ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults
A Multi-Center Extension of Alkermes' Study ALK21-003-EXT (NCT01218971) to Evaluate the Long-Term Safety of Medisorb® Naltrexone
1 other identifier
interventional
108
0 countries
N/A
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®).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2003
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedResults Posted
Study results publicly available
December 3, 2010
CompletedJuly 11, 2017
June 1, 2017
3.3 years
September 7, 2005
October 8, 2010
June 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Up to 3.5 years of monthly treatment
Study Arms (2)
Medisorb naltrexone 380 mg
EXPERIMENTALMedisorb naltrexone 190 mg
EXPERIMENTALInterventions
Administered via intramuscular (IM) injection once every 4 weeks for up to 3.5 years.
Administered via IM injection once every 4 weeks for up to 3.5 years.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy or lactation
- Terminated early from study drug in Study ALK21-003-EXT (NCT01218971)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alkermes, Inc.lead
Related Publications (1)
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.
PMID: 21314752RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bernard L. Silverman / VP, Clinical Development
- Organization
- Alkermes, Inc.
Study Officials
- STUDY DIRECTOR
Bernard L. Silverman, MD
Alkermes, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 12, 2005
Study Start
October 1, 2003
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
July 11, 2017
Results First Posted
December 3, 2010
Record last verified: 2017-06