A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

128

Participants

Timeline

Start Date

August 19, 2022

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2025

Conditions
Idiopathic HypersomniaExcessive Daytime Sleepiness
Interventions
DRUG

Pitolisant

"Pitolisant 4.45 mg tablets~Pitolisant 17.8 mg tablets"

Trial Locations (32)

11042

Northwell Health, New Hyde Park

19090

Abington Neurological Associates, Willow Grove

19610

Respiratory Specialists, Wyomissing

27705

Duke University School of Medicine, Durham

28054

Clinical Research of Gastonia, Gastonia

28078

ARSM Research, Huntersville

29201

Bogan Sleep Consultants, Columbia

29406

Lowcountry Lung Critical Care, North Charleston

30328

Neurotrials Research Inc., Atlanta

32789

Florida Pediatric Research Institute, Winter Park

33511

Meris Clinical Research, Brandon

33765

St. Francis Medical Institute, Clearwater

38018

Neurology Clinic, P.C., Cordova

43017

Ohio Sleep Medicine and Neuroscience Institue, Dublin

44130

North Star Medical Research, Middleburg

44718

NeuroScience Research Center, LLC, Canton

45245

Intrepid Research, LLC, Cincinnati

48314

Clinical Neurophysiology Services, Sterling Heights

49008

Western Michigan University Homer Stryker MD School of Medicine, Kalamazoo

53719

University of Wisconsin-Madison, Madison

60026

NorthShore University Health System, Glenview

61637

OSF HealthCare Saint Francis Medical Center, Peoria

63017

St. Luke's Sleep Medicine and Research Center, Chesterfield

63123

Clayton Sleep Institute, St Louis

69101

Great Plains Health, North Platte

77375

Northwest Houston Neurology and Sleep, Tomball

77478

Comprehensive Sleep Medicine Associates, Sugar Land

78681

Central Texas Neurology Consultants, PA, Round Rock

78731

FutureSearch Trials of Neurology LP, Austin

90048

Cedars-Sinai Medical Towers, Los Angeles

94583

Sleep Medicine Specialists of California, San Ramon

07753

Sleep Dynamics, Neptune City

All Listed Sponsors
lead

Harmony Biosciences Management, Inc.

INDUSTRY