[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593748":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":39,"centralContacts":43,"locations":49,"responsibleParty":155,"collaborators":35,"id":157,"slug":158,"hasResults":159,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":159,"sex":165,"minAge":166,"maxAge":167,"enrollmentInfo":168,"targetDuration":35,"studyType":171,"phases":172,"briefSummary":174,"conditions":175,"keywords":177,"overallStatus":52,"whyStopped":35,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":190},{"fullName":5,"class":6},"Praxis Precision Medicines","INDUSTRY",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A: Double-Blind Treatment Period","EXPERIMENTAL","Eligible participants will be randomly assigned in a double-blind manner and a 1:1 ratio to receive 1.0mg-1.5mg\u002Fkg relutrigine or placebo once daily orally or gastronomy\u002Fjejunostomy for 16 weeks",[13,14],"Drug: 1.0mg\u002Fkg\u002Fday PRAX-562","Drug: 1.5mg\u002Fkg\u002Fday PRAX-562",{"label":16,"type":17,"description":11,"interventionNames":18},"Part A: Double-Blind Treatment Period (Placebo)","PLACEBO_COMPARATOR",[19],"Drug: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Part B: Open-Label Extension Treatment Period","Participants from Part A will have the option to rollover to Part B to receive 1.0mg-1.5mg\u002Fkg of relutrigine once daily orally or gastronomy\u002Fjejunostomy for 32 weeks",[13,14],[25,32,36],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","1.0mg\u002Fkg\u002Fday PRAX-562","Once daily orally or gastronomy\u002Fjejunostomy",[9,21],[31],"relutrigine",{"type":26,"name":33,"description":28,"armGroupLabels":34,"otherNames":35},"1.5mg\u002Fkg\u002Fday PRAX-562",[9,21],null,{"type":26,"name":37,"description":28,"armGroupLabels":38,"otherNames":35},"Placebo",[16],[40],{"name":41,"affiliation":5,"role":42},"Medical Director","STUDY_DIRECTOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":35,"email":48},"Head of Pharmacovigilance","CONTACT","617-300-8460","clinicaltrials@praxismedicines.com",[50,64,73,82,91,100,109,120,131,139,147],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":35},"Praxis Research Site","RECRUITING","La Jolla","California","92037","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-117.2742,32.84727,{"lat":62,"lon":61},{"facility":51,"status":52,"city":65,"state":66,"zip":67,"country":56,"countryCode":57,"cosmosGeoPoint":68,"geoPoint":72,"contacts":35},"Gulf Breeze","Florida","32561",{"type":59,"coordinates":69},[70,71],-87.16386,30.35714,{"lat":71,"lon":70},{"facility":51,"status":52,"city":74,"state":75,"zip":76,"country":56,"countryCode":57,"cosmosGeoPoint":77,"geoPoint":81,"contacts":35},"Chevy Chase","Maryland","20815",{"type":59,"coordinates":78},[79,80],-77.07115,39.00287,{"lat":80,"lon":79},{"facility":51,"status":52,"city":83,"state":84,"zip":85,"country":56,"countryCode":57,"cosmosGeoPoint":86,"geoPoint":90,"contacts":35},"Roseville","Minnesota","55113",{"type":59,"coordinates":87},[88,89],-93.15661,45.00608,{"lat":89,"lon":88},{"facility":51,"status":52,"city":92,"state":93,"zip":94,"country":56,"countryCode":57,"cosmosGeoPoint":95,"geoPoint":99,"contacts":35},"Hackensack","New Jersey","07601",{"type":59,"coordinates":96},[97,98],-74.04347,40.88593,{"lat":98,"lon":97},{"facility":51,"status":52,"city":101,"state":102,"zip":103,"country":56,"countryCode":57,"cosmosGeoPoint":104,"geoPoint":108,"contacts":35},"Philadelphia","Pennsylvania","19104",{"type":59,"coordinates":105},[106,107],-75.16362,39.95238,{"lat":107,"lon":106},{"facility":51,"status":52,"city":110,"state":111,"zip":112,"country":113,"countryCode":114,"cosmosGeoPoint":115,"geoPoint":119,"contacts":35},"Heidelberg","Victoria","3084","Australia","AU",{"type":59,"coordinates":116},[117,118],145.06667,-37.75,{"lat":118,"lon":117},{"facility":51,"status":52,"city":121,"state":122,"zip":123,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":130,"contacts":35},"Rio Grande","Do Sul","90610","Brazil","BR",{"type":59,"coordinates":127},[128,129],-52.09861,-32.035,{"lat":129,"lon":128},{"facility":51,"status":52,"city":132,"state":35,"zip":133,"country":124,"countryCode":125,"cosmosGeoPoint":134,"geoPoint":138,"contacts":35},"Paraná","80250",{"type":59,"coordinates":135},[136,137],-38.31306,-6.48639,{"lat":137,"lon":136},{"facility":51,"status":52,"city":140,"state":35,"zip":141,"country":124,"countryCode":125,"cosmosGeoPoint":142,"geoPoint":146,"contacts":35},"Rio de Janeiro","20231",{"type":59,"coordinates":143},[144,145],-43.18223,-22.90642,{"lat":145,"lon":144},{"facility":51,"status":52,"city":148,"state":35,"zip":149,"country":124,"countryCode":125,"cosmosGeoPoint":150,"geoPoint":154,"contacts":35},"São Paulo","15090",{"type":59,"coordinates":151},[152,153],-46.63611,-23.5475,{"lat":153,"lon":152},{"type":156,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","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":169,"type":170},160,"ESTIMATED","INTERVENTIONAL",[173],"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",[176],"Developmental and Epileptic Encephalopathy 1",[178,179,180],"DEE","Developmental and Epileptic Encephalopathy","epilepsy","2026-05-08",{"date":183,"type":184},"2026-05-11","ACTUAL",{"date":186,"type":184},"2025-07-09",{"date":188,"type":170},"2027-11",{"name":5,"class":6},11]