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
NCT ID: NCT03433131
Last Updated: 2019-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Brief Summary
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Detailed Description
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Conditions
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Interventions
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Pitolisant
Tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Harmony Biosciences Management, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Thorpy, MD
Role: PRINCIPAL_INVESTIGATOR
Albert Einstein College of Medicine
Locations
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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
Norwalk Hospital Sleep Disorders Center
Norwalk, Connecticut, United States
Clinical Neurosciences fo Tampa Bay
Clearwater, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Sleep Medicine Specialists of South Florida, PA
Miami, Florida, United States
Child Lung, Asthma Sleep Specialists
Winter Park, Florida, United States
Emory University
Atlanta, Georgia, United States
NeuroTrials Research Center
Atlanta, Georgia, United States
The Neurological Center of North Georgia
Gainesville, Georgia, United States
Critical Healthcare Decisions
Savannah, Georgia, United States
Northwestern Medical Group
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
NorthShore Uni HealthSys-Glenbrook Hospital
Glenview, Illinois, United States
Northshore Sleep Medicine
Northbrook, Illinois, United States
Indiana Internal Medicine Consultants
Greenwood, Indiana, United States
The University of Kansas Health System
Fairway, Kansas, United States
Norton Pulmonary Specialists
Louisville, Kentucky, United States
Maine Medical Partners - Neurology
Scarborough, Maine, United States
The Center for Sleep and Wake Disorders
Chevy Chase, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
The University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health System
Novi, Michigan, United States
Bronson Sleep Health
Portage, Michigan, United States
Alliance Health Shelby Family Medicine
Shelby, Michigan, United States
Fairview Health Services
Brooklyn Park, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
St. Lukes Hospital, Sleep Medicine
Chesterfield, Missouri, United States
University of Missouri
Columbia, Missouri, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Norwell Health
New Hyde Park, New York, United States
NYU-FGP Comphrenhensive Epilepsy Center-Sleep Center
New York, New York, United States
Columbia University
New York, New York, United States
Unity Sleep Disorders Center
Rochester, New York, United States
University of Rochester Sleep Center
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Excel Psychiatric Associates, PA
Huntersville, North Carolina, United States
Raleigh Neurology Assoc., PA
Raleigh, North Carolina, United States
Neurology & Neuroscience Associates, Inc.
Akron, Ohio, United States
Intrepid Research, LLC
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio Sleep Medicine Institute
Dublin, Ohio, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Legacy Medical Group Sleep Medicine
Portland, Oregon, United States
Collegeville Family Practice
Berwyn, Pennsylvania, United States
Paoli Sleep Center
Paoli, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Maria J. Sunseri, MD, LLC
Pittsburgh, Pennsylvania, United States
Abington Neurological Associates
Willow Grove, Pennsylvania, United States
Respitory Specialists
Wyomissing, Pennsylvania, United States
Brown Medicine/Rhode Island Hospital
West Warwick, Rhode Island, United States
Bogan Sleep Consultants
Columbia, South Carolina, United States
Sleep Medicine Associates of Texas
Dallas, Texas, United States
Houston Neurology & Sleep Center
Houston, Texas, United States
Sleep Therapy & Research Center
San Antonio, Texas, United States
Comprehensive Sleep Medicine Associates
Sugar Land, Texas, United States
Chalottesville Neurology and Sleep Medicine
Charlottesville, Virginia, United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Stultz Sleep and Behavioral Health
Barboursville, West Virginia, United States
Medical College of Wisonsin
Milwaukee, Wisconsin, United States
Countries
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Related Links
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Program website to provide information to both prosective patients and physicians
Other Identifiers
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HBS-101-CL-001
Identifier Type: -
Identifier Source: org_study_id
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