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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT07500090

Public ClinicalTrials.gov record NCT07500090. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 7, 2026, 1:34 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT07500090
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Enrollment
248 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 15, 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2028
Last update posted
Aug 12, 2026

2026 – 2028

United States locations

U.S. sites
40
U.S. states
21
U.S. cities
39
Facility City State ZIP Site status
Sleep Disorders Center of Alabama Birmingham Alabama 35213 Recruiting
Phoenix Medical Group LLC Peoria Arizona 85381 Recruiting
Stanford Center for Sleep Medicine Redwood City California 94063 Recruiting
Trial Site Solutions San Ramon California 04583 Recruiting
Santa Monica Clinical Trials Santa Monica California 90404 Recruiting
Alpine Clinical Research Center, Inc. Boulder Colorado 80301 Recruiting
Delta Waves LLC Colorado Springs Colorado 80918 Recruiting
PharmDev Research Institute, LLC Miami Florida 33176 Recruiting
Central Florida Pediatric Sleep Disorders Institute (Florida Pediatric Research Institute, LLC) Winter Park Florida 32789 Recruiting
NeuroTrials Research Inc. Atlanta Georgia 30328 Recruiting
Sleep Practitioners, LLC Macon Georgia 31210 Recruiting
Southeast Lung Associates Research Rincon Georgia 31326 Recruiting
Clinical Research Institute Stockbridge Stockbridge Georgia 30281 Recruiting
Fort Wayne Neurological Center Fort Wayne Indiana 46804 Recruiting
Revive Research Institute Southfield Michigan 48975 Recruiting
Clinical Neuropsychology Services Sterling Heights Michigan 48314 Recruiting
St. Luke's Hospital, Sleep Medicine and Research Center Chesterfield Missouri 63017 Recruiting
Clinical Research of Gastonia Gastonia North Carolina 28054 Recruiting
Stern Research Partners, LLC Huntersville North Carolina 28078 Recruiting
David Kudrow, MD Morrisville North Carolina 27560 Recruiting
Neuroscience Research Center, LLC Canton Ohio 44718 Recruiting
Intrepid Research Cincinnati Ohio 45245 Recruiting
Neurology Care Ardmore Oklahoma 73401 Recruiting
Abington Neurological Associates Abington Pennsylvania 19001 Recruiting
Suburban Research Associates West Chester Pennsylvania 19380 Recruiting
Berks Schuylkill Respiratory Specialists Wyomissing Pennsylvania 19610 Recruiting
Infinity Medical Research Inc. East Providence Rhode Island 02914 Recruiting
Lowcountry Lung and Critical Care, PA Charleston South Carolina 29406 Recruiting
Bogan Sleep Consultants, LLC Columbia South Carolina 29201 Recruiting
K2 Medical Research Nashville Tennessee 37204 Recruiting
Aayus Research Austin Texas 78731 Recruiting
Southwest Family Medicine Associates Dallas Texas 75235 Recruiting
Metroplex Pulmonary and Sleep Center McKinney Texas 75069 Recruiting
Sleep Therapy and Research Center San Antonio Texas 30328 Recruiting
HAS Research San Antonio Texas 78240 Recruiting
Tricoastal Narcolepsy and Sleep Disorders Center Sugar Land Texas 77478 Recruiting
TPMG Clinical Research Williamsburg Virginia 23188 Recruiting
Washington State University Sleep and Performance Center Spokane Washington 99210 Recruiting
West Virginia University Morgantown West Virginia 26506 Recruiting
University of Washington Madison Wisconsin 53792 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07500090, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 12, 2026 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07500090 live on ClinicalTrials.gov.

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