A Study of Pitolisant in Patients With Prader-Willi Syndrome

PHASE3RecruitingINTERVENTIONAL
Enrollment

134

Participants

Timeline

Start Date

May 28, 2024

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2027

Conditions
Prader-Willi Syndrome
Interventions
DRUG

Pitolisant tablet

Pitolisant tablet

OTHER

Placebo tablet

Placebo tablet

Trial Locations (58)

10467

RECRUITING

Montefiore Medical Center, The Bronx

11219

RECRUITING

Maimonides Medical Center, Brooklyn

21224

RECRUITING

Johns Hopkins Hospital, Baltimore

27560

RECRUITING

Science 37 (at-home option), Morrisville

30318

WITHDRAWN

Atlanta Diabetes Associates, Atlanta

30322

RECRUITING

Emory University School of Medicine, Atlanta

30329

WITHDRAWN

Rare Disease Research, Atlanta

45212

WITHDRAWN

CTI Clinical Research Center, Cincinnati

46202

RECRUITING

Riley Children's Hospital, Indianapolis

53226

RECRUITING

Childrens Hospital of Wisconsin, Milwaukee

55905

RECRUITING

Mayo Clinic-PPDS, Rochester

60611

RECRUITING

Ann And Robert H Lurie Children's Hospital of Chicago, Chicago

77030

RECRUITING

Texas Children's Hospital, Houston

78596

TERMINATED

Texas Valley Clinical Research, Weslaco

80045

RECRUITING

Colorado Children's Hospital, Aurora

90025

RECRUITING

Santa Monica Clinical Trials, Los Angeles

92123

RECRUITING

Rady Children's Hospital - Scan Diego, San Diego

94583

RECRUITING

Tri-Valley Sleep Center, San Ramon

441016

RECRUITING

Center for Human Genetics, Cleveland

95821-2123

RECRUITING

Center of Excellence in Diabetes and Endocrinology, Sacramento

19803-3607

RECRUITING

Nemours Children's Hospital, Wilmington

78249-3539

RECRUITING

Road Runner Research, San Antonio

Unknown

RECRUITING

Queensland Children's Hospital, Brisbane

RECRUITING

Royal Prince Alfred Hospital, Camperdown

RECRUITING

Sydney Children's Hospital, Randwick

RECRUITING

Children's Hospital at Westmead, Westmead

RECRUITING

UZ Brussels, Jette

RECRUITING

AMNDX Inc., Thornhill

RECRUITING

Jodha Tishon Inc., Toronto

RECRUITING

Vseobecna Fakultni Nemocnice V Praze-U Nemocnice 499/2, Prague

RECRUITING

Aarhus University Hospital, Aarhus

RECRUITING

Rigshospitalet, Copenhagen

RECRUITING

CHU d'Angers, Angers

RECRUITING

CHU de Toulouse-Hôpital Des Enfants, Toulouse

RECRUITING

University Hospital Essen, Essen

RECRUITING

Azienda Ospedaliero Universitaria A Meyer, Florence

RECRUITING

Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN, Genova

RECRUITING

Ospedale San Raffaele S.r.l. - PPDS, Milan

NOT_YET_RECRUITING

Azienda Ospedaliero Universitaria Di Modena Policlinico, Modena

RECRUITING

Azienda Ospedale Università Padova - Dipartimento Salute della Donna e del Bambino - INCIPIT - PIN, Padua

NOT_YET_RECRUITING

Ospedale Pediatrico Bambino Gesù IRCCS, Roma

RECRUITING

IRCCS Materno Infantile Burlo Garofolo - INCIPIT - PIN, Trieste

RECRUITING

Samodzielny Publiczny Szpital Kliniczny, Szczecin

RECRUITING

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu-Chalubinskiego 2-2a, Wroclaw

RECRUITING

Institutul National de Endocrinologie C. I. Parhon, Bucharest

RECRUITING

Institutul National de Endocrinologie C. I. Parhon, Bucharest

RECRUITING

"National Clinical Center for Children Neurorehabilitation Dr. Nicolae Robanescu", Bucharest

RECRUITING

Louis Turcanu Emergency Clinical Hospital for Children, Timișoara

RECRUITING

Corporacio Sanitaria Parc Tauli, Sabadell

WITHDRAWN

Hospital Universitario de Fuenlabrada, Fuenlabrada

RECRUITING

Hospital Sant Joan de Deu, Barcelona

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

RECRUITING

Universitario Virgen de la Victoria, Málaga

RECRUITING

Karolinska Universitetssjukhuset Solna, Solna

RECRUITING

Fulbourn Hospital, Cambridge

RECRUITING

Hull Royal Infirmary, Hull

RECRUITING

Ninewells Hospital - PPDS, Dundee

NOT_YET_RECRUITING

Royal Hospital for Children and Young People, Edinburgh

All Listed Sponsors
lead

Harmony Biosciences Management, Inc.

INDUSTRY