[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603808":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":34,"responsibleParty":54,"collaborators":19,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":19,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":19,"enrollmentInfo":65,"targetDuration":19,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":37,"whyStopped":19,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Supernus Pharmaceuticals, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SPN-817","EXPERIMENTAL","SPN-817, bid",[13],"Drug: SPN-817",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","SPN-817 starting at 0.25 mg bid up to 4.00 mg bid",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Maciej Gasior, MD, PhD","STUDY_DIRECTOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Supernus Clinical Trials","CONTACT","240-403-5838","clinicaltrials@supernus.com",{"name":31,"role":27,"phone":32,"phoneExt":19,"email":33},"Navid Saeidi, MS","240-403-5328","nsaeidi@supernus.com",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Medsol Clinical Research Center","RECRUITING","Port Charlotte","Florida","33952","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-82.09064,26.97617,{"lat":47,"lon":46},[50],{"name":51,"role":27,"phone":52,"phoneExt":19,"email":53},"Maria Vasconcelos, RN","941-623-9744","mvasconcelos@medsolcrc.com",{"type":55,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100603808","phase-2-spn-817-open-label-extension-study-in-adults-with-focal-onset-seizures-100603808",false,"NCT07141329","SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures","An Open-Label Extension, One-Year, Safety, and Efficacy Study of SPN-817 in Adults With Focal Onset Seizures","Inclusion Criteria:\n\n1. Completed antecedent SPN-817 double-blind study\n2. Taking a stable dosage regimen (maintained during the antecedent study) of at least one antiseizure medication (ASM) and no more than 4 ASMs\n\nExclusion Criteria:\n\n1. Has current nonepileptic events that could be confused by the participant and\u002For study staff as epileptic seizures\n2. Has any suicidal behavior or suicidal ideation related to Item 4 (active suicidal ideation with some intent to act without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) based on the Columbia-Suicide Severity Rating Scale (C-SSRS) assessments in the antecedent study and at Visit 1 or more than one lifetime suicide attempt.","ALL","18 Years",{"count":66,"type":67},100,"ESTIMATED","INTERVENTIONAL",[70],"PHASE2","This is a Phase 2b open-label extension study to evaluate the long-term safety and efficacy of SPN-817.",[73],"Focal Onset Seizures",[75,76,77,78],"focal seizures","focal epilepsy","open-label extension","anti-seizure medication","2025-10-06",{"date":81,"type":82},"2025-10-10","ACTUAL",{"date":84,"type":82},"2025-07-30",{"date":86,"type":67},"2027-12-31",{"name":5,"class":6},1]