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

Launched by ALKERMES, INC. · Oct 8, 2010

Keywords

ClinConnect Summary

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 rec...

Gender

ALL

Eligibility 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