ALK21-003EXT: An Extension of Study ALK21-003 (NCT01218958) to Test the Long-term Safety of Medisorb® Naltrexone (VIVITROL®)

This study has been completed.
Sponsor:
Information provided by:
Alkermes
ClinicalTrials.gov Identifier:
NCT01218971
First received: October 8, 2010
Last updated: December 8, 2010
Last verified: December 2010

October 8, 2010
December 8, 2010
August 2002
September 2004   (final data collection date for primary outcome measure)
Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study [ Time Frame: Up to 48 weeks (13 injections), not including base study ] [ Designated as safety issue: No ]
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).
To evaluate the long-term safety of repeated intramuscular (IM) injections of Medisorb naltrexone administered every 4 weeks to alcohol-dependent adults. [ Time Frame: Up to 48 weeks (13 injections), not including base study ] [ Designated as safety issue: No ]
Number of subjects reporting at least 1 treatment-emergent adverse event (TEAE) while on study.
Complete list of historical versions of study NCT01218971 on ClinicalTrials.gov Archive Site
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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

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.

All participants in this study received Medisorb naltrexone at double-blinded dose strengths (ie, 190 mg or 380 mg); no participant received placebo. Participants who had received Medisorb naltrexone in Study ALK21-003 (NCT01218958) continued to receive the same dose strength in this extension study. Those who had received placebo for Medisorb naltrexone 190 mg in the base study were given Medisorb naltrexone 190 mg. Participants who had received placebo for Medisorb naltrexone 380 mg in the base study were given Medisorb naltrexone 380 mg.

Neither the identity or dose of the treatment received in the base study, nor the Medisorb naltrexone dose strength (190 mg or 380 mg) received in this extension were revealed to any participant, the investigator, or any blinded member of the clinical study team during the conduct of the base study or this extension.

All participants were encouraged to receive standardized biopsychosocial support at each clinic visit throughout the study; however, unlike the base study, participation was not mandatory.

Participants eligible for this extension study had received all 6 injections of study drug in the base study; those who received Medisorb naltrexone in the base study who also received all 13 injections in this extension therefore had a duration of exposure of approximately 76 weeks (~1.5 years) upon completion of this extension. For participants who had received placebo in the base study, maximum duration of exposure was approx. 48 weeks (1 year).

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alcohol Dependence
  • Drug: Medisorb naltrexone 190 mg
    naltrexone for extended-release injectable suspension
  • Drug: Medisorb naltrexone 380 mg
    naltrexone for extended-release injectable suspension
    Other Name: VIVITROL
  • Experimental: Medisorb naltrexone 380 mg
    Intramuscular (IM) injection administered once every 4 weeks for up to 48 weeks.
    Intervention: Drug: Medisorb naltrexone 380 mg
  • Experimental: Medisorb naltrexone 190 mg
    IM injection administered once every 4 weeks for up to 48 weeks.
    Intervention: Drug: Medisorb naltrexone 190 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
332
September 2004
September 2004   (final data collection date for primary outcome measure)

Primary Inclusion Criteria:

  • 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

Primary Exclusion Criteria:

  • Positive urine drug screen for opioids at Visit 1
  • Early termination of study drug in the base study
  • Pregnancy or lactation
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01218971
ALK21-003-EXT
No
Bernard Silverman, MD / Vice President, Clinical Development, Alkermes, Inc.
Alkermes
Not Provided
Study Director: Bernard L Silverman, MD Alkermes
Alkermes
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP