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
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