[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-stroke-epilepsy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-stroke-epilepsy":61},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100639078","phase-3-edaravone-dexborneol-for-post-stroke-epilepsy-100639078",false,"NCT07604350","Edaravone Dexborneol for Post-Stroke Epilepsy","A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study of Edaravone Dexborneol Sublingual Tablets for the Prevention of Post-Stroke Epilepsy","EDEN-PSE","Inclusion criteria: 1. Adults aged 18 to 80 years, of either sex.\n\n2\\. Diagnosis of acute ischemic stroke confirmed by clinical presentation and neuroimaging (MRI or CT).\n\n3\\. Time from stroke onset to screening\u002Frandomization ≤48 hours.\n\n4\\. High risk of post-stroke epilepsy, defined as a SeLECT-EEG score ≥7, including: stroke severity (Se, 0-2 points), large-artery atherosclerosis etiology (L, 0-1 point), cortical involvement (C, 0-2 points), middle cerebral artery territory infarction (T, 0-1 point), and EEG findings (EEG, 0-2 points).\n\n5\\. No prior history of epilepsy before the index stroke, and no history of other central nervous system disorders (e.g., traumatic brain injury, brain tumor) associated with seizures.\n\n6\\. Conscious at enrollment or with recovered consciousness after treatment, and able to cooperate with sublingual medication administration and follow-up assessments.\n\n7\\. Provision of written informed consent by the patient or a legally authorized representative.\n\nExclusion criteria: 1. History of epilepsy or occurrence of any seizure prior to screening.\n\n2\\. History of ischemic or hemorrhagic stroke within 12 months prior to the index stroke.\n\n3\\. Large cerebral infarction with severe intracranial hypertension on imaging after stroke, with limited life expectancy or inability to complete follow-up.\n\n4\\. Severe renal impairment (significantly reduced eGFR according to contraindications of edaravone dexborneol) or a history of edaravone-related renal injury.\n\n5\\. Severe hepatic dysfunction (ALT or AST \\>3 times the upper limit of normal) or severe heart failure (New York Heart Association class III-IV) that may preclude tolerance to the study drug.\n\n6\\. Known hypersensitivity to edaravone or borneol, or a history of severe drug allergy.\n\n7\\. Pregnant or breastfeeding women; women of childbearing potential unwilling to use effective contraception.\n\n8\\. Presence of other serious diseases (e.g., advanced malignancy) that may affect survival or study compliance.\n\n9\\. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.","ALL","18 Years","80 Years",{"count":21,"type":22},160,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This is a prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial designed to evaluate the efficacy and safety of Edaravone Dexborneol sublingual tablets in preventing late-onset epilepsy in patients with acute ischemic stroke at high risk.\n\nEligible participants are adults aged 18-80 years with a confirmed diagnosis of acute ischemic stroke by clinical and imaging criteria (MRI or CT), enrolled within 48 hours of stroke onset. High risk for post-stroke epilepsy is defined as a SeLECT-EEG score ≥7. Patients must have no prior history of epilepsy or other central nervous system disorders associated with seizures. Key exclusion criteria include prior seizures before enrollment, recent stroke within the past 12 months, severe renal or hepatic dysfunction, significant cardiac insufficiency, drug hypersensitivity, pregnancy or lactation, and other conditions deemed unsuitable by investigators.\n\nA total of approximately 160 participants will be randomized in a 1:1 ratio to receive either Edaravone Dexborneol sublingual tablets or matching placebo.\n\nThe primary endpoint is a composite outcome assessed within 2 years, defined as the occurrence of either: (1) definite clinical epileptic seizures, or (2) new-onset or worsening epileptiform EEG abnormalities (including IEDs, PDs, LRDAs) or electrographic seizures.\n\nSecondary endpoints include: incidence of individual components of the primary outcome; time to first seizure; characteristics, severity, and frequency of seizures; longitudinal changes and resolution rate of epileptiform EEG activity; cognitive function assessed by MoCA and MMSE; neurological outcomes evaluated by mRS and NIHSS; quality of life and functional independence measured by SSQOL and Barthel Index; recurrence of stroke and all-cause mortality; changes in inflammatory biomarkers (TNF-α, IL-1β, COX-2, iNOS); and safety outcomes including treatment-emergent adverse events, serious adverse events, laboratory abnormalities, and treatment discontinuation due to adverse events.\n\nAll efficacy and safety outcomes will be independently reviewed by a blinded adjudication committee. Statistical analyses will include chi-square or Fisher's exact tests for categorical outcomes, Kaplan-Meier survival analysis with log-rank tests for time-to-event data, and Cox proportional hazards models to adjust for potential confounders.\n\nThe study period is planned from June 2026 to June 2030.",[28,29],"Post-stroke Epilepsy","Post-stroke Seizure",[31,32],"post-stroke epilepsy","edaravone dexborneol","NOT_YET_RECRUITING","2026-05-20",{"date":36,"type":37},"2026-05-22","ACTUAL",{"date":39,"type":22},"2026-06",{"date":41,"type":22},"2030-12",{"name":43,"class":44},"First Affiliated Hospital of Wenzhou Medical University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":57,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":65,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":78,"locationsCount":45},"100505681","predisposing-factors-for-post-stroke-epilepsy-100505681","NCT05864547","Predisposing Factors for Post-stroke Epilepsy","PRESTEP","Inclusion Criteria:\n\n* First time stroke patients with capacity to consent, admitted to the stroke unit at St. Olavs hospital.\n* Modified Rankin Scale (mRS) ≤ 2 before the stroke\n\nExclusion Criteria:\n\n* Previous stroke or brain surgery\n* Traumatic brain injuries\n* Neurodegenerative diseases\n* Brain tumors\n* Epilepsy before the stroke\n* Hydrocephalus\n* Aphasia\n* Serious psychiatric disorders\n* MRI incompatibility and claustrophobia",true,"85 Years",{"count":56,"type":22},30,"6 Months","OBSERVATIONAL","The goal of this observational study is to learn about epilepsy after a stroke (post-stroke epilepsy). The main questions it aims to answer are:\n\n* What make some patients develop epilepsy after a stroke?\n* Does sleep have an impact on the development of post-stroke epilepsy?\n\nParticipants will undergo:\n\n* Electroencephalography (EEG)\n* Magnetic resonance imaging (MRI)\n* Polysomnography (only patients)\n\nBlood tests will also be taken. The patient group will be compared to the healthy controls. Researchers will also look into medical records of stroke patients hospitalized at St. Olavs hospital and collect relevant information.",[61,62,63,64],"Post Stroke Epilepsy","Stroke","Epilepsy","Seizures",[66,67,68,69,70],"Cerebrovascular Disorders","Brain Diseases","Central Nervous System Diseases","Nervous System Disorders","Vascular Diseases","RECRUITING","2025-06-05",{"date":74,"type":37},"2025-06-10",{"date":76,"type":37},"2023-05-08",{"date":41,"type":22},{"name":79,"class":44},"Norwegian University of Science and Technology"]