ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])
This was a multicenter extension of Alkermes' Study ALK21-006 (NCT01218997) designed to assess the long-term safety of repeat monthly doses of naltrexone long-acting injection. All subjects received open-label Medisorb® naltrexone 380 mg (VIVITROL®).
Planned treatment duration was up to 3 years. Alkermes terminated the study for business purposes in December 2006. The median duration of treatment among all subjects in this extension study was 43 weeks.
|Alcoholism Opiate Dependence||Drug: Medisorb naltrexone 380 mg Drug: Oral naltrexone to Medisorb naltrexone 380 mg||Phase 3|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Multi-Center Study to Evaluate the Long-Term Safety of Medisorb® Naltrexone|
- Number of Subjects Who Reported at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study. [ Time Frame: Up to 3 years ]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 through the end of the follow-up period).
|Study Start Date:||August 2004|
|Study Completion Date:||January 2007|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
|Experimental: Medisorb naltrexone 380 mg (VIVITROL)||
Drug: Medisorb naltrexone 380 mg
Administered via intramuscular (IM) injection once every 4 weeks. Subjects in this dosing group also received this treatment throughout the base study.
|Experimental: Oral naltrexone to Medisorb naltrexone 380 mg (VIVITROL)||
Drug: Oral naltrexone to Medisorb naltrexone 380 mg
Subjects in this dosing group received oral naltrexone 50 mg in the base study, but received only Medisorb naltrexone 380 mg in this extension study, administered via IM injection once every 4 weeks.
From the date of successful completion of Study ALK21-006 (base study [NCT01218997])), all subjects, including those who received oral naltrexone during the base study, were given the option to enroll in this extension study.
Study investigators ensured that subjects were opioid-free and did not demonstrate evidence of withdrawal prior to administration of VIVITROL therapy. If the investigator suspected recent clinically significant opioid use, a naloxone challenge test was performed. The naloxone challenge was not performed in a subject presenting clinical signs or symptoms of opioid withdrawal or in a subject whose urine contained opioids.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00156936
|Study Director:||Bernard L. Silverman, MD||Alkermes, Inc.|