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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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).

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Double-Blind Treatment Period HBS-301 		HBS-301 tablets administered once daily in the morning upon wakening
  • Drug: HBS-301
    HBS-301 tablet
    Other names:
    • pitolisant delayed-release
Placebo Comparator
Double-blind Treatment Period Placebo 		Matching placebo tablets administered once daily in the morning upon wakening
  • Other: Placebo
    Placebo tablet
Experimental
Open-Label Extension Period HBS-301 		HBS-301 tablets administered once daily in the morning upon wakening
  • Drug: HBS-301
    HBS-301 tablet
    Other names:
    • pitolisant delayed-release

Recruiting Locations

Phoenix Medical Group, PC
Peoria, Arizona 85381

Santa Monica Clinical Trials
Los Angeles, California 90025

Alpine Clinical Research Center, Inc
Boulder, Colorado 80301

PharmaDev Clinical Research Institute, LLC
Miami, Florida 33176

Central Florida Pediatric Sleep Disorders Institute
Winter Park, Florida 32789

Neurotrials Research Inc
Atlanta, Georgia 30328
Contact:
Dennis Lacey
404-851-9934

Sleep Practitioners, LLC
Macon, Georgia 31210

Intrepid Research, LLC
Cincinnati, Ohio 45245

Respiratory Specialists
Wyomissing, Pennsylvania 19610

Lowcountry Lung and Critical Care PA
Charleston, South Carolina 29406

Bogan Sleep Consultants, LLC
Columbia, South Carolina 29201

Southwest Family Medicine
Dallas, Texas 75235

Sleep Therapy & Research Center
San Antonio, Texas 78229

Sleep and Performance Research Center
Spokane, Washington 99202

More Details

Status
Recruiting
Sponsor
Harmony Biosciences Management, Inc.

Study Contact

Michelle Manuel
847-903-4610
clinicaltrials@harmonybiosciences.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.