RECRUITING

An Open-Label Study of HBS-201 (Pitolisant Delayed-release)

Description

The purpose of this study is to assess the tolerability of HBS-201 when starting at a therapeutic dose in adult participants with narcolepsy.

Conditions

Study Overview

Study Details

Study overview

The purpose of this study is to assess the tolerability of HBS-201 when starting at a therapeutic dose in adult participants with narcolepsy.

A Phase 1b, Open-Label Study of HBS-201 (Pitolisant Delayed-release) in Adult Participants With Narcolepsy

An Open-Label Study of HBS-201 (Pitolisant Delayed-release)

Condition
Narcolepsy
Intervention / Treatment

-

Contacts and Locations

San Ramon

Harmony Site 9, San Ramon, California, United States, 94583

Brandon

Harmony Site 14, Brandon, Florida, United States, 33511

Miami

Harmony Site 4, Miami, Florida, United States, 33176

Atlanta

Harmony Site 8, Atlanta, Georgia, United States, 30328

Newton

Harmony Site 13, Newton, Massachusetts, United States, 02459

Troy

Harmony Site 11, Troy, Michigan, United States, 48085

Denver

Harmony Site 10, Denver, North Carolina, United States, 28037

Huntersville

Harmony Site 2, Huntersville, North Carolina, United States, 28078

Canton

Harmony Site 6, Canton, Ohio, United States, 44718

Cincinnati

Harmony Site 1, Cincinnati, Ohio, United States, 45245

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Has a current documented diagnosis of narcolepsy type 1 or narcolepsy type 2 per International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria.
  • 1. Has hypersomnolence due to another medical disorder.
  • 2. Is currently taking or has taken WAKIX (pitolisant).
  • 3. Has participated in an interventional research study involving another investigational medication, device, or behavioral treatment within 30 days or within 5 half-lives of the investigational medication prior to Screening.
  • 4. Based on the judgment of the Investigator, is unsuitable for the study for any reason, including but not limited to unstable or uncontrolled medical conditions (including psychiatric and neurological conditions) or a medical condition that might interfere with the conduct of the study, confound interpretation of study results, pose a health risk to the participant, or compromise the integrity of the study.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Harmony Biosciences Management, Inc.,

Study Record Dates

2025-11