A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Idiopathic Hypersomnia

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 adult participants (ages ≥18 years) with idiopathic hypersomnia (IH).

Key facts

Study ID

NCT07500090

Run by

Harmony Biosciences Management, Inc.

People needed

248

Starts

2026-03-16

Expected to finish

2028-10-01

Last updated by the study team

2026-07-02

Who can join

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

You may qualify if…

• Has a current documented diagnosis of IH per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or Text Revision (ICSD-3-TR) criteria with confirmatory polysomnogram (PSG) with multiple sleep latency test (MSLT; and if applicable, a 24-hour PSG report or an actigraphy report with sleep log) on file that led to the diagnosis and was completed within the last 10 years.
• Has EDS.
• Has moderate to very severe symptoms of IH.
• 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 use of any treatment that could affect daytime sleepiness (including but not limited to stimulants, modafinil, and armodafinil) used on an as-needed basis 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.
• Has a history of moderate or severe hepatic impairment.
• Has a body surface area (BSA)-corrected estimated glomerular filtration rate (eGFR) <60 mL/min.
• Has a known history of long QT syndrome or any significant history of a serious abnormality of the electrocardiogram (ECG).

Where it is running

• Sleep Disorders Center of Alabama — Birmingham, Alabama, United States (enrolling)
• Stanford Center for Sleep Medicine — Redwood City, California, United States (enrolling)
• Santa Monica Clinical Trials — Santa Monica, California, United States (enrolling)
• Alpine Clinical Research Center, Inc. — Boulder, Colorado, United States (enrolling)
• PharmDev Research Institute, LLC — Miami, Florida, United States (enrolling)
• Central Florida Pediatric Sleep Disorders Institute (Florida Pediatric Research Institute, LLC) — Winter Park, Florida, United States (enrolling)
• NeuroTrials Research Inc. — Atlanta, Georgia, United States (enrolling)
• Sleep Practitioners, LLC — Macon, Georgia, United States (enrolling)
• Phillip Nowlin — Stockbridge, Georgia, United States (enrolling)
• Revive Research Institute — Southfield, Michigan, United States (enrolling)
• St. Luke's Hospital, Sleep Medicine and Research Center — Chesterfield, Missouri, United States (enrolling)
• Clinical Research of Gastonia — Gastonia, North Carolina, United States (enrolling)
• Stern Research Partners, LLC — Huntersville, North Carolina, United States (enrolling)
• David Kudrow, MD — Morrisville, North Carolina, United States (enrolling)
• Suburban Research Associates — West Chester, Pennsylvania, 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)
• K2 Medical Research — Nashville, Tennessee, United States (enrolling)
• Southwest Family Medicine Associates — Dallas, Texas, United States (enrolling)
• HAS Research — San Antonio, Texas, United States (enrolling)
• West Virginia University — Morgantown, West Virginia, 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.