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NCT07675135PHASE3Recruiting

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

Harmony Biosciences Management, Inc.

Start Date

6/4/2026

Completion Date

11/1/2027

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.

Detailed Description

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 EDS, cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy. Approximately 258 participants are planned for randomization into the study. The study will consist of a Screening/Baseline Period (up to 28 days), a Double-blind Treatment Period (8 weeks), an optional Open-label Extension Period (1 year), and 30 days of safety follow-up.

Eligibility Criteria

Age Range: 18 years to No maximum

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).

Interventions

DRUG

HBS-301

OTHER

Placebo

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Conditions

EDSCataplexyFatigueNarcolepsy

Locations

Phoenix Medical Group, PC

Peoria, Arizona 85381

United States

Santa Monica Clinical Trials

Los Angeles, California 90025

United States

Alpine Clinical Research Center, Inc

Boulder, Colorado 80301

United States

PharmaDev Clinical Research Institute, LLC

Miami, Florida 33176

United States

Central Florida Pediatric Sleep Disorders Institute

Winter Park, Florida 32789

United States

Neurotrials Research Inc

Atlanta, Georgia 30328

United States

Sleep Practitioners, LLC

Macon, Georgia 31210

United States

Intrepid Research, LLC

Cincinnati, Ohio 45245

United States

Respiratory Specialists

Wyomissing, Pennsylvania 19610

United States

Lowcountry Lung and Critical Care PA

Charleston, South Carolina 29406

United States

Bogan Sleep Consultants, LLC

Columbia, South Carolina 29201

United States

Southwest Family Medicine

Dallas, Texas 75235

United States

Sleep Therapy & Research Center

San Antonio, Texas 78229

United States

Sleep and Performance Research Center

Spokane, Washington 99202

United States