[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Katarzyna Kotulska\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"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":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"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).",[27],"Tuberous Sclerosis Complex",[29],"tuberous sclerosis complex, epilepsy, rapamycin, drug resistant epilepsy","RECRUITING","2023-08-07",{"date":33,"type":34},"2023-08-08","ACTUAL",{"date":36,"type":34},"2023-01-23",{"date":38,"type":21},"2027-06",{"name":40,"class":41},"Katarzyna Kotulska","OTHER",2,""]