RecruitingPhase 3NCT07500090

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

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH) Followed by an Open-label Extension

Sponsor

Harmony Biosciences Management, Inc.

Enrollment

248 participants

Start Date

Mar 16, 2026

Study Type

INTERVENTIONAL

Conditions

Idiopathic Hypersomnia

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called HBS-301 tablet and a drug called Placebo for people with idiopathic hypersomnia. The study is currently recruiting participants at 40 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHBS-301 tablet

HBS-301 tablet

DRUGPlacebo

Placebo tablet

Locations(42)

Sleep Disorders Center of Alabama

Birmingham, Alabama, United States

Phoenix Medical Group LLC

Peoria, Arizona, United States

Stanford Center for Sleep Medicine

Redwood City, California, United States

Trial Site Solutions

San Ramon, California, United States

Santa Monica Clinical Trials

Santa Monica, California, United States

Alpine Clinical Research Center, Inc.

Boulder, Colorado, United States

Delta Waves LLC

Colorado Springs, Colorado, United States

PharmDev Research Institute, LLC

Miami, Florida, United States

Central Florida Pediatric Sleep Disorders Institute (Florida Pediatric Research Institute, LLC)

Winter Park, Florida, United States

NeuroTrials Research Inc.

Atlanta, Georgia, United States

Sleep Practitioners, LLC

Macon, Georgia, United States

Southeast Lung Associates Research

Rincon, Georgia, United States

Clinical Research Institute Stockbridge

Stockbridge, Georgia, United States

Fort Wayne Neurological Center

Fort Wayne, Indiana, United States

Revive Research Institute

Southfield, Michigan, United States

Clinical Neuropsychology Services

Sterling Heights, Michigan, United States

St. Luke's Hospital, Sleep Medicine and Research Center

Chesterfield, Missouri, United States

Clinical Research of Gastonia

Gastonia, North Carolina, United States

Stern Research Partners, LLC

Huntersville, North Carolina, United States

David Kudrow, MD

Morrisville, North Carolina, United States

Neuroscience Research Center, LLC

Canton, Ohio, United States

Intrepid Research

Cincinnati, Ohio, United States

Neurology Care

Ardmore, Oklahoma, United States

Abington Neurological Associates

Abington, Pennsylvania, United States

Suburban Research Associates

West Chester, Pennsylvania, United States

Berks Schuylkill Respiratory Specialists

Wyomissing, Pennsylvania, United States

Infinity Medical Research Inc.

East Providence, Rhode Island, United States

Lowcountry Lung and Critical Care, PA

Charleston, South Carolina, United States

Bogan Sleep Consultants, LLC

Columbia, South Carolina, United States

K2 Medical Research

Nashville, Tennessee, United States

Aayus Research

Austin, Texas, United States

Southwest Family Medicine Associates

Dallas, Texas, United States

Metroplex Pulmonary and Sleep Center

McKinney, Texas, United States

Sleep Therapy and Research Center

San Antonio, Texas, United States

HAS Research

San Antonio, Texas, United States

Tricoastal Narcolepsy and Sleep Disorders Center

Sugar Land, Texas, United States

TPMG Clinical Research

Williamsburg, Virginia, United States

Washington State University Sleep and Performance Center

Spokane, Washington, United States

West Virginia University

Morgantown, West Virginia, United States

University of Washington

Madison, Wisconsin, United States

AMNDX Inc

Markham, Ontario, Canada

Jodha Tishon Inc

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT07500090

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