NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

RecruitingPhase 3

Sponsor: Harmony Biosciences Management, Inc.

Conditions: Idiopathic Hypersomnia

Interventions: HBS-301 tablet, Placebo

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

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.
* 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).

Locations (40)

Birmingham, Alabama, United States
Peoria, Arizona, United States
Redwood City, California, United States
San Ramon, California, United States
Santa Monica, California, United States
Boulder, Colorado, United States
Colorado Springs, Colorado, United States
Miami, Florida, United States
Winter Park, Florida, United States
Atlanta, Georgia, United States
Macon, Georgia, United States
Rincon, Georgia, United States
Stockbridge, Georgia, United States
Fort Wayne, Indiana, United States
Southfield, Michigan, United States
Sterling Heights, Michigan, United States
Chesterfield, Missouri, United States
Gastonia, North Carolina, United States
Huntersville, North Carolina, United States
Morrisville, North Carolina, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Ardmore, Oklahoma, United States
Abington, Pennsylvania, United States
West Chester, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
East Providence, Rhode Island, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Nashville, Tennessee, United States
+ 10 more on CT.gov