status: Completed
• Phase: Phase 3
• First received: October 8, 2010
• Last updated: December 8, 2010
• Start date: August 2002
• Est. completion date: September 2004

Study information

• Verified date: December 2010
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: September 2004
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• Medisorb naltrexone 190 mg
naltrexone for extended-release injectable suspension
• Medisorb naltrexone 380 mg
naltrexone for extended-release injectable suspension

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No