[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"seizures-focal\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:seizures-focal":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,85],{"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":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100553948","a-pilot-study-to-evaluate-the-efficacy-and-safety-of-navifus-system-neuromodulating-treatment-for-patients-with-drug-resistant-epilepsy-100553948","NCT06492720","A Pilot Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy","A Pilot, Open-label, Two-arm, Parallel-group Randomized Trial Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy","Inclusion Criteria:\n\n1. Male or female patients aged over than and equal to 18 years old.\n2. Patients with drug-resistant epilepsy (defined as at least 3 ASM failed) and 1-4 ASM at the time of study entry.\n3. Epileptogenic focus (or foci) is determined by comprehensive presurgical evaluation.\n4. At least 4 focal-onset seizures with objectively visible or significantly disabling manifestations in the 8-week baseline and at least one seizure per month in the baseline.\n5. Willing and able to sign written informed consent and be able to comply with the study protocol during the study period.\n\nExclusion Criteria:\n\n1. Patients with concurrent active psychiatric or mood disorders that have been assessed to interfere with participation in the study.\n2. Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants, or deep brain stimulation (DBS).\n3. The skull bone area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), wounds, or atrophy of the scalp.\n4. Image documented calcified lesion in the FUS exposure path.\n5. Abnormal coagulation profile:\n\n   1. Platelet (PLT) \\\u003C 100,000\u002FμL.\n   2. prothrombin time (PT) \\> 15 sec.\n   3. activated partial thromboplastin time (APTT) \\> 45 sec.\n   4. international normalized ratio (INR) \\> 1.5.\n   5. Patients requiring anticoagulant medications.\n6. Pregnant or breast-feeding women.\n7. Coexisting medical problems of sufficient severity to limit compliance with the study.\n8. Known sensitivity\u002Fallergy to Magnetic Resonance Imaging (MRI) contrast agents or any of its components; having metallic implants that are assessed as unsuitable for MRI examination.\n9. Use of any recreational drugs or history of drug addiction or known history of substance or alcohol abuse.\n10. Patients have received an investigational drug or an investigational device within 4 weeks prior to the study\n11. Any other condition that, in the investigator's judgment, might affect study endpoints or might increase the risk to the patients or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.\n12. Any ASM treatment change during the baseline (screening period).\n13. Vagus nerve stimulation (VNS) dosing changes within 2 months before baseline (screening period).\n14. Radiofrequency thermocoagulation (RFTC) within 2 months before baseline (screening period).\n15. Patient has an IQ \\\u003C 70, based on the Wechsler Abbreviated Scale of Intelligence (WASI-III or IV).\n16. Any other condition that, in the investigator's judgment, patient not applicable to participate this study.","18 Years","65 Years",{"count":62,"type":21},16,[64],"NA","This will be a prospective, pilot, open-label, two-arm, parallel-group, randomized study to evaluate the efficacy and safety of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant epilepsy (DRE).",[67,33,68,28],"Drug Resistant Epilepsy","Epilepsy, Temporal Lobe",[70,71,72,73],"NaviFUS System","Focused Ultrasound","Low-Intensity Focused Ultrasound","LIFU","RECRUITING","2026-04-06",{"date":77,"type":43},"2026-04-09",{"date":79,"type":43},"2024-09-01",{"date":81,"type":21},"2027-03-31",{"name":83,"class":50},"NaviFUS Corporation",1,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":59,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":5},"100545959","phase-1-a-safety-tolerability-and-preliminary-efficacy-of-low-intensity-focused-ultrasound-neuromodulation-in-patients-with-drug-resistant-epilepsy-100545959","NCT06388707","A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy","A Prospective, Open-label, Single-arm, Multi-center, Pilot Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Unilateral or Bilateral Temporal Lobe Epilepsy","Inclusion Criteria:\n\n1. Male or female patients ≥ 18 years of age at the time of enrollment.\n2. Patients with drug-resistant temporal lobe epilepsy (DR-TLE), defined as failure of adequate trials of two tolerated, appropriately chosen and used anti-epileptic drug schedules (whether as monotherapies or in combination).\n3. Focal-onset seizures with or without secondary generalization and no more than two known seizure onset zones (seizure foci), at least one which is in the mesial temporal lobe.\n4. At least 4 focal-onset seizures with objectively visible or significantly disabling manifestations in the 8-week baseline and at least one seizure per month in the baseline.\n5. MRI and EEG within the past 3 years. At least one prior EEG should demonstrate interictal or ictal focal epileptiform findings.\n6. Patients with the central of FUS exposure region are located at least 30 mm distance beneath the skull bone.\n7. Patients must be on a stable regimen of anti-epileptic drugs (AEDs) for at least 30 days at the time of enrollment, except for rescue benzodiazepines or occasional extra doses of ongoing medicines, as required.\n8. Females of childbearing potential must have a negative pregnancy test prior to the first treatment. Females of childbearing potential and male patients with a partner of childbearing potential must agree to follow acceptable method of contraception (as outlined below) from prior to the first study treatment to 3 months after the last study treatment. Standard acceptable methods include use of highly effective method of contraception, including: hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, spermicide, vasectomy, intrauterine device, and abstinence from sex.\n9. Patients are able and willing to have their hair shaved in the region where the coupling membrane will touch (or if they prefer, whole head).\n10. Patients are able to complete all clinical trial-related questionnaires in English, including with the use of a suitable interpreter.\n11. Patients or their legal representatives are able to provide written informed consent for participation in the trial and comply with study requirements in the opinion of the Investigator during the study period.\n\nExclusion Criteria:\n\n1. Patients who have primary generalized epilepsy, mixed focal and generalized epilepsy, or any history of non-epileptic seizures.\n2. Patients who have experienced tonic-clonic status epilepticus in the 12 months before the time of enrollment in the study. Subjects with focal status epilepticus may be considered at the discretion of the Investigator.\n3. The only feasible sonication pathway to the seizure onset zones involves either:\n\n   1. Skull area is covered by previous surgical site(s), scars, scalp disorders (e.g., eczema, psoriasis), or scalp atrophy.\n   2. Clips or other metallic implanted objects in the skull or brain, except shunts.\n   3. A prior craniotomy site.\n4. Patients with a potentially acute or progressive neurologic disorder (e.g., brain tumor, multiple sclerosis, dementia, or intracranial vascular lesion).\n5. Implanted electronic device, for example, implanted cardioverter-defibrillator (ICD), cardiac pacemaker, permanent medication pumps, cochlear implants, responsive neurostimulator, deep brain stimulation (DBS), or other electronic devices implanted in the brain. If a patient has a working Vagus Nerve Stimulator (VNS) in place, the settings should remain stable throughout the trial and the device will be turned off prior to each sonication treatment and then turned back on afterward.\n6. Patients with severe depression, active suicidal ideation or behavior (as per the C-SSRS), active psychosis (excluding time-limited postictal psychosis), or psychiatric hospitalization in the year before time of enrollment.\n7. Patient has an IQ \\\u003C 70, based on the Wechsler Abbreviated Scale of Intelligence (WASI-II or other Wechsler IQ measure).\n8. Coexisting medical problems of sufficient severity to limit compliance with or interpretation of the study.\n9. Patients have received an investigational drug or an investigational device within 4 weeks prior to the first treatment.\n10. Radiofrequency thermocoagulation (RFTC) within 2 months before time of enrollment.\n11. Known history of substance or alcohol abuse within the past year, not counting marijuana.\n12. Pregnant or breast-feeding women.\n13. Any other condition that, in the Investigator's judgment, might affect study endpoints or might increase the risk to the patients or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.",{"count":93,"type":21},8,[95,96],"PHASE1","PHASE2","This will be a prospective, open-label, single-arm, multi-center, pilot study to evaluate the safety, tolerability, and preliminary efficacy of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant unilateral or bilateral temporal lobe epilepsy (DR-TLE).",[67,33,28,99,100],"Seizure","Seizure Disorder",[70,71,72,73],{"date":77,"type":43},{"date":104,"type":43},"2024-09-13",{"date":106,"type":21},"2027-05-31",{"name":83,"class":50}]