A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy Followed by an Open-label Extension
Harmony Biosciences Management, Inc.
258 participants
Jun 4, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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, including nonprohibited antidepressants or wake-promoting agents, must be on a stable dose for at least 3 months prior to Screening and agree to continue at that stable dose for the Double-blind Treatment Period of the study. As needed (PRN) use of any treatment that could affect daytime sleepiness (including but not limited to oxybates, stimulants, modafinil, and armodafinil) is not permitted.
Exclusion Criteria7
- Has hypersomnia due to another medical disorder.
- Has a history of pitolisant use within 5 half-lives prior to Screening.
- Has a primary diagnosis of psychiatric illness, including depression, that is not well controlled (i.e., symptoms and medications have not been stable for at least 3 months prior to Screening).
- Has any history of bipolar disorder or psychosis
- Has acute or chronic liver disease or a history of moderate or severe hepatic impairment.
- Has a body surface area-corrected estimated glomerular filtration rate (eGFR) <60 mL/min.
- Has a known history of long QT syndrome or serious abnormality of the electrocardiogram (ECG).
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Interventions
HBS-301 tablet
Placebo tablet
Locations(14)
View Full Details on ClinicalTrials.gov
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NCT07675135