[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"focal-onset-seizures\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:focal-onset-seizures":90},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,69],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100577484",false,"NCT06798896","RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures","RENAISSANCE 2: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of SPN-817 in Adults With Focal Onset Seizures","Inclusion Criteria:\n\n1. Diagnosis of treatment-resistant focal epilepsy as adjudicated by the Epilepsy Study Consortium, Inc (ESCI);\n2. Failed to achieve sustained seizure freedom after ≥2 tolerated, appropriately chosen, and adequately dosed ASM drug schedules;\n3. Able to keep accurate Seizure electronic diaries \\[eDiaries\\] (with the aid of a caregiver as needed);\n4. Has a body mass index (BMI) between 18.0 and 40.0 kg\u002Fm2;\n5. Treatment with a stable dose of 1 to 4 current ASMs for ≥28 days prior to screening. If following a diet plan along with the ASM, the participant should have been on a stable diet plan for at least 1 month prior to Visit 1. The diet plan should be maintained throughout the duration of the study;\n6. At least 4 clinically observable focal onset seizures accepted by the ESCI prior to the first dose of SM (during the days of baseline Seizure electronic diary \\[eDiary\\] data collection) and no more than a consecutive 21-day period that was free of these seizures. To be eligible for the study, participants must comply with the eDiary on at least 80% of the days of baseline data collection;\n\nExclusion Criteria:\n\n1. Has taken huperzine A within the past 6 months;\n2. Prior diagnosis of combined focal and generalized epilepsy syndrome as evidenced by severe developmental delay and multiple seizure types and confirmed by electroencephalography (EEG) (eg, Lennox-Gastaut syndrome). Participants should also be excluded in case of nondiagnostic information;\n3. History of or current nonepileptic events that could be confused by the participant and\u002For study staff as epileptic seizures;\n4. Only has seizures that are difficult to count; for example, seizures that are not clinically observable;\n5. History of uncountable seizures, such as seizures that happen in a cluster that are too rapid to be counted individually;\n6. History of status epilepticus within 6 months prior to screening;\n7. Vagus nerve stimulation, deep brain stimulation, responsive neurostimulator system, or other neurostimulation for epilepsy device implanted or activated within 1 year prior to screening; or epilepsy surgery within 1 year prior to screening. Stimulation parameters for devices must have been stable for at least 3 months prior to Screening. Battery change for any epilepsy devices will be allowed; however, stimulation parameters must remain stable during the duration of the study;\n8. 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 C-SSRS assessment in the 1 year before screening; a suicide attempt in the last 2 years before screening; or more than 1 lifetime suicide attempt;\n9. Chronic concomitant therapy with non-ASMs that have potent cholinergic (central or peripheral) or potent central (only) anticholinergic pharmacology.\n10. History of \\>2 allergic reactions to an ASM or 1 serious hypersensitivity reaction to an ASM;\n11. Any other reason which, in the opinion of the Investigator, would prevent the participant from taking part in the study.","ALL","18 Years","70 Years",{"count":19,"type":20},216,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a Phase 2 double-blind, randomized, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy, safety, and tolerability of SPN-817 in adults with focal onset seizures.",[26],"Focal Onset Seizures",[28,29,30,31],"focal seizures","focal epilepsy","Phase 2","anti-seizure medication","RECRUITING","2026-05-28",{"date":35,"type":36},"2026-06-01","ACTUAL",{"date":38,"type":36},"2024-12-30",{"date":40,"type":20},"2027-08",{"name":42,"class":43},"Supernus Pharmaceuticals, Inc.","INDUSTRY",1,{"id":46,"slug":4,"hasResults":10,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100494278","NCT05716100","A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)","A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures","Inclusion Criteria:\n\n* Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study\n* Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017). Subject must have had adequate trials of at least 2 ASMs, which were given (and tolerated) at adequate therapeutic doses, without achieving sustained seizure freedom.\n* Treatment with a stable dose of 1 to 3 allowable current ASMs for at least one month prior to screening, during baseline, and throughout the duration of the DBP\n* Able to keep accurate seizure diaries\n\nExclusion Criteria:\n\n* Previously documented electroencephalogram which shows any pattern not consistent with focal etiology of seizures.\n* History of focal aware non-motor seizures only, non-epileptic psychogenic seizure, primary generalized seizure, developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.\n* Seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive central nervous system (CNS) disease.\n* History of status epilepticus or repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.\n* History of neurosurgery for seizures \\\u003C1 year prior to Visit 1, or radiosurgery \\\u003C2 years prior to enrollment.\n* Any medical condition or personal circumstance that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study or prevents adherence to the protocol.",{"count":52,"type":20},360,[54],"PHASE3","The X-TOLE3 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.",[26],[58],"Epilepsy","2026-05-12",{"date":61,"type":36},"2026-05-14",{"date":63,"type":36},"2023-05-09",{"date":65,"type":20},"2026-12",{"name":67,"class":43},"Xenon Pharmaceuticals Inc.",95,{"id":70,"slug":4,"hasResults":10,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":80,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":44},"100603808","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.",{"count":76,"type":20},100,[23],"This is a Phase 2b open-label extension study to evaluate the long-term safety and efficacy of SPN-817.",[26],[28,29,81,31],"open-label extension","2025-10-06",{"date":84,"type":36},"2025-10-10",{"date":86,"type":36},"2025-07-30",{"date":88,"type":20},"2027-12-31",{"name":42,"class":43},""]