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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00156923
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : December 3, 2010
Last Update Posted : July 11, 2017
Sponsor:
Information provided by:

Study Description
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®).

Condition or disease Intervention/treatment Phase
Alcoholism Drug: Medisorb naltrexone 380 mg Drug: Medisorb naltrexone 190 mg Phase 3

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  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2003
Primary Completion Date : January 2007
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00156923


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

Additional Information:
Publications:
Responsible Party: Bernard L. Silverman, MD / VP, Clinical Development, Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT00156923     History of Changes
Other Study ID Numbers: ALK21-010
First Posted: September 12, 2005    Key Record Dates
Results First Posted: December 3, 2010
Last Update Posted: July 11, 2017
Last Verified: June 2017

Keywords provided by Alkermes, Inc.:
Alcohol dependence

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents