Clinical Trial

A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)

Recruiting Phase 3
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Summary
This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in adult participants (ages ≥18 years) with idiopathic hypersomnia (IH).
Protocol Amendment History 3 changes
notable Trial sites expanded: 22 -> 40 locations 2026-08-14
critical Primary endpoint(s) modified 2026-07-03
notable Trial sites expanded: 12 -> 22 locations 2026-07-03
Trial Details
NCT Number NCT07500090
Lead Sponsor Harmony Biosciences Management, Inc.
Conditions Idiopathic Hypersomnia
Enrollment 248 participants
Start Date 2026-03-16
Primary Completion 2027-10 (estimated)
Study Completion 2028-10 (estimated)
Updated on ClinicalTrials.gov 2026-08-13