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

RecruitingPhase 3

Sponsor: Harmony Biosciences Management, Inc.

Conditions: EDS, Cataplexy, Fatigue, Narcolepsy

Interventions: HBS-301, 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 treating excessive daytime sleepiness (EDS), cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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).

Locations (50)

Birmingham, Alabama, United States
Mobile, Alabama, United States
Peoria, Arizona, United States
Lancaster, California, United States
Los Angeles, California, United States
Redwood City, California, United States
San Francisco, California, United States
San Ramon, 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
Glenview, Illinois, United States
Peoria, Illinois, United States
Fort Wayne, Indiana, United States
Kansas City, Kansas, United States
Novi, Michigan, United States
Southfield, Michigan, United States
Sterling Heights, Michigan, United States
Chesterfield, Missouri, United States
Middletown, New Jersey, United States
New Hyde Park, New York, United States
Denver, North Carolina, United States
Gastonia, North Carolina, United States
Huntersville, North Carolina, United States
Cincinnati, Ohio, United States
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