[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Epygenix\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100444345","phase-3-an-efficacy-and-safety-study-of-clemizole-hcl-in-patients-with-lennox-gastaut-syndrome-100444345",false,"NCT05066217","An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome","Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Clemizole HCl as Adjunctive Therapy in Patients With Lennox-Gastaut Syndrome","Key Inclusion Criteria:\n\n1. Males or females, ages ≥2 to ≤55 years, at the time of Screening.\n2. Participant\u002Fparent\u002Flegal authorized representative (LAR) willing and able to give written informed consent\u002Fassent.\n3. Diagnosis of LGS, including:\n\n   * Evidence of at least one type of countable major motor seizure.\n   * History of electroencephalogram (EEG) consistent with LGS (abnormal background activity, and one of the following: 1) slow spike-wave discharges \\[\\\u003C2.5 Hz\\], or 2) paroxysmal fast activity during sleep).\n   * Abnormal cognitive development.\n   * Onset of seizures at 11 years of age or younger.\n\nKey Exclusion Criteria:\n\n1. Known sensitivity, allergy, or previous exposure to clemizole HCl.\n2. Known history of long QT syndrome or any significant history of a serious abnormality of the electrocardiogram (ECG) (e.g., recent myocardial infarction, clinically significant arrhythmia).\n3. Family history of sudden cardiac death, unexplained death, or death from a primary dysrhythmia potentially associated with QT prolongation in any family member.\n4. Seizures secondary to illicit drug or alcohol use, infection, neoplasm, demyelinating disease, degenerative neurological disease, or progressive central nervous system disease, metabolic illness, recent anoxic episode within the last 6 months requiring resuscitation, or progressive degenerative disease or any other condition, which in the opinion of the investigator, could affect seizure control.\n5. Epilepsy surgery planned during the study or epilepsy surgery within 6 months prior to Screening.\n6. Concomitant use of fenfluramine.\n7. Prior or concomitant use of lorcaserin.","ALL","2 Years","55 Years",{"count":20,"type":21},260,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole HCL (EPX-100) as adjunctive therapy in children and adult participants with Lennox-Gastaut syndrome (LGS).",[27],"Lennox Gastaut Syndrome",[27,29,30,31,32],"Lennox-Gastaut Syndrome","LGS","Clemizole HCl","Seizure","RECRUITING","2026-07-01",{"date":36,"type":37},"2026-07-02","ACTUAL",{"date":39,"type":37},"2025-04-09",{"date":41,"type":21},"2029-11-01",{"name":43,"class":44},"Epygenix","INDUSTRY",26,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100398026","phase-3-a-study-of-epx-100-clemizole-hydrochloride-in-participants-with-dravet-syndrome-100398026","NCT04462770","A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome","A 20-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of EPX-100 (Clemizole Hydrochloride) as Adjunctive Therapy in Children and Adult Participants With Dravet Syndrome (ARGUS Trial)","ARGUS","Key Inclusion Criteria:\n\n1. Male and female participants 2 years and older at time of consent.\n2. Participant or parent\u002Flegally authorized representative (LAR) willing and able to provide written informed consent and assent (if applicable) prior to initiation of any study related procedures.\n3. Clinical diagnosis of DS. Participants must have seizures which are not completely controlled by AEDs with the following criteria:\n\n   * Onset of seizures prior to 18 months of age,\n   * Normal development at onset,\n   * History of at least one type of countable motor seizure (CMS),\n   * Brain MRI without cortical malformation (not including mild atrophy associated with the natural progression of DS),\n   * Genetic mutation of the SCN1A gene must be documented.\n\nKey Exclusion Criteria:\n\n1. Known sensitivity, allergy, or previous exposure to clemizole HCl.\n2. Exposure to any investigational drug or device \\\u003C90 days prior to screening or plans to participate in another drug or device trial at any time during the study.\n3. Seizures secondary to illicit drug (this includes concomitant use of tetrahydrocannabinol \\[THC\\] and nonprescription cannabidiol preparations) or alcohol use, infection, neoplasm, demyelinating disease, degenerative neurological disease, or central nervous system disease deemed progressive, metabolic illness, or progressive degenerative disease.\n4. Concurrent use of lorcaserin. Note: Prior use of lorcaserin is permitted if at least 30 days have passed since the last dose.\n5. Concurrent use of fenfluramine.\n6. Epilepsy surgery planned during the study or epilepsy surgery within 6 months prior to Screening.",{"count":55,"type":21},150,[24],"This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole hydrochloride (EPX-100) as adjunctive therapy in children and adult participants with Dravet syndrome (DS).",[59],"Dravet Syndrome",[61,62,63,64],"Clemizole hydrochloride","Convulsive seizure","Pediatric epilepsy","Dravet syndrome","2026-06-26",{"date":67,"type":37},"2026-06-30",{"date":69,"type":37},"2020-09-15",{"date":71,"type":21},"2029-05",{"name":43,"class":44},60,""]