[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100480337":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":73,"collaborators":25,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":25,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":61,"whyStopped":25,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Children's Memorial Health Institute, Poland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Rapamycin arm","EXPERIMENTAL","Each patient randomized to the rapamycin arm will receive rapamycin in liquid. The rapamycin will be administered in individually calculated doses depending on the body surface of participants",[13],"Other: Rapamycin",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo arm","PLACEBO_COMPARATOR","The patients assigned to the placebo arm will receive placebo in liquid, analogically to the rapamycin group.",[19],"Other: Placebo",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Rapamycin","Rapamycin in liquid administered orally",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo","Placebo in liquid administered orally",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Katarzyna Kotulska-Jozwiak","CONTACT","+48 22 8157404","k.kotulska@ipczd.pl",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Monika Szkop","+48 22 815 74 88","m.szkop@ipczd.pl",[41,59],{"facility":42,"status":43,"city":44,"state":25,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Medical University of Lodz","NOT_YET_RECRUITING","Lodz","90-419","Poland","PL",{"type":49,"coordinates":50},"Point",[51,52],19.47395,51.77058,{"lat":52,"lon":51},[55],{"name":56,"role":33,"phone":57,"phoneExt":25,"email":58},"Wojciech Mlynarski","+48 42 617-77-91","wojciech.mlynarski@umed.lodz.pl",{"facility":60,"status":61,"city":62,"state":25,"zip":63,"country":46,"countryCode":47,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Children's Memorial Health Institute, Neurology and Epileptology","RECRUITING","Warsaw","04-730",{"type":49,"coordinates":65},[66,67],21.01178,52.22977,{"lat":67,"lon":66},[70,71],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},{"name":37,"role":33,"phone":72,"phoneExt":25,"email":39},"+48 22 815 74 04",{"type":74,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Katarzyna Kotulska","Head of the Department of Neurology and Epileptology at The Children's Memorial Health Institute","100480337","phase-3-placebo-controlled-study-to-assess-the-efficacy-and-safety-of-rapamycin-in-drug-resistant-epilepsy-associated-with-tuberous-sclerosis-complex-100480337",false,"NCT05534672","Placebo Controlled Study to Assess the Efficacy and Safety of Rapamycin in Drug Resistant Epilepsy Associated With Tuberous Sclerosis Complex","Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of Rapamycin in Drug Resistant Epilepsy Associated With TSC","RaRE-TS","Inclusion Criteria:\n\n* male or female aged from 3 months up to 50 years at the day of randomization\n* patients\u002Fparents\u002Fcaregivers are willing to and able to give informed consent form for the participation in the study\n* patients\u002Fparents\u002Fcaregivers are willing to and able to comply with all study requirements\n* definite diagnosis of TSC according to the Consensus criteria (Northrup, 2013)\n* drug-resistant epilepsy associated with TSC with at least 8 seizures during 4 weeks\n\nExclusion Criteria:\n\n* history of treatment with mTOR inhibitor in the three months prior to screening,\n* history of pseudo-epileptic seizures,\n* history of progressive CNS disease other than TSC\n* recent surgery within 2 weeks prior to the screening\n* severe infection within 2 weeks prior to the screening\n* use of the cannabis derivatives\n* contraindications for MRI or general anesthesia\n* occurrence of the serious comorbidities which, in the opinion of the investigator, may either put a patient at significant risk associated with the participation in the study or may influence the results of the study the investigator\n* pregnancy","ALL","3 Months","50 Years",{"count":89,"type":90},200,"ESTIMATED","INTERVENTIONAL",[93],"PHASE3","The purpose of the RaRE-TS study is to determine safety, tolerability and efficacy of rapamycin versus placebo in a drug resistant epilepsy associated with tuberous sclerosis complex (TSC).",[96],"Tuberous Sclerosis Complex",[98],"tuberous sclerosis complex, epilepsy, rapamycin, drug resistant epilepsy","2023-08-07",{"date":101,"type":102},"2023-08-08","ACTUAL",{"date":104,"type":102},"2023-01-23",{"date":106,"type":90},"2027-06",{"name":75,"class":6},2]