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A Study of HBS-201 (Pitolisant Delayed-release)

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Conditions

NarcolepsyPitolisant hydrochloridePitolisant delayed-release

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-05-21
Study Completion:2025-10-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT07051252

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Has hypersomnolence due to another medical disorder.
  2. 2. Is currently taking or has taken WAKIX (pitolisant).
  3. 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. 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.

Contacts and Locations

Study Locations (Sites)

Harmony Site 9
San Ramon, California, 94583
United States
Harmony Site 14
Brandon, Florida, 33511
United States
Harmony Site 4
Miami, Florida, 33176
United States
Harmony Site 8
Atlanta, Georgia, 30328
United States
Harmony Site 13
Newton, Massachusetts, 02459
United States
Harmony Site 11
Troy, Michigan, 48085
United States
Harmony Site 10
Denver, North Carolina, 28037
United States
Harmony Site 2
Huntersville, North Carolina, 28078
United States
Harmony Site 6
Canton, Ohio, 44718
United States
Harmony Site 1
Cincinnati, Ohio, 45245
United States
Harmony Site 15
Wyomissing, Pennsylvania, 19610
United States
Harmony Site 5
Columbia, South Carolina, 29201
United States
Harmony Site 12
North Charleston, South Carolina, 29406
United States
Harmony Site 3
Austin, Texas, 78731
United States
Harmony Site 7
Morgantown, West Virginia, 26506
United States

Collaborators and Investigators

Sponsor: Harmony Biosciences Management, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-21
Study Completion Date2025-10-13

Study Record Updates

Study Start Date2025-05-21
Study Completion Date2025-10-13

Terms related to this study

Keywords Provided by Researchers

  • Narcolepsy
  • Pitolisant hydrochloride
  • Pitolisant delayed-release

Additional Relevant MeSH Terms

  • Narcolepsy