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Clinical Trials in the USA / NCT07675135
Recruiting Phase 3

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

NCT07675135 · tracked via the Priya Life Science USA tracker
Sponsor
Harmony Biosciences Management, Inc.
Phase
Phase 3
Started
2026-06-04
Last updated
2026-08-27

Condition(s) studied

EDSCataplexyFatigueNarcolepsy

Investigational drug(s) / intervention(s)

HBS-301Placebo

HBS-301: HBS-301 tablet

Placebo: Placebo tablet

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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, 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 Criteria: * 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).

Primary outcome measure(s)

Trial sites (53)

FacilityCityRegionStatus
Sleep Disorders Center of Alabama Birmingham Alabama Not Yet Recruiting
Springhill Medical Center Mobile Alabama Not Yet Recruiting
Phoenix Medical Group, PC Peoria Arizona Recruiting
West Coast Pulmonary & Sleep Disorders Center Lancaster California Not Yet Recruiting
Santa Monica Clinical Trials Los Angeles California Recruiting
Stanford Center for Sleep Sciences and Medicine Redwood City California Recruiting
University of California San Francisco San Francisco California Not Yet Recruiting
Trial Site Solutions San Ramon California Recruiting
Alpine Clinical Research Center, Inc Boulder Colorado Recruiting
Delta Waves LLC Colorado Springs Colorado Recruiting
PharmaDev Clinical Research Institute, LLC Miami Florida Recruiting
Florida Pediatric Sleep Disorders Institute Winter Park Florida Recruiting
Neurotrials Research Inc Atlanta Georgia Recruiting
Sleep Practitioners, LLC Macon Georgia Recruiting
Southeast Lung Associates Research Rincon Georgia Recruiting
Clinical Research Institute Stockbridge Stockbridge Georgia Recruiting
NorthShore University HealthSystem Glenview Illinois Not Yet Recruiting
OSF St Francis Medical Center Peoria Illinois Not Yet Recruiting
Fort Wayne Neurological Center Fort Wayne Indiana Not Yet Recruiting
University of Kansas Hospital Main Campus Kansas City Kansas Not Yet Recruiting
Henry Ford Medical Center Novi Michigan Not Yet Recruiting
Revive Research Institute, Inc Southfield Michigan Recruiting
Clinical Neurophysiology Services Sterling Heights Michigan Recruiting
St. Lukes Sleep Medicine and Research Center Chesterfield Missouri Recruiting
Patient First MD Middletown New Jersey Not Yet Recruiting
Northwell Health Physician Partners New Hyde Park New York Not Yet Recruiting
Research Carolina Elite LLC Denver North Carolina Not Yet Recruiting
Clinical Research of Gastonia Gastonia North Carolina Recruiting
Stern Research Partners Huntersville North Carolina Recruiting
Intrepid Research, LLC Cincinnati Ohio Recruiting
The Cleveland Clinic Foundation Cleveland Ohio Not Yet Recruiting
Neurology Care Ardmore Oklahoma Not Yet Recruiting
Abington Neurological Associates Abington Pennsylvania Recruiting
Geisinger Medical Center Danville Pennsylvania Not Yet Recruiting
University of Pittsburgh Pittsburgh Pennsylvania Not Yet Recruiting
Berks Schuylkill Respiratory Specialists Wyomissing Pennsylvania Recruiting
Infinity Medical Research Inc East Providence Rhode Island Not Yet Recruiting
Lowcountry Lung and Critical Care PA Charleston South Carolina Recruiting
Medical University of South Carolina Charleston South Carolina Not Yet Recruiting
Bogan Sleep Consultants, LLC Columbia South Carolina Recruiting

+ 13 more sites — see the full list on the official registry below.

More Harmony Biosciences Management, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07675135 on ClinicalTrials.gov ↗ ← All trials in the USA