A Phase 2 Study to Evaluate the Safety and Efficacy of Pitolisant in Patients With Prader-Willi Syndrome, Followed by an Open Label Extension

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

December 9, 2020

Primary Completion Date

August 17, 2022

Study Completion Date

September 7, 2028

Conditions
Prader-Willi Syndrome
Interventions
DRUG

Pitolisant oral tablets

Pitolisant 4.45 mg or 17.8 mg tablets

DRUG

Placebo oral tablet

Matching placebo tablets

Trial Locations (13)

19803

Nemours Alfred I duPont Hospital for Children, Wilmington

21205

Johns Hopkins School of Medicine, Baltimore

32608

University of Florida College of Medicine, Gainesville

37203

Vanderbilt University Medical Center, Nashville

45212

CTI, Cincinnati

60611

Ann and Robert H Lurie Children's Hospital, Chicago

68114

University of Nebraska Medical Center, Omaha

77030

Texas Children's Hospital/Baylor College of Medicine, Houston

78249

Road Runner Research, San Antonio

80045

Children's Hospital Colorado, Aurora

90404

Santa Monica Clinical Trials, Santa Monica

92123

Rady Children's Hospital - San Diego, San Diego

94583

Sleep Medicine Specialists of California, San Ramon

All Listed Sponsors
lead

Harmony Biosciences Management, Inc.

INDUSTRY