Clinical research on efficacy and safety of sirolius against epileptic seitures of focal cortical s\dysplasia type II (Research of sirolimus administration for FCD II type)

未提供0 个研究点目标入组 2 人开始时间: 2018年2月28日最近更新: 2021年3月30日

适应症

试验速览

暂无简介。

•Persons who are diagnosed pathologically by having localized cortical dysplasia type2 2) Patient who is treated for at least 1 year with two or more antiepileptic drugs after diagnosis with epilepsy. 3) Patients under treatment with 1 to 4 antiepileptic drugs. 4) Patients whose dose and usage of antiepileptic drug administration are constant from 28 days prior to the start of the preview period prior to obtaining consent. 5) Patients with two or more epileptic seizures in 28 days during the previewing period.

•Patients taking oral administration of other test drugs (drugs used in other clinical studies / clinical trials) before the start of the study, just before the observation period. 2) Currently, patients taking sirolimus or everolimus internally or who have ever taken internal medicine. 3) Felbamate, Vigabatrin was taking within 6 months. 4) Patients who can not accurately record the number and time of epileptic seizures by the patient or substitute. 5) Patients who are suspected of progressive lesions with Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) performed so far. 6) Patients who underwent cerebral surgery for epilepsy (cortical resection, functional hemisphere dissection, cerebral ablation, vagus nerve stimulation) within 180 days prior to obtaining consent. 7) Patients during ketogenic diet therapy. 8) Patients who have suicide attempts in the past. 9) Patients with a history or complication of substance abuse (including alcohol abuse). 10) Patients who are pregnant women who can not perform contraception during the study period (including partners), pregnant or lactating.

Safety in clinical research enforcement and presence or absence of occurrence of adverse events

发起方

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