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

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Study sites: 40 to 42v4
  2. Trial sites expanded: 22 → 40 locationsv3
  3. Primary endpoint(s) modifiedv2 Show 4 more changesShow less
    • Trial sites expanded: 12 → 22 locations
    • Eligibility criteria shortened, about 22 words
    • Secondary endpoints: 16 to 19
    • Study description shortened, about 38 words
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07500090
Lead Sponsor Harmony Biosciences Management, Inc.
Conditions
(from sponsor)		 Idiopathic Hypersomnia
Related terms Disorders of Excessive Somnolence, Fatigue, Idiopathic Hypersomnia
Enrollment 248 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov