[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"developmental-and-epileptic-encephalopathy-1\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:developmental-and-epileptic-encephalopathy-1":28},{"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":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100593748","phase-3-a-clinical-trial-for-participants-with-dee-to-assess-efficacy-safety-tolerability-and-pk-of-relutrigine-100593748",false,"NCT07010471","A Clinical Trial for Participants With DEE to Assess Efficacy, Safety, Tolerability, and PK of Relutrigine","A Phase 3, Randomized, Multi-Center, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Relutrigine in Participants With DEE Followed by an Open-Label Extension","EMERALD","Inclusion Criteria:\n\n* Has a documented diagnosis of a developmental and epileptic encephalopathy.\n* Onset of seizures \\\u003C12 years old.\n* Has a weight \\>7 kg at the time of signing consent\u002Fassent.\n\nExclusion Criteria:\n\n* Has a history of left bundle branch block, arrhythmias, Brugada syndrome, congenital heart disease, familial short QT syndrome, or family history of sudden death or ventricular arrhythmias, including idiopathic ventricular fibrillation.\n* Had 2 or more episodes of convulsive status epilepticus requiring hospitalization and intubation in the 6 months prior to Screening.\n* Has an abnormal ECG reading, including a QT interval corrected for heart rate using Bazett's method (QTcB) \\\u003C350 and \\>450 ms (males), or \\\u003C360 and \\>460 ms (females) at Screening and\u002For on Day 1.\n* Any nerve stimulation must have been placed at least 3 months prior to Screening with at least 1 month of stable settings prior to Screening.\n* Has received any other experimental or investigational drug, device, or other therapy within 30 days or 5 half-lives (whichever is longer) prior to Screening, including any prior use of gene therapy.\n* Is currently pregnant or breastfeeding or is planning to become pregnant during the clinical trial or within 5 half-lives of the last study drug dose.","ALL","2 Years","65 Years",{"count":21,"type":22},160,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","A Phase 3, Randomized, Multi-Center, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Relutrigine in Participants with Developmental and Epileptic Encephalopathies Followed by an Open-Label Extension",[28],"Developmental and Epileptic Encephalopathy 1",[30,31,32],"DEE","Developmental and Epileptic Encephalopathy","epilepsy","RECRUITING","2026-05-08",{"date":36,"type":37},"2026-05-11","ACTUAL",{"date":39,"type":37},"2025-07-09",{"date":41,"type":22},"2027-11",{"name":43,"class":44},"Praxis Precision Medicines","INDUSTRY",11]