Multicenter, randomized, double-blind, placebo controlled study to assess the efficacy and safety of Rapamycin in drug Resistant Epilepsy associated with TSC (RaRE-TS) - RaRE-TS

The Children's Memorial Health Institute0 个研究点目标入组 200 人开始时间: 2022年12月8日最近更新: 2024年1月8日

研究概览

暂无简介。

•-male or female aged from 3 months up to 50 years at the day of randomization
•-patients/parents/caregivers are willing to and able to give informed consent form for the participation in the study
•-patients/parents/caregivers are willing to and able to comply with all study requirements
•-definite diagnosis of TSC according to the Consensus criteria (Northrup, 2013)
•-drug-resistant epilepsy associated with TSC with at least 8 seizures during 4 weeks
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 160
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-history of treatment with mTOR inhibitor in the three months prior to screening,
•-history of pseudo-epileptic seizures,
•-history of progressive CNS disease other than TSC
•-recent surgery within 2 weeks prior to the screening
•-severe infection within 2 weeks prior to the screening
•-use of the cannabis derivatives
•-contraindications for MRI or general anesthesia
•-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
•-pregnancy

发起方

The Children's Memorial Health Institute