A Multi-Center Extension of Alkermes' Study ALK21-003-EXT (NCT01218971) to Evaluate the Long-Term Safety of Medisorb® Naltrexone
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Alkermes, Inc.
- Enrollment
- 108
- Primary Endpoint
- Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)
Study Overview
Brief 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®).
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- •Pregnancy or lactation
- •Terminated early from study drug in Study ALK21-003-EXT (NCT01218971)
Arms & Interventions
Medisorb naltrexone 380 mg
Intervention: Medisorb naltrexone 380 mg (Drug)
Medisorb naltrexone 190 mg
Intervention: Medisorb naltrexone 190 mg (Drug)
Outcomes
Primary Outcomes
Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)
Time Frame: Up to 3.5 years of monthly treatment
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).
Secondary Outcomes
No secondary outcomes reported