214
Participants
Start Date
May 25, 2022
Primary Completion Date
September 8, 2023
Study Completion Date
September 8, 2023
Open-label pitolisant
"Pitolisant 4.45 mg tablets: white, round, plain, biconvex film-coated tablet, 3.7 mm in diameter. Each tablet contains 5 mg of pitolisant hydrochloride equivalent to 4.45 mg of pitolisant.~Pitolisant 17.8 mg tablets: white, round, plain, biconvex film-coated tablet, 7.5 mm in diameter. Each tablet contains 20 mg of pitolisant hydrochloride equivalent to 17.8 mg of pitolisant."
Double-blind placebo
Matching placebo tablets will be provided for each strength of active pitolisant film-coated tablets.
Double-blind pitolisant
"Pitolisant 4.45 mg tablets: white, round, plain, biconvex film-coated tablet, 3.7 mm in diameter. Each tablet contains 5 mg of pitolisant hydrochloride equivalent to 4.45 mg of pitolisant.~Pitolisant 17.8 mg tablets: white, round, plain, biconvex film-coated tablet, 7.5 mm in diameter. Each tablet contains 20 mg of pitolisant hydrochloride equivalent to 17.8 mg of pitolisant."
Northwell Health, New Hyde Park
Abington Neurological Associates, Willow Grove
Brian Abaluck, LLC, Paoli
Respiratory Specialists, Wyomissing
Helene A. Emsellem MD PC, Chevy Chase
Children's Hospital of the King's Daughter, Norfolk
West Virginia University - Department of Neurology, Morgantown
Duke University School of Medicine, Durham
Research Carolina Elite LLC, Denver
Clinical Research of Gastonia, Gastonia
ARSM Research, Huntersville
Bogan Sleep Consultants, Columbia
Lowcountry Lung Critical Care, North Charleston
Medical University of South Carolina- Institute of Psychiatry, Charleston
Neurotrials Research Inc., Atlanta
The Neurological Center of North GA, Gainesville
Florida Pediatric Research Institute, Winter Park
Sleep Medicine Specialists of South Florida, PA, Miami
Meris Clinical Research, Brandon
Pasadena Center For Medical Research, LLC, St. Petersburg
St. Francis Medical Institute, Clearwater
Advanced Center for Sleep Disorders, Chattanooga
Neurology Clinic, P.C., Cordova
Ohio Sleep Medicine and Neuroscience Institue, Dublin
Rainbow Babies Children's Hospital, Cleveland
North Star Medical Research, Middleburg
Cleveland Clinc, Cleveland
NeuroScience Research Center, LLC, Canton
Intrepid Research, LLC, Cincinnati
Clinical Neurophysiology Services, Sterling Heights
Henry Ford Health System, Novi
Bronson Sleep Health, Portage
University of Wisconsin-Madison, Madison
Minnesota Lung Center, Edina
Minnesota Lung Center, Woodbury
NorthShore Uni HealthSys-Glenbrook Hospital, Glenview
Northwestern University, Chicago
OSF HealthCare Saint Francis Medical Center, Peoria
St. Luke's Sleep Medicine and Research Center, Chesterfield
Clayton Sleep Institute, St Louis
Great Plains Health, North Platte
CardioVoyage, Ardmore
Northwest Houston Neurology and Sleep, Tomball
Comprehensive Sleep Medicine Associates, Sugar Land
Central Texas Neurology Consultants, PA, Round Rock
FutureSearch Trials of Neurology LP, Austin
Alpine Clinical Research Center, Boulder
Mayo Clinic, Scottsdale
Phoenix Medical Group, Peoria
Cedars-Sinai Medical Towers, Los Angeles
University of California- Los Angeles, Los Angeles
Santa Monica Clinical Trials, Santa Monica
SDS Clinical Trials Inc., Santa Ana
Sleep Medicine Specialists of California, San Ramon
Norwalk Hospital Sleep Center, Norwalk
Boston Children's Hospital, Boston
Neurocare, INC, Newton
Neurology Specialists of Monmouth County, PA, West Long Branch
Harmony Biosciences Management, Inc.
INDUSTRY