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

Information source: Alkermes, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alcoholism

Intervention: Medisorb naltrexone 380 mg (Drug); Medisorb naltrexone 190 mg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Alkermes, Inc.

Official(s) and/or principal investigator(s):
Bernard L. Silverman, MD, Study Director, Affiliation: Alkermes, Inc.

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®).

Clinical Details

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

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

Primary outcome: Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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)

Locations and Contacts

Additional Information

Starting date: October 2003
Last updated: December 7, 2010

Page last updated: August 23, 2015

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