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

This study has been completed.
Sponsor:
Information provided by:
Alkermes
ClinicalTrials.gov Identifier:
NCT00156923
First received: September 7, 2005
Last updated: December 7, 2010
Last verified: December 2010
  Purpose

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®).


Condition Intervention Phase
Alcoholism
Drug: Medisorb naltrexone 380 mg
Drug: Medisorb naltrexone 190 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center Extension of Alkermes' Study ALK21-003-EXT (NCT01218971) to Evaluate the Long-Term Safety of Medisorb® Naltrexone

Resource links provided by NLM:


Further study details as provided by Alkermes:

Primary Outcome Measures:
  • Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) [ Time Frame: Up to 3.5 years of monthly treatment ] [ Designated as safety issue: No ]
    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).


Enrollment: 108
Study Start Date: October 2003
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medisorb naltrexone 380 mg Drug: Medisorb naltrexone 380 mg
Administered via intramuscular (IM) injection once every 4 weeks for up to 3.5 years.
Other Names:
  • VIVITROL® 380 mg
  • Naltrexone for extended-release injectable suspension
Experimental: Medisorb naltrexone 190 mg Drug: Medisorb naltrexone 190 mg
Administered via IM injection once every 4 weeks for up to 3.5 years.
Other Name: Naltrexone for extended-release injectable suspension

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156923

Sponsors and Collaborators
Alkermes
Investigators
Study Director: Bernard L. Silverman, MD Alkermes
  More Information

No publications provided

Responsible Party: Bernard L. Silverman, MD / VP, Clinical Development, Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT00156923     History of Changes
Other Study ID Numbers: ALK21-010
Study First Received: September 7, 2005
Results First Received: October 8, 2010
Last Updated: December 7, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Alkermes:
Alcohol dependence

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014