CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 108 enrolled
Drug / intervention
Medisorb naltrexone 380 mg +1 moredrug
Likely dose
Medisorb naltrexone 380 mg or 190 mg via intramuscular injection once every 4 weeksAI-extracted
Key inclusion· 4
  • ✓Completed prior Study ALK21-003-EXT (NCT01218971) and received all 13 injections
  • ✓Willing and able to return for scheduled clinic visits and study assessments
  • ✓Noncustodial and with stable address and phone contact
  • ✓Written informed consent provided
Key exclusion· 2
  • ✕Pregnancy or lactation
  • ✕Terminated early from study drug in prior Study ALK21-003-EXT (NCT01218971)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00156923
NCT00156923Phase 3Completed
CompareCT.gov

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

Alkermes, Inc.·interventional·Posted Sep 12, 2005·Updated Jul 11, 2017

In Brief

A Phase 3 clinical trial evaluating Medisorb naltrexone 380 mg and Medisorb naltrexone 190 mg for Alcoholism. Completed, enrolled 108 participants.

Detailed 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®).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcoholism
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2005
Enrollment StartOct 1, 2003
Primary CompletionJan 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 20.8 years ago

Interventions

Medisorb naltrexone 380 mgdrug

Administered via intramuscular (IM) injection once every 4 weeks for up to 3.5 years.

Medisorb naltrexone 190 mgdrug

Administered via IM injection once every 4 weeks for up to 3.5 years.