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PPDS","Dundee","Scotland",{"type":54,"coordinates":784},[785,786],-2.97489,56.46913,{"lat":786,"lon":785},[789,792],{"name":790,"role":40,"phone":36,"phoneExt":36,"email":791},"Clare Webster, MD","clare.webster@nhs.scot",{"name":790,"role":66,"phone":36,"phoneExt":36,"email":36},{"facility":794,"status":48,"city":795,"state":782,"zip":36,"country":755,"cosmosGeoPoint":796,"geoPoint":800,"contacts":801},"Royal Hospital for Children and Young People","Edinburgh",{"type":54,"coordinates":797},[798,799],-3.19648,55.95206,{"lat":799,"lon":798},[802,805],{"name":803,"role":40,"phone":36,"phoneExt":36,"email":804},"Kathryn Cox, MD","kathryn.cox@nhslothian.scot.nhs.uk",{"name":803,"role":66,"phone":36,"phoneExt":36,"email":36},{"type":807,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100544252",false,"NCT06366464","A Study of Pitolisant in Patients With Prader-Willi Syndrome","A Phase 3, Randomized, Double-Blind, Placebo-controlled, Efficacy and Safety Study of Pitolisant Followed by an Open-Label Extension in Patients With Prader-Willi Syndrome","Inclusion Criteria:\n\n* Genetically confirmed diagnosis of PWS\n* Excessive daytime sleepiness\n* Has a consistent parent\u002Fcaregiver (preferably the same person throughout the study) who is willing and able to complete the required study assessments.\n* In the opinion of the Investigator, the patient\u002Fparent(s)\u002Fcaregiver(s)\u002Flegal guardian(s) are capable of understanding and complying with the requirements of the protocol and administration of oral study drug.\n\nExclusion Criteria:\n\n* Has a diagnosis of sleep apnea (OSA, CSA) that is not adequately controlled\n* Has a diagnosis of hypersomnia due to another sleep\u002Fmedical disorder\n* Participation in an interventional research study involving another investigational medication, device, or behavioral treatment within 30 days or 5 half-lives (whichever is longer) of the investigational medication prior to Screening","ALL","6 Years",{"count":817,"type":818},134,"ESTIMATED","INTERVENTIONAL",[821],"PHASE3","This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome.\n\nThe primary objective of this study is to evaluate the efficacy of pitolisant in treating excessive daytime sleepiness (EDS) in patients ≥6 years of age with Prader-Willi syndrome.\n\nSecondary objectives include assessing the impact of pitolisant on:\n\nIrritable and disruptive behaviors Hyperphagia Other behavioral problems including social withdrawal, stereotypic behavior, hyperactivity\u002Fnoncompliance, and inappropriate speech",[824],"Prader-Willi Syndrome",[30,826,827,828],"excessive daytime sleepiness","irritable and disruptive behaviors","Prader-Willi syndrome","2026-03-13",{"date":831,"type":832},"2026-03-17","ACTUAL",{"date":834,"type":832},"2024-05-28",{"date":836,"type":818},"2027-07",{"name":5,"class":6},54]