[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"epilepsy-tonic-clonic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:epilepsy-tonic-clonic":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100590407","phase-4-a-clinical-study-on-the-efficacy-and-safety-of-zonisamide-as-a-first-add-on-treatment-in-epileptic-seizures-100590407",false,"NCT06967012","A Clinical Study on the Efficacy and Safety of Zonisamide as a First Add-On Treatment in Epileptic Seizures","Efficacy and Safety of Zonisamide as a First Add-On Treatment in Focal Epileptic Seizures or Secondary Generalized Tonic-Clonic Seizures: A Clinical Study","Inclusion Criteria:\n\n1. Consent to participate in the clinical trial, and the trial subject and\u002For legal guardian has signed the informed consent form.\n2. Age 1-14 years, no gender restrictions.\n3. Compliant with the diagnostic criteria for focal seizures and focal-to-bilateral tonic-clonic seizures as outlined by the International League Against Epilepsy (ILAE) in 2017.\n4. Stable on one antiepileptic drug for ≥4 weeks, and deemed to be appropriate for the addition of zonisamide therapy by the investigator.\n5. ≥ 2 episodes of generalized tonic-clonic seizures （secondary to focal epileptic seizures) per 28-day interval during the 8-week retrospective baseline period.\n\nExclusion Criteria:\n\n1. History of zonisamide treatment.\n2. History of allergy to sulfonamide drugs, zonisamide or any excipients.\n3. History of drug\u002Falcohol abuse.\n4. History of suicide attempt or suicidal ideation within the past 6 months.\n5. Current use of antidepressants, anxiolytics, or antipsychotics.\n6. Diagnosed with progressive diseases affecting the brain and its functions.\n7. Psychogenic non-epileptic seizures.\n8. Diagnosed with severe pulmonary\u002Fhematologic diseases, malignant tumors, immunodeficiency, or psychiatric illnesses.\n9. Have undergone epilepsy brain surgery or plan to undergo epilepsy surgery within the next 4 months.\n10. Deemed to be unsuitable for participation in the trial by the investigator.",true,"ALL","1 Year","14 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","This study primarily aims to assess the efficacy and safety of zonisamide when used as an adjunctive therapy for focal epilepsy. The main questions it aims to answer are:\n\n1. Does the frequency of epileptic seizures decrease after oral zonisamide， and does it improve cognitive function?\n2. Are there any treatment-emergent adverse events associated with oral administration of zonisamide?",[28,29],"Epilepsies, Partial","Epilepsy, Tonic-Clonic",[31,28,29],"Zonisamide","RECRUITING","2025-05-08",{"date":35,"type":36},"2025-05-13","ACTUAL",{"date":38,"type":36},"2024-08-01",{"date":40,"type":22},"2027-07-31",{"name":42,"class":43},"Affiliated Hospital of Nantong University","OTHER"]