[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547857":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":10,"centralContacts":43,"locations":49,"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":93,"overallStatus":52,"whyStopped":10,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Axsome Therapeutics, Inc.","INDUSTRY",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA",null,"Pregnant women with a diagnosis of narcolepsy or OSA",[13],"Drug: Sunosi (solriamfetol)",{"label":15,"type":10,"description":11,"interventionNames":16},"Cohort 2: Unexposed participants with narcolepsy or OSA",[17],"Other: No treatment",{"label":19,"type":10,"description":11,"interventionNames":20},"Cohort 3: Other-exposed participants with narcolepsy or OSA",[21],"Drug: Other prescription wake-promoting medications or stimulants",{"label":23,"type":10,"description":24,"interventionNames":25},"Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSA","Pregnant women without a diagnosis of narcolepsy or OSA",[13],{"label":27,"type":10,"description":24,"interventionNames":28},"Cohort 5: Other-exposed participants without narcolepsy or OSA",[21],[30,35,39],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"DRUG","Sunosi (solriamfetol)","Exposure to at least 1 dose of solriamfetol at any time during pregnancy.",[9,23],{"type":31,"name":36,"description":37,"armGroupLabels":38,"otherNames":10},"Other prescription wake-promoting medications or stimulants","Exposure to at least 1 dose of a prescription wake-promoting medication or stimulant at any time during pregnancy.",[19,27],{"type":40,"name":41,"description":41,"armGroupLabels":42,"otherNames":10},"OTHER","No treatment",[15],[44],{"name":45,"role":46,"phone":47,"phoneExt":10,"email":48},"Study Director","CONTACT","1-877-283-6220","sunosipregnancyregistry@ppd.com",[50,64],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":10},"Evidera, a PPD business unit","RECRUITING","Morrisville","North Carolina","27560","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-78.82556,35.82348,{"lat":62,"lon":61},{"facility":65,"status":52,"city":66,"state":54,"zip":67,"country":56,"countryCode":57,"cosmosGeoPoint":68,"geoPoint":72,"contacts":10},"PPD, Inc.","Wilmington","28401",{"type":59,"coordinates":69},[70,71],-77.94604,34.23556,{"lat":71,"lon":70},{"type":74,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100547857","sunosi-solriamfetol-pregnancy-registry-100547857",false,"NCT06413420","SUNOSI® (Solriamfetol) Pregnancy Registry","SUNOSI® (Solriamfetol) Pregnancy Registry: An Observational Study on the Safety of Solriamfetol Exposure in Pregnant Women and Their Offspring","Inclusion Criteria:\n\n* Pregnant women of any age\n* Diagnosed with narcolepsy or obstructive sleep apnea OR has taken solriamfetol or other wake promoting medications or stimulants during pregnancy\n* Resident of a country where solriamfetol is available for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy or OSA\n* Provides written informed consent to participate in the study\n* Authorization for her HCP(s) to provide data to the registry\n\nExclusion Criteria:\n\n* Occurrence of pregnancy outcome prior to first contact with the registry coordination center (RCC)\n* Inclusion of a prior pregnancy in the main analysis population","FEMALE",{"count":84,"type":85},1731,"ESTIMATED","12 Months","OBSERVATIONAL","The SUNOSI (solriamfetol) Pregnancy Registry is a prospective, multi-country, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep apnea (OSA).",[90,91,92],"Narcolepsy","Obstructive Sleep Apnea","Pregnant Women and Their Offspring",[94,95,96,90,91,97,98,99,100],"Solriamfetol","SUNOSI","Axsome","Non-stimulant therapy","Dopamine norepinephrine reuptake inhibitor","Pregnancy outcomes","Infant outcomes","2024-05-09",{"date":103,"type":104},"2024-05-14","ACTUAL",{"date":106,"type":104},"2019-07-31",{"date":108,"type":85},"2029-09",{"name":5,"class":6},2]