New hope for managing key symptoms in rare genetic disorder

NCT ID NCT06366464

Summary

This study is testing whether a medication called pitolisant can help reduce excessive daytime sleepiness and improve difficult behaviors in people aged 6 and older with Prader-Willi syndrome. About 134 participants will be randomly assigned to receive either the real medication or a placebo pill for 11 weeks, with an option to continue on the real medication afterward. The main goal is to see if pitolisant safely makes patients less sleepy during the day and also helps with issues like irritability and extreme hunger.

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Contacts and locations

Study contacts

  • Contact

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Locations

  • AMNDX Inc.

    RECRUITING

    Thornhill, Ontario, Canada

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  • Aarhus University Hospital

    RECRUITING

    Aarhus, Denmark

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

    RECRUITING

    Chicago, Illinois, 60611, United States

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  • Atlanta Diabetes Associates

    WITHDRAWN

    Atlanta, Georgia, 30318, United States

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

    RECRUITING

    Padua, Italy

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  • Azienda Ospedaliero Universitaria A Meyer

    RECRUITING

    Florence, Italy

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  • CHU d'Angers

    RECRUITING

    Angers, France

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  • CHU de Toulouse-Hôpital Des Enfants

    RECRUITING

    Toulouse, France

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  • CTI Clinical Research Center

    WITHDRAWN

    Cincinnati, Ohio, 45212, United States

  • Center for Human Genetics

    RECRUITING

    Cleveland, Ohio, 441016, United States

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  • Center of Excellence in Diabetes and Endocrinology

    RECRUITING

    Sacramento, California, 95821-2123, United States

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  • Children's Hospital at Westmead

    RECRUITING

    Westmead, Australia

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  • Childrens Hospital of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

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  • Colorado Children's Hospital

    RECRUITING

    Aurora, Colorado, 80045, United States

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  • Corporacio Sanitaria Parc Tauli, Sabadell

    RECRUITING

    Barcelona, Spain

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  • Emory University School of Medicine

    RECRUITING

    Atlanta, Georgia, 30322, United States

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  • Fulbourn Hospital

    RECRUITING

    Cambridge, England, United Kingdom

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  • Hospital Sant Joan de Deu

    RECRUITING

    Barcelona, Spain

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  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, Spain

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  • Hull Royal Infirmary

    RECRUITING

    Hull, England, United Kingdom

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  • IRCCS Materno Infantile Burlo Garofolo - INCIPIT - PIN

    RECRUITING

    Trieste, Italy

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  • Institutul National de Endocrinologie C. I. Parhon

    RECRUITING

    Bucharest, Romania

  • Institutul National de Endocrinologie C. I. Parhon

    RECRUITING

    Bucharest, Romania

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  • Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN

    RECRUITING

    Genova, Italy

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  • Jodha Tishon Inc.

    RECRUITING

    Toronto, Ontario, Canada

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  • Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21224, United States

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  • Karolinska Universitetssjukhuset Solna

    RECRUITING

    Solna, Sweden

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  • Louis Turcanu Emergency Clinical Hospital for Children

    RECRUITING

    Timișoara, Romania

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  • Maimonides Medical Center

    RECRUITING

    Brooklyn, New York, 11219, United States

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  • Mayo Clinic-PPDS

    RECRUITING

    Rochester, Minnesota, 55905, United States

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  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

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  • National Clinical Center for Children Neurorehabilitation "Dr. Nicolae Robanescu"

    RECRUITING

    Bucharest, Romania

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  • Nemours Children's Hospital

    RECRUITING

    Wilmington, Delaware, 19803-3607, United States

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  • Ninewells Hospital - PPDS

    RECRUITING

    Dundee, Scotland, United Kingdom

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  • Ospedale Pediatrico Bambino Gesù IRCCS

    RECRUITING

    Roma, Italy

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  • Ospedale San Raffaele S.r.l. - PPDS

    RECRUITING

    Milan, Italy

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  • Queensland Children's Hospital

    RECRUITING

    Brisbane, Queensland, Australia

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  • Rady Children's Hospital - Scan Diego

    RECRUITING

    San Diego, California, 92123, United States

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  • Rare Disease Research

    WITHDRAWN

    Atlanta, Georgia, 30329, United States

  • Rigshospitalet

    RECRUITING

    Copenhagen, Denmark

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  • Riley Children's Hospital

    RECRUITING

    Indianapolis, Indiana, 46202, United States

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  • Road Runner Research

    RECRUITING

    San Antonio, Texas, 78249-3539, United States

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  • Royal Hospital for Children and Young People

    RECRUITING

    Edinburgh, Scotland, United Kingdom

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  • Royal Prince Alfred Hospital

    RECRUITING

    Camperdown, Australia

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  • Samodzielny Publiczny Szpital Kliniczny

    RECRUITING

    Szczecin, Poland

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  • Santa Monica Clinical Trials

    RECRUITING

    Los Angeles, California, 90025, United States

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  • Science 37 (at-home option)

    RECRUITING

    Morrisville, North Carolina, 27560, United States

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  • Sydney Children's Hospital

    RECRUITING

    Randwick, Australia

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  • Texas Children's Hospital

    RECRUITING

    Houston, Texas, 77030, United States

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  • Texas Valley Clinical Research

    TERMINATED

    Weslaco, Texas, 78596, United States

  • UZ Brussels

    RECRUITING

    Jette, Belgium

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  • Universitario Virgen de la Victoria

    RECRUITING

    Málaga, Spain

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  • University Hospital Essen

    RECRUITING

    Essen, Germany

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

    RECRUITING

    Wroclaw, Poland

    Contact Email: •••••@•••••

    Contact

Conditions

Explore the condition pages connected to this study.