[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590407":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":44,"collaborators":20,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":20,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":20,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":29,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Affiliated Hospital of Nantong University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Monotherapy and add-on therapy","EXPERIMENTAL","Zonisamide tablets are administered orally with the following dosage schedule: Weeks 1-2: 2 mg\u002Fkg\u002Fday, Weeks 3-4: 4 mg\u002Fkg\u002Fday, Weeks 5-6: 6 mg\u002Fkg\u002Fday. After the initial six weeks, the dosage is adjusted based on the patient's condition, with weekly increments of 1 mg\u002Fkg\u002Fday. The maintenance dose ranges from 4 to 6 mg\u002Fkg\u002Fday, administered in 1-2 divided doses daily. Participants weighing ≥50 kg receive adult-equivalent dosing.",[13],"Drug: Oral Zonisamide Therapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Oral Zonisamide Therapy","Zonisamide tablets are administered orally with the following dosage schedule: Weeks 1-2: 2 mg\u002Fkg\u002Fday, Weeks 3-4: 4 mg\u002Fkg\u002Fday, Weeks 5-6: 6 mg\u002Fkg\u002Fday. After the initial six weeks, the dosage is adjusted based on the patient's condition, with weekly increments of 1 mg\u002Fkg\u002Fday. The maintenance dose ranges from 4 to 6 mg\u002Fkg\u002Fday, administered in 1-2 divided doses daily. For children weighing ≥50 kg, the adult dosage should be used.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"youjia Y Wu, Doctorate","CONTACT","13962969655","francis_nt@163.com",[28],{"facility":5,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"RECRUITING","Nantong","Jiangsu","226000","China","CN",{"type":36,"coordinates":37},"Point",[38,39],120.87472,32.03028,{"lat":39,"lon":38},[42],{"name":23,"role":24,"phone":43,"phoneExt":20,"email":26},"+8613962969655",{"type":45,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","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":58,"type":59},30,"ESTIMATED","INTERVENTIONAL",[62],"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?",[65,66],"Epilepsies, Partial","Epilepsy, Tonic-Clonic",[68,65,66],"Zonisamide","2025-05-08",{"date":71,"type":72},"2025-05-13","ACTUAL",{"date":74,"type":72},"2024-08-01",{"date":76,"type":59},"2027-07-31",{"name":5,"class":6},1]