Phase 3
Completed N=108
ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults
Alcoholism
Source: ClinicalTrials.gov NCT00156923 ↗
Enrolled (actual)
108
Serious AEs
16.7%
Results posted
Dec 2010
Primary outcomePrimary: Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) — 49; 51 Participants
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®).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) |
49; 51 | — |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00156923). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.