Status and phase
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About
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®).
Full description
Enrolled subjects continued to receive the same dose strength of Medisorb naltrexone (ie, 190 mg or 380 mg) they had received in Study ALK21-003-EXT (NCT01218971). Assigned dose strength (high or low) was not revealed to the subject, the study investigators, or any blinded member of the clinical study team for the duration of the study period. Placebo was not administered.
Enrollment
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Inclusion and exclusion criteria
Primary Inclusion Criteria:
Primary Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
108 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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