Back to resultsALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults
Primary Purpose
Alcoholism
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Medisorb naltrexone 380 mg
Medisorb naltrexone 190 mg
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholism focused on measuring Alcohol dependence
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Medisorb naltrexone 380 mg
Medisorb naltrexone 190 mg
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)
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 Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00156923
Brief Title
ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults
Official Title
A Multi-Center Extension of Alkermes' Study ALK21-003-EXT (NCT01218971) to Evaluate the Long-Term Safety of Medisorb® Naltrexone
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Alkermes, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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®).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
Alcohol dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medisorb naltrexone 380 mg
Arm Type
Experimental
Arm Title
Medisorb naltrexone 190 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Medisorb naltrexone 380 mg
Other Intervention Name(s)
VIVITROL® 380 mg, Naltrexone for extended-release injectable suspension
Intervention Description
Administered via intramuscular (IM) injection once every 4 weeks for up to 3.5 years.
Intervention Type
Drug
Intervention Name(s)
Medisorb naltrexone 190 mg
Other Intervention Name(s)
Naltrexone for extended-release injectable suspension
Intervention Description
Administered via IM injection once every 4 weeks for up to 3.5 years.
Primary Outcome Measure Information:
Title
Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)
Description
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).
Time Frame
Up to 3.5 years of monthly treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard L. Silverman, MD
Organizational Affiliation
Alkermes, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
21314752
Citation
O'Brien CP, Gastfriend DR, Forman RF, Schweizer E, Pettinati HM. Long-term opioid blockade and hedonic response: preliminary data from two open-label extension studies with extended-release naltrexone. Am J Addict. 2011 Mar-Apr;20(2):106-12. doi: 10.1111/j.1521-0391.2010.00107.x. Epub 2010 Dec 28.
Results Reference
result
Links:
URL
http://apps.who.int/trialsearch/trial.aspx?trialid=NCT00156923
Description
WHO International Clinical Trials registry platform search portal
Learn more about this trial
ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults
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