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Alkermes Has Initiated Vibrance-3 Phase 2 Study Evaluating The Safety And Efficacy Of ALKS 2680 Compared To Placebo In Adults With Idiopathic Hypersomnia

Benzinga·04/01/2025 11:08:51
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  • Vibrance-3 is a phase 2, randomized, double-blind, dose-range-finding, placebo-controlled study evaluating the safety and efficacy of ALKS 2680 in adults with IH. Participants will be randomized to receive one of three doses of ALKS 2680 (10 mg, 14 mg or 18 mg) or placebo to be taken once-daily for eight weeks. 
  • The primary endpoint will assess, by dose level, whether participants taking ALKS 2680 experience a greater decrease in sleepiness compared to participants taking placebo alone, as measured by the change in Epworth Sleepiness Scale (ESS) score. 
  • Secondary endpoints include change in Idiopathic Hypersomnia Severity Scale (IHSS) score and incidence of adverse events. The study is expected to enroll approximately 96 patients with IH across sites in the U.S., Australia and Europe. 
  • Participants who complete the study will be eligible to continue in a long-term, open-label, safety study (NCT06767683).