[{"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:":44},{"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":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"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":21,"type":22},200,"ESTIMATED","INTERVENTIONAL",[25],"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).",[28],"Tuberous Sclerosis Complex",[30],"tuberous sclerosis complex, epilepsy, rapamycin, drug resistant epilepsy","RECRUITING","2023-08-07",{"date":34,"type":35},"2023-08-08","ACTUAL",{"date":37,"type":35},"2023-01-23",{"date":39,"type":22},"2027-06",{"name":41,"class":42},"Katarzyna Kotulska","OTHER",2,""]