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

Recruiting Phase 3 Interventional Study
EDS Cataplexy Fatigue Narcolepsy
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
258 (estimated)
Sponsor
Harmony Biosciences Management, Inc. · Industry
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About This Trial

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 Locations
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Eligibility Criteria
Inclusion Criteria: * Has a current documented diagnosis of NT1 or NT2 per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or the ICSD-3 Text Revision (ICSD-3-TR) within the last 10 years. * Has EDS. * If taking a permitted chronic concomitant medication or supplement, i…
Contacts

Michelle Manuel

847-903-4610

clinicaltrials@harmonybiosciences.com

CONTACT

Katie Wilmsen

443-309-5556

clinicaltrials@harmonybiosciences.com

CONTACT