[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100480440":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":10,"centralContacts":49,"locations":55,"responsibleParty":73,"collaborators":10,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":10,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":10,"maxAge":10,"enrollmentInfo":83,"targetDuration":86,"studyType":87,"phases":10,"briefSummary":88,"conditions":89,"keywords":10,"overallStatus":58,"whyStopped":10,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Harmony Biosciences Management, Inc.","INDUSTRY",[8,14,17,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Pitolisant-exposed participants with narcolepsy",null,"Pregnant women with a diagnosis of narcolepsy who are exposed to pitolisant at any time during pregnancy",[13],"Drug: Pitolisant",{"label":15,"type":10,"description":16,"interventionNames":10},"Unexposed participants with narcolepsy","Pregnant women with a diagnosis of narcolepsy who are not exposed to pitolisant or a comparator product at any time during pregnancy",{"label":18,"type":10,"description":19,"interventionNames":20},"Comparator-exposed participants with narcolepsy","Pregnant women with a diagnosis of narcolepsy who are not exposed to pitolisant at any time during pregnancy but who are exposed to comparator products at any time during pregnancy",[21],"Drug: Comparator Products",{"label":23,"type":10,"description":24,"interventionNames":25},"Pitolisant-exposed participants without narcolepsy","Pregnant women without a diagnosis of narcolepsy who are exposed to pitolisant at any time during pregnancy",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Comparator-exposed participants without narcolepsy","Pregnant women without a diagnosis of narcolepsy who are not exposed to pitolisant at any time during pregnancy but who are exposed to a comparator product at any time during pregnancy",[21],[31,38],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Pitolisant","Exposure to at least one dose of pitolisant at any time during pregnancy",[9,23],[37],"Wakix",{"type":32,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Comparator Products","Exposure to at least one dose of a comparator product at any time during pregnancy",[18,27],[43,44,45,46,47,48],"Modafinil\u002Farmodafinil","Sodium oxybate","Oxybate mixed salts","Solriamfetol","Methylphenidate","Amphetamines",[50],{"name":51,"role":52,"phone":53,"phoneExt":10,"email":54},"WAKIX Pregnancy Registry Associate","CONTACT","1-877-302-2813","wakixpregnancyregistry@ppd.com",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Evidera (PPD)","RECRUITING","Morrisville","North Carolina","28403","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-78.82556,35.82348,{"lat":68,"lon":67},[71],{"name":72,"role":52,"phone":10,"phoneExt":10,"email":10},"Marielle Bassell, BA",{"type":74,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100480440","wakix-pitolisant-pregnancy-registry-100480440",false,"NCT05536011","WAKIX® (Pitolisant) Pregnancy Registry","WAKIX® (Pitolisant) Pregnancy Registry: An Observational Study of the Safety of Pitolisant Exposure in Pregnant Women and Their Offspring","Inclusion Criteria:\n\n* Pregnant woman of any age\n* Consent to participate\n* Authorization for her HCP(s) to provide data to the registry\n* For participants with a diagnosis of narcolepsy: exposure to at least one dose of pitolisant or one dose of a comparator product, or, unexposed to pitolisant or comparator products at any time during pregnancy (i.e., any pregnant woman with a diagnosis of narcolepsy)\n* For participants without a diagnosis of narcolepsy: exposure to at least one dose of pitolisant or one dose of a comparator product at any time during pregnancy\n\nExclusion Criterion:\n\n• Occurrence of pregnancy outcome prior to first contact with the Registry Coordination Center (RCC) (i.e., retrospectively enrolled)","FEMALE",{"count":84,"type":85},1329,"ESTIMATED","21 Months","OBSERVATIONAL","The WAKIX (pitolisant) Pregnancy Registry is a US-based, prospective, observational cohort study designed to evaluate the association between pitolisant exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.",[90,91],"Pregnancy Related","Narcolepsy","2026-06-10",{"date":94,"type":95},"2026-06-12","ACTUAL",{"date":97,"type":95},"2021-08-24",{"date":99,"type":85},"2030-06-30",{"name":5,"class":6},1]