[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-stroke-seizure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-stroke-seizure":60},{"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":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100506420","evaluation-of-tibial-nerve-selective-neurotomy-compared-to-botulinum-toxin-injections-for-spastic-foot-treatment-in-post-stroke-patients-according-to-a-goal-centered-approach-100506420","NCT05874154","Evaluation of Tibial Nerve Selective Neurotomy Compared to Botulinum Toxin Injections for Spastic Foot Treatment in Post-stroke Patients According to a Goal-centered Approach","FOOTNEUROTOX","Inclusion Criteria:\n\n* Adult patients (older than 18 years)\n* Man and woman\n* Hemiparesis secondary to stroke (delay from stroke \\> 1 year)\n* Foot with equinovarus with or without toe claw due to spasticity of at least the triceps surae and \u002For one of the following muscles: tibialis posterior, flexor digitorum and hallucis longus muscles.\n* Spasticity confirmed with no isolated tendon shortening diagnosed using tibialis nerve block under local anesthesia with at least a 5 degrees gain in passive or active ankle dorsal flexion.\n* Covered by National French insurance\n* Able to understand French and the purpose of the study\n* Informed consent signed by the patient or consent obtained from a relative or trusted person of the patient\n\nExclusion Criteria:\n\n* Known sensitivity to BoNT or botulinum toxin A excipients\n* Contraindication to surgery under general anesthesia\n* History of myasthenia\n* Pregnant woman (confirmed by urinary test) or breastfeeding\n* Patient under legal protection\n* Patients unable to follow the requirement of the study according to the investigator or supported by a family member","100 Years",{"count":55,"type":22},60,[57],"NA","In France, more than 110.000 patients are hospitalized for stroke per year. It is the leading cause of sudden disabilities in adults. Incidence of spastic foot is evaluated at 1 year post stroke from 18% to 56% of hemiplegic patients. Spasticity, defined as an increase in the velocity-dependent response to muscle stretch measured at rest, is part of the upper motor neuron syndrome and is characterized by an increase in tonic stretch reflex. It has been proposed that upper motor neuro syndrome may induce not only spasticity but also other types of muscles overactivity such as spastic dystonia, co-contraction and clonus. In hemiplegic patients, lower limb spasticity within the posterior part of the leg frequently results in equino-varus foot and toes claw. These abnormal postures in hemiplegics may affect activities of daily living such as shoes fitting, balance, ambulation-walking, comfort (pain) and may become irreducible (tendon shortening) if not treated.\n\nThe purpose of this study is to compare the interest of each treatment (BoNT-A versus STN) in order to specify both techniques indications and up-date current guidelines of lower-limb spasticity for hemiplegic patients.\n\nThis study aims to confirm a greater reduction of calf muscles spasticity after STN as compared to BoNT-A, as observed in the only published monocentric randomized controlled trial. Our study originality is to perform a multi-center RCT with a pre-established sample size. This study will also quantify progress towards personal goals using the goal attainment scaling (GAS) and will assess other components related to the consequences of carve muscle spasticity on balance, ambulation, self-care and quality of life.",[60,61],"Post Stroke Seizure","Spastic Foot",[63,64,65,66],"Tibial nerve selective neurotomy","botulinum toxin","spastic foot","post-stroke patient","RECRUITING","2025-07-09",{"date":70,"type":37},"2025-07-14",{"date":72,"type":37},"2024-01-02",{"date":74,"type":22},"2027-03-02",{"name":76,"class":44},"Hospices Civils de Lyon",4]