ALK21-003EXT: An Extension of Study ALK21-003 (NCT01218958) to Test the Long-term Safety of Medisorb® Naltrexone (VIVITROL®)
A Multicenter Double-Blind Extension of Alkermes Study ALK21-003 to Evaluate the Long-Term Safety of Medisorb® Naltrexone
1 other identifier
interventional
332
0 countries
N/A
Brief Summary
This was a Phase 3 multicenter extension of Alkermes' Study ALK21-003 (NCT01218958 \[the base study\]) that evaluated the safety of Medisorb® naltrexone (VIVITROL®) administered every 4 weeks for 48 weeks (13 injections) in alcohol-dependent adults who had completed Study ALK21-003.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2002
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 8, 2010
CompletedFirst Posted
Study publicly available on registry
October 13, 2010
CompletedResults Posted
Study results publicly available
December 8, 2010
CompletedDecember 24, 2010
December 1, 2010
2.1 years
October 8, 2010
November 8, 2010
December 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study
A TEAE is any adverse event, whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).
Up to 48 weeks (13 injections), not including base study
Study Arms (2)
Medisorb naltrexone 380 mg
EXPERIMENTALIntramuscular (IM) injection administered once every 4 weeks for up to 48 weeks.
Medisorb naltrexone 190 mg
EXPERIMENTALIM injection administered once every 4 weeks for up to 48 weeks.
Interventions
naltrexone for extended-release injectable suspension
naltrexone for extended-release injectable suspension
Eligibility Criteria
You may qualify if:
- Completed study drug treatment in Study ALK21-003 (base study \[NCT01218958\])
- Written informed consent for this extension study
- Stable address and telephone; reconfirmation of contact's address and phone
- Women with childbearing potential must agree to continue to use an approved method of birth control throughout study participation
You may not qualify if:
- Positive urine drug screen for opioids at Visit 1
- Early termination of study drug in the base study
- Pregnancy or lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alkermes, Inc.lead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bernard L. Silverman, MD
- 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
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 8, 2010
First Posted
October 13, 2010
Study Start
August 1, 2002
Primary Completion
September 1, 2004
Study Completion
September 1, 2004
Last Updated
December 24, 2010
Results First Posted
December 8, 2010
Record last verified: 2010-12