[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"epilepsies-partial\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:epilepsies-partial":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,52,76,99],{"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":34,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100557160","phase-4-study-of-the-pharmacokinetics-safety-and-tolerability-of-zonisade-in-children-1-month-to-17-years-of-age-with-partial-onset-seizures-100557160",false,"NCT06534502","Study of the Pharmacokinetics, Safety, and Tolerability of ZONISADE in Children 1 Month to 17 Years of Age With Partial-onset Seizures","A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Zonisamide Oral Suspension (100 mg\u002F5 ml) to Determine a Dosing Regimen in Children 1 Month to 17 Years of Age With Partial-onset Seizures","Inclusion Criteria:\n\n* Pediatric participants (ages 1 month to 17 years of age, inclusive) will be considered eligible for the study based on the following criteria:\n\n  1. Voluntarily obtained informed consent from parent\u002Flegal guardian of the participant and assent from the participant, when appropriate.\n  2. Willing and able to follow protocol specific requirements.\n  3. Participant of 1 month to 17 years of age, inclusive (at time of consent).\n  4. Participant diagnosed with partial-onset (focal) seizures, with or without secondary generalization as per current International League Against Epilepsy (ILAE) classification of seizures. Participants with both focal-onset and generalized-onset seizures are eligible, but only focal-onset seizures count toward baseline seizure enrollment criteria. Tonic-clonic and tonic seizures with unknown onset are presumed to be focal-onset unless there are clear clinical and EEG data suggesting generalized-onset.\n  5. Participant with seizure occurrence more than once in the past three (3) months and more than two (2) times in the past six (6) months.\n\n     a. Participant who is 6 months of age and younger will have seizure profiling patterns assessed by the Investigator for appropriate consideration and inclusion in the study.\n  6. Participant on a stable regimen of anti-epilepsy drugs (AEDs) for at least 30 days before screening\n\n     a. Participant who is 6 months of age and younger will have regimen assessed for inclusion in the study at Investigator's discretion.\n  7. Participant with acceptable laboratory investigations:\n\n     1. Hemoglobin within normal range\n     2. Alanine aminotransferase (ALT) within normal range\n     3. Aspartate aminotransferase (AST) up to 1.5 x upper limit of normal (ULN)\n     4. Bilirubin within normal range\n     5. Creatinine clearance within normal range\n  8. If male participant is able to father children must be willing to use a highly effective method of contraception for at least one month after the last dose of investigational product if at risk of pregnancy with her\u002Fhis partner. If female participant has reached menarche, the participant is authorized to participate in this clinical study if additional criteria are met.\n\nAt screening:\n\n1. (i) Participant reports sexual abstinence for the prior 3 months or reports use of at least 1 of the acceptable methods of contraception, including an intrauterine device, barrier methods (e.g., male or female condom), hormonal contraceptives (e.g., hormonal patches, vaginal devices, oral pills), levonorgestrel intrauterine system (e.g., Mirena®), or regular medroxyprogesterone injections (e.g., Depo-Provera®); or (ii) Participant agrees to initiate sexual abstinence from the time of screening until at least one month after end of treatment with study drug; and\n2. Participant is advised to avoid conception from the time of screening until at least one month after last receipt of study drug and agrees not to attempt pregnancy from the time of screening until at least one month after end of treatment with study drug; and\n3. Participant is provided guidelines regarding continuation of abstinence, initiation of abstinence, or about allowed contraception; and\n4. Participant has a negative serum β-human chorionic gonadotropin (β-hCG) test just prior to study entry. Since serum tests may miss an early pregnancy, relevant menstrual history and sexual history, including methods of contraception, should be considered. Note: if the result of the serum β-hCG test cannot be obtained prior to dosing of investigational product, a participant may be enrolled on the basis of a negative urine pregnancy test, though a serum β-hCG test result must still be obtained.\n\nExclusion Criteria:\n\n* Pediatric participant will be excluded from the study based on the following criteria:\n\n  1. Known hypersensitivity to zonisamide or to any component of the investigational product or to sulfonamides.\n  2. Participant who is pregnant or nursing.\n  3. Participant with exclusively generalized-onset seizures.\n  4. Participant with predisposition to nephrolithiasis or prior history of kidney stone(s).\n  5. Participant who is underweight (weight-for-age \\\u003C2 standard deviation (SD) from the median of the World Health Organization (WHO) Child Growth Standards) or have a decreased appetite.\n  6. Participant currently on or scheduled to receive carbonic anhydrase inhibitors such as topiramate or acetazolamide.\n  7. Participant currently on or are scheduled to receive drugs known to have pharmacokinetic (PK) interaction.\n  8. Participant who has previously received zonisamide.\n  9. Participant with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).\n  10. Participant who has degenerative or metabolic disease of the brain.\n  11. Participant with history of psychiatric disorder (excluding stable attention deficit hyperactivity disorder (ADHD), mood disorder on adequate treatment).\n  12. Participant has any condition which, in the Investigator's opinion, would make it unsafe for the participant to participate in this study.\n  13. Participant who has participated in other clinical study 30 days prior to enrollment in this study or 4-5 half lives of investigational drug, whichever is longer.\n  14. Participant who uses alcohol or is currently on or scheduled to receive other central nervous system (CNS) depressants.\n  15. Participant has a positive COVID-19 polymerase chain reaction (PCR) test result; or has had exposure (within 2 weeks prior to screening) to someone who had a positive COVID-19 test result; or is suspected of having long COVID-19 by the Investigator or designee.\n  16. Participant who is missing more than 15% of daily diary entries during the screening period.","ALL","1 Month","17 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The purpose of this research is to determine the optimal dose, safety and tolerability of zonisamide oral suspension in children ages 1 month to 17 years of age who have partial-onset (focal) seizures. The study consists of four periods: a Screening Period (about 14 days), a Titration Period (8 weeks), a Maintenance Period (4 weeks), and a Follow-Up Period (1 week).",[27,28,29,30,31,32,33],"Seizures","Seizures, Focal","Seizure, Partial Onset","Seizure Disorder, Partial","Seizure, Partial","Epilepsies, Partial","Epilepsy",[35,36,37,38],"Partial-onset (focal) seizures","Pediatrics","ZONISADE","Zonisamide","NOT_YET_RECRUITING","2026-06-02",{"date":42,"type":43},"2026-06-04","ACTUAL",{"date":45,"type":21},"2026-09",{"date":47,"type":21},"2027-09",{"name":49,"class":50},"Azurity Pharmaceuticals","INDUSTRY",2,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100558408","high-resolution-multi-parametric-magnetic-resonance-imaging-for-focal-epilepsy-100558408","NCT06550726","High-resolution Multi-parametric Magnetic Resonance Imaging for Focal Epilepsy","Inclusion Criteria:\n\n* Consecutive patients with drug-resistant focal epilepsy fulfilling the following criteria -\n\n  1\\. Diagnosis of focal epilepsy with a probable site identified, as defined by concordant results from any TWO of the following:\n* Clinical seminology compatible with focal epilepsy.\n* Electroencephalography pointing towards a specific site for focal epilepsy.\n* Positive ictal brain scintigraphy with SPECT-CT correlation. AND 2. Previous MRI (at least one study with protocol tailored for epilepsy) which did not reveal accountable focal lesion.\n\nAND 3. Able to consent for MRI examination (if patient under age of 18, consent for MRI will be obtained from guardian). Patients will be provided information leaflets to read on, and written consent before taking part in this study and MRI examination.\n\nExclusion Criteria:\n\n* Patients who are contraindicated to magnetic resonance imaging (such as due to underlying MRI incompatible metallic implants)\n* Patients who cannot cooperate for MRI scanning.\n* Patients show are unable to provide informed consent.",{"count":59,"type":21},66,[61],"NA","Patients with focal epilepsy often have diagnostic difficulties as their culprit for seizures are difficult to be picked up using conventional imaging. The current study is to investigate the utility of advanced MRI sequences on detection of subtle lesions accountable for focal epilepsy.",[32],"RECRUITING","2026-03-30",{"date":67,"type":43},"2026-04-03",{"date":69,"type":43},"2024-09-01",{"date":71,"type":21},"2028-08-31",{"name":73,"class":74},"Chinese University of Hong Kong","OTHER",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100561494","phase-2-safety-of-cenobamate-in-japanese-subjects-with-partial-onset-seizures-100561494","NCT06590896","Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures","A Phase 2, Multicenter Open-Label Extension Study to Evaluate the Long-term Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures","Inclusion Criteria:\n\n* Subjects completed Study YKP3089C035 by SK Life Science.\n\nExclusion Criteria:\n\n* Subjects that have previously discontinued for any reason from the Core study (YKP3089C035).\n* Any significant changes to the medical history of the subject that in the opinion of the investigator, could affect the safety of the subject.",{"count":84,"type":21},100,[86],"PHASE2","To evaluate the long-term safety and tolerability of cenobamate in Japanese epilepsy patients with partial seizures",[32],"2025-06-01",{"date":91,"type":43},"2025-06-03",{"date":93,"type":43},"2022-11-04",{"date":95,"type":21},"2027-01-31",{"name":97,"class":50},"Ono Pharmaceutical Co., Ltd.",29,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":16,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":75},"100590407","phase-4-a-clinical-study-on-the-efficacy-and-safety-of-zonisamide-as-a-first-add-on-treatment-in-epileptic-seizures-100590407","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,"1 Year","14 Years",{"count":110,"type":21},30,[24],"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?",[32,114],"Epilepsy, Tonic-Clonic",[38,32,114],"2025-05-08",{"date":118,"type":43},"2025-05-13",{"date":120,"type":43},"2024-08-01",{"date":122,"type":21},"2027-07-31",{"name":124,"class":74},"Affiliated Hospital of Nantong University"]