[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603808":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":34,"studyPopulation":27,"armGroups":35,"interventions":42,"overallOfficials":47,"centralContacts":51,"locations":61,"responsibleParty":81,"collaborators":27,"id":83,"slug":27,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":27,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":27,"enrollmentInfo":91,"targetDuration":27,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":64,"whyStopped":27,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Supernus Pharmaceuticals, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of treatment-emergent adverse events","The percent of participants who took at least one dose of SPN-817 and reported at least one adverse event during the 1-year SPN-817 Treatment Period","Week 1-Week 52",[14,18,21,24],{"measure":15,"description":16,"timeFrame":17},"Percent change (PCH) from baseline in quantifiable focal onset seizure frequency per 28 days over the 1-year SPN-817 Treatment Period","Percent change in 28-day frequency of quantifiable focal seizures during the 1-year Treatment Period relative to baseline","Baseline and Treatment Period (Week 1-52)",{"measure":19,"description":20,"timeFrame":17},"Proportion of participants experiencing ≥50% reduction in focal seizure frequency per 28 days from baseline","Greater than or equal to 50% reduction in 28-day frequency of focal seizures during the 1-year Treatment Period relative to baseline.",{"measure":22,"description":23,"timeFrame":17},"Proportion of participants experiencing seizure freedom","100% reduction in 28-day frequency of focal seizures during the Treatment Period relative to baseline",{"measure":25,"description":26,"timeFrame":12},"Percentage of seizure-free days over the 1-year SPN-817 Treatment Period","The number of seizure-free days reported for each participant divided by the total number of days with seizure data reported, multiplied by 100.",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":27,"primaryPurpose":31,"observationalModel":27,"timePerspective":27,"maskingInfo":32},"NA","SINGLE_GROUP","TREATMENT",{"masking":33,"maskingDescription":27,"whoMasked":27},"NONE","This is a Phase 2b, multicenter, open-label extension, one-year, safety, tolerability, and efficacy study in adults who previously completed an applicable double-blind SPN-817 clinical study. This study will include a double-blind Dose Titration\u002FBridging Period of 8-10 weeks in which SPN-817 will be titrated to the participant's maximum tolerated dose based on response. Following the Dose Titration\u002FBridging Period, participants will enter an Open Label Extension (OLE) Period of 42-44 weeks. When participants finish the OLE Period, they will initiate a Tapering Period (up to 4 weeks) followed by an End-of-Tapering Period video contact (VC) after the last dose of study drug. The duration of study treatment before starting the 4-week Tapering Period will be one year (52 weeks).",[36],{"label":37,"type":38,"description":39,"interventionNames":40},"SPN-817","EXPERIMENTAL","SPN-817, bid",[41],"Drug: SPN-817",[43],{"type":44,"name":37,"description":45,"armGroupLabels":46,"otherNames":27},"DRUG","SPN-817 starting at 0.25 mg bid up to 4.00 mg bid",[37],[48],{"name":49,"affiliation":5,"role":50},"Maciej Gasior, MD, PhD","STUDY_DIRECTOR",[52,57],{"name":53,"role":54,"phone":55,"phoneExt":27,"email":56},"Supernus Clinical Trials","CONTACT","240-403-5838","clinicaltrials@supernus.com",{"name":58,"role":54,"phone":59,"phoneExt":27,"email":60},"Navid Saeidi, MS","240-403-5328","nsaeidi@supernus.com",[62],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Medsol Clinical Research Center","RECRUITING","Port Charlotte","Florida","33952","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-82.09064,26.97617,{"lat":74,"lon":73},[77],{"name":78,"role":54,"phone":79,"phoneExt":27,"email":80},"Maria Vasconcelos, RN","941-623-9744","mvasconcelos@medsolcrc.com",{"type":82,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","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":92,"type":93},100,"ESTIMATED","INTERVENTIONAL",[96],"PHASE2","This is a Phase 2b open-label extension study to evaluate the long-term safety and efficacy of SPN-817.",[99],"Focal Onset Seizures",[101,102,103,104],"focal seizures","focal epilepsy","open-label extension","anti-seizure medication","2025-10-06",{"date":107,"type":108},"2025-10-10","ACTUAL",{"date":110,"type":108},"2025-07-30",{"date":112,"type":93},"2027-12-31",{"name":5,"class":6},1]