Status: Recruiting
A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy
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.
Participants needed: 258
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Harmony Biosciences Management, Inc.Updated: Jun 30, 2026Locations: 14
Eligibility criteria
Has a current documented diagnosis of NT1 or NT2 per the International Classific... [+2]
Has hypersomnia due to another medical disorder. [+6]