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A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 50 → 53 locationsv3
  2. Trial sites expanded: 14 → 50 locationsv2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 treating excessive daytime sleepiness (EDS), cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.
Trial Details
NCT Number NCT07675135
Lead Sponsor Harmony Biosciences Management, Inc.
Conditions
(from sponsor)		 EDS, Cataplexy, Fatigue, Narcolepsy
Related terms Cataplexy, Fatigue, Narcolepsy
Enrollment 258 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov