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Expanded Access Program to Provide Treatment With Pitolisant to Adult Patients in the U.S. With Excessive Daytime Sleepiness Associated With Narcolepsy With or Without Cataplexy | Clinical Trials | Clareo Health

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Expanded Access Program to Provide Treatment With Pitolisant to Adult Patients in the U.S. With Excessive Daytime Sleepiness Associated With Narcolepsy With or Without Cataplexy

An Open Label Expanded Access Program Intended to Provide Treatment With HBS-101 (Pitolisant) to Adult Patients in the U.S. With Excessive Daytime Sleepiness Associated With Narcolepsy With or Without Cataplexy

NCT03433131•Harmony Biosciences Management, Inc.

View on ClinicalTrials.gov

Summary

This EAP will be open to provide access to treatment with pitolisant while a U.S. New Drug Application (NDA) is being prepared and submitted for review for marketing approval. This program will be open to adult patients in the U.S. with Excessive Daytime Sleepiness (EDS) associated with narcolepsy, with or without cataplexy. Pitolisant will be made available through treating physicians participating in the program.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. In the opinion of the treating physician, the patient is capable of understanding and complying with protocol and program requirements, oral drug administration and care instructions.
•2. The patient or, when applicable, the patient's legally acceptable representative, signs and dates a written, ICF and any required privacy authorization prior to the initiation of any program procedures.
•3. Men or women, 18 years of age and over.
•4. Patients with a diagnosis of narcolepsy with or without cataplexy according to the ICSD or DSM criteria at the time of diagnosis.
•5. Patients should be free of prohibited treatments or have discontinued them for at least 7 days prior to the start of treatments.
•6. Women of child-bearing potential must have a negative serum pregnancy test performed at the screening visit.
•7. Due to the effectiveness of hormonal contraceptives potentially being reduced when used with pitolisant, alternative or concomitant barrier methods of contraception are required for patients taking hormonal contraceptives (e.g., ethinyl estradiol) when taking pitolisant and for at least 21 days after discontinuation of pitolisant treatment.

Exclusion Criteria

•1. The patient has severe hepatic impairment (Child-Pugh C).
•2. The patient is a woman who is breastfeeding or plans to breastfeed during their participation.
•3. The patient has, in the judgment of the treating physician, a history or current medical condition that could affect safety or poses an additional risk to the patient by their participation in the program.
•4. The patient is at high risk for suicide defined as a suicide attempt within the past year, significant risk determined by the investigator interview, or use of the Columbia Suicide Severity Rating Scale (C-SSRS).
•5. The patient has a history of hypersensitivity or allergic reaction to pitolisant or any inactive ingredient of the formulation.
•6. Current or recent (within one year) history of a substance abuse or dependence disorder including alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM-V).
•7. Patients with a known history of long QTc syndrome (e.g. syncope or arrhythmia) or any significant history of a serious abnormality of the ECG (e.g. recent myocardial infarction), or QTc Fridericia higher than 450 ms for male and 470 ms for female (electrocardiogram Fridericia's corrected QT interval = QT / 3√ RR).
•8. Significant abnormality in the physical examination or clinical laboratory results.
•9. Prior severe adverse reactions to CNS stimulants.

Locations (71)

Sleep Disorders Center of Alabama

Birmingham, Alabama, United States

CPC

Cullman, Alabama, United States

Xenoscience

Phoenix, Arizona, United States

Xenoscience

Phoenix, Arizona, United States

Foothills Neurology

Phoenix, Arizona, United States

Mayo Clinic

Scottsdale, Arizona, United States

Sleep Medicine Specialists of California

San Ramon, California, United States

Santa Monica Sleep Disorders Center

Santa Monica, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Colorado Sleep Institute

Boulder, Colorado, United States

Key Dates

Last Updated

August 28, 2019

Conditions

Narcolepsy Without CataplexyNarcolepsy With Cataplexy

Interventions

Pitolisant

DRUG

A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy

NCT07363720

Narcolepsy Type 1 (NT1)Narcolepsy With Cataplexy

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COMPLETEDPHASE2

Clarithromycin Mechanisms in Hypersomnia Syndromes

NCT04026958

Narcolepsy Without CataplexyIdiopathic Hypersomnia+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Expanded Access Program to Provide Treatment With Pitolisant to Adult Patients in the U.S. With Excessive Daytime Sleepiness Associated With Narcolepsy With or Without Cataplexy

Inclusion Criteria

Exclusion Criteria

A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy

Clarithromycin Mechanisms in Hypersomnia Syndromes

Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes

Xyrem and Brain Dopamine in Narcolepsy

A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy

Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP)