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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: EDS, Cataplexy, Fatigue, Narcolepsy

In brief

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.

Key facts

Study ID

NCT07675135

Run by

Harmony Biosciences Management, Inc.

People needed

258

Starts

2026-06-04

Expected to finish

2027-11-01

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Phoenix Medical Group, PC — Peoria, Arizona, United States (enrolling)
• Santa Monica Clinical Trials — Los Angeles, California, United States (enrolling)
• Alpine Clinical Research Center, Inc — Boulder, Colorado, United States (enrolling)
• PharmaDev Clinical Research Institute, LLC — Miami, Florida, United States (enrolling)
• Central Florida Pediatric Sleep Disorders Institute — Winter Park, Florida, United States (enrolling)
• Neurotrials Research Inc — Atlanta, Georgia, United States (enrolling)
• Sleep Practitioners, LLC — Macon, Georgia, United States (enrolling)
• Intrepid Research, LLC — Cincinnati, Ohio, United States (enrolling)
• Respiratory Specialists — Wyomissing, Pennsylvania, United States (enrolling)
• Lowcountry Lung and Critical Care PA — Charleston, South Carolina, United States (enrolling)
• Bogan Sleep Consultants, LLC — Columbia, South Carolina, United States (enrolling)
• Southwest Family Medicine — Dallas, Texas, United States (enrolling)
• Sleep Therapy & Research Center — San Antonio, Texas, United States (enrolling)
• Sleep and Performance Research Center — Spokane, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.