JPRN-jRCTs011180016已完成未知
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
shiraishi hideaki0 个研究点目标入组 2 人开始时间: 2019年3月19日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 2
研究概览
简要总结
Sirolimus was administered to two children with focal cortical dysplasia type II, and their safety was examined. During the study period, no adverse events occurred and the safety of sirolimus administration was confirmed. There were no significant changes in seizure frequency and symptoms.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 2age old 至 < 65age old（—）
- 性别
- All
入选标准
- •1) 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.
排除标准
- •1) 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.
研究者
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