New hope for sleepiness in Prader-Willi syndrome: drug trial underway
NCT ID NCT06366464
First seen Nov 01, 2025 · Last updated May 14, 2026 · Updated 26 times
Summary
This study tests a drug called pitolisant to see if it can reduce severe daytime sleepiness in people with Prader-Willi syndrome, a genetic condition. About 134 participants aged 6 and older will receive either the drug or a placebo, and then all will have the option to take the drug in an open-label extension. The trial also looks at effects on behavior and appetite-related issues.
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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Study contacts
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AMNDX Inc.
RECRUITINGThornhill, Ontario, Canada
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Aarhus University Hospital
RECRUITINGAarhus, Denmark
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Ann And Robert H Lurie Children's Hospital of Chicago
RECRUITINGChicago, Illinois, 60611, United States
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Atlanta Diabetes Associates
WITHDRAWNAtlanta, Georgia, 30318, United States
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Azienda Ospedale Università Padova - Dipartimento Salute della Donna e del Bambino - INCIPIT - PIN
RECRUITINGPadova, Italy
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Azienda Ospedaliero Universitaria A Meyer
RECRUITINGFlorence, Italy
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CHU d'Angers
RECRUITINGAngers, France
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CHU de Toulouse-Hôpital Des Enfants
RECRUITINGToulouse, France
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CTI Clinical Research Center
WITHDRAWNCincinnati, Ohio, 45212, United States
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Center for Human Genetics
RECRUITINGCleveland, Ohio, 441016, United States
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Center of Excellence in Diabetes and Endocrinology
RECRUITINGSacramento, California, 95821-2123, United States
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Children's Hospital at Westmead
RECRUITINGWestmead, Australia
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Childrens Hospital of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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Colorado Children's Hospital
RECRUITINGAurora, Colorado, 80045, United States
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Corporacio Sanitaria Parc Tauli, Sabadell
RECRUITINGBarcelona, Spain
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Emory University School of Medicine
RECRUITINGAtlanta, Georgia, 30322, United States
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Fulbourn Hospital
RECRUITINGCambridge, England, United Kingdom
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Hospital Sant Joan de Deu
RECRUITINGBarcelona, Spain
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Hospital Universitario 12 de Octubre
RECRUITINGMadrid, Spain
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Hull Royal Infirmary
RECRUITINGHull, England, United Kingdom
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IRCCS Materno Infantile Burlo Garofolo - INCIPIT - PIN
RECRUITINGTrieste, Italy
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Institutul National de Endocrinologie C. I. Parhon
RECRUITINGBucharest, Romania
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Institutul National de Endocrinologie C. I. Parhon
RECRUITINGBucharest, Romania
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Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN
RECRUITINGGenova, Italy
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Jodha Tishon Inc.
RECRUITINGToronto, Ontario, Canada
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Johns Hopkins Hospital
RECRUITINGBaltimore, Maryland, 21224, United States
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Karolinska Universitetssjukhuset Solna
RECRUITINGSolna, Sweden
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Louis Turcanu Emergency Clinical Hospital for Children
RECRUITINGTimișoara, Romania
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Maimonides Medical Center
RECRUITINGBrooklyn, New York, 11219, United States
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Mayo Clinic-PPDS
RECRUITINGRochester, Minnesota, 55905, United States
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Montefiore Medical Center
RECRUITINGThe Bronx, New York, 10467, United States
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National Clinical Center for Children Neurorehabilitation "Dr. Nicolae Robanescu"
RECRUITINGBucharest, Romania
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Nemours Children's Hospital
RECRUITINGWilmington, Delaware, 19803-3607, United States
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Ninewells Hospital - PPDS
RECRUITINGDundee, Scotland, United Kingdom
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Ospedale Pediatrico Bambino Gesù IRCCS
RECRUITINGRoma, Italy
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Ospedale San Raffaele S.r.l. - PPDS
RECRUITINGMilan, Italy
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Queensland Children's Hospital
RECRUITINGBrisbane, Queensland, Australia
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Rady Children's Hospital - Scan Diego
RECRUITINGSan Diego, California, 92123, United States
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Rare Disease Research
WITHDRAWNAtlanta, Georgia, 30329, United States
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Rigshospitalet
RECRUITINGCopenhagen, Denmark
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Riley Children's Hospital
RECRUITINGIndianapolis, Indiana, 46202, United States
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Road Runner Research
RECRUITINGSan Antonio, Texas, 78249-3539, United States
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Royal Hospital for Children and Young People
RECRUITINGEdinburgh, Scotland, United Kingdom
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Royal Prince Alfred Hospital
RECRUITINGCamperdown, Australia
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Samodzielny Publiczny Szpital Kliniczny
RECRUITINGSzczecin, Poland
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Santa Monica Clinical Trials
RECRUITINGLos Angeles, California, 90025, United States
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Science 37 (at-home option)
RECRUITINGMorrisville, North Carolina, 27560, United States
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Sydney Children's Hospital
RECRUITINGRandwick, Australia
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Texas Children's Hospital
RECRUITINGHouston, Texas, 77030, United States
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Texas Valley Clinical Research
TERMINATEDWeslaco, Texas, 78596, United States
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UZ Brussels
RECRUITINGJette, Belgium
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Universitario Virgen de la Victoria
RECRUITINGMálaga, Spain
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University Hospital Essen
RECRUITINGEssen, Germany
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Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu-Chalubinskiego 2-2a
RECRUITINGWroclaw, Poland
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Conditions
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