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, Inc.
ClinicalTrials.gov Identifier:
NCT01218971
First received: October 8, 2010
Last updated: December 8, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Alcohol Dependence
Drug: Medisorb naltrexone 190 mg
Drug: Medisorb naltrexone 380 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter Double-Blind Extension of Alkermes Study ALK21-003 to Evaluate the Long-Term Safety of Medisorb® Naltrexone

Resource links provided by NLM:


Further study details as provided by Alkermes, Inc.:

Primary Outcome Measures:
  • 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).


Enrollment: 332
Study Start Date: August 2002
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Medisorb naltrexone 380 mg
Intramuscular (IM) injection administered once every 4 weeks for up to 48 weeks.
Drug: Medisorb naltrexone 380 mg
naltrexone for extended-release injectable suspension
Other Name: VIVITROL
Experimental: Medisorb naltrexone 190 mg
IM injection administered once every 4 weeks for up to 48 weeks.
Drug: Medisorb naltrexone 190 mg
naltrexone for extended-release injectable suspension

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01218971

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

No publications provided

Responsible Party: Bernard Silverman, MD / Vice President, Clinical Development, Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT01218971     History of Changes
Other Study ID Numbers: ALK21-003-EXT
Study First Received: October 8, 2010
Results First Received: November 8, 2010
Last Updated: December 8, 2010
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014