[{"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":93},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100577484","phase-2-renaissance-2-spn-817-phase-2-double-blind-placebo-controlled-study-in-adults-with-focal-onset-seizures-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":20,"type":21},216,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Focal Onset Seizures",[29,30,31,32],"focal seizures","focal epilepsy","Phase 2","anti-seizure medication","RECRUITING","2026-05-28",{"date":36,"type":37},"2026-06-01","ACTUAL",{"date":39,"type":37},"2024-12-30",{"date":41,"type":21},"2027-08",{"name":43,"class":44},"Supernus Pharmaceuticals, Inc.","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100494278","phase-3-a-randomized-study-of-xen1101-versus-placebo-in-focal-onset-seizures-x-tole3-100494278","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":54,"type":21},360,[56],"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.",[27],[60],"Epilepsy","2026-05-12",{"date":63,"type":37},"2026-05-14",{"date":65,"type":37},"2023-05-09",{"date":67,"type":21},"2026-12",{"name":69,"class":44},"Xenon Pharmaceuticals Inc.",95,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":45},"100603808","phase-2-spn-817-open-label-extension-study-in-adults-with-focal-onset-seizures-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":79,"type":21},100,[24],"This is a Phase 2b open-label extension study to evaluate the long-term safety and efficacy of SPN-817.",[27],[29,30,84,32],"open-label extension","2025-10-06",{"date":87,"type":37},"2025-10-10",{"date":89,"type":37},"2025-07-30",{"date":91,"type":21},"2027-12-31",{"name":43,"class":44},"Focal-Onset Seizures"]