Clinical Trial

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

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 treating excessive daytime sleepiness (EDS), cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.
Protocol Amendment History 1 change
notable Trial sites expanded: 14 -> 50 locations 2026-08-13
Trial Details
NCT Number NCT07675135
Lead Sponsor Harmony Biosciences Management, Inc.
Conditions EDS, Cataplexy, Fatigue, Narcolepsy
Enrollment 258 participants
Start Date 2026-06-04
Primary Completion 2027-10 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-08-12