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

Alcoholism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00156923
• Other study ID #: ALK21-010
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: December 7, 2010
• Start date: October 2003
• Est. completion date: January 2007

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, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone (VIVITROL®).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Primary Inclusion Criteria:

• Completed Study ALK21-003-EXT (NCT01218971), receiving all 13 injections

• Willing and able to return for scheduled clinic visits and study assessments

• Noncustodial, stable address and phone

• Written, informed consent

Primary Exclusion Criteria:

• Pregnancy or lactation

• Terminated early from study drug in Study ALK21-003-EXT (NCT01218971)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• Medisorb naltrexone 380 mg
Administered via intramuscular (IM) injection once every 4 weeks for up to 3.5 years.
• Medisorb naltrexone 190 mg
Administered via IM injection once every 4 weeks for up to 3.5 years.

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)	A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration in this extension through the end of the follow-up period).	Up to 3.5 years of monthly treatment	No

External Links

•   WHO International Clinical Trials registry platform search portal