JPRN-UMIN000033504已完成2 期
An uncontrolled open-label study on the efficacy and safety of sirolimus for epileptic seizures associated with focal cortical dysplasia type-II - An investigator-initiated clinical trial on the efficacy and safety of sirolimus for epileptic seizures associated with FCD type-II
Hokkaido University Hospital Nishi-Niigata Chuo National Hospital National Center Hospital, NCNP Shizuoka Institute of Epilepsy and Neurological Disorders Okayama University Hospital0 个研究点目标入组 16 人开始时间: 2018年7月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 6years-old 至 65years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Those participated in other trials within 12 weeks before the time of consent. 2. Having used sirolimus or everolimus within 52 weeks before enrollment. 3. Who cannot accurately record the number and time of epileptic seizures by themselves/representatives. 4. Suspected of progressive lesions in CT or MRI. 5. Having underwent cerebral surgery for epilepsy within 28 weeks prior to enrollment. 6. Taking Felbamate or Vigabatrine or having taken it within 28 weeks before enrollment. 7. Under ketogenic diet therapy. 8. Having suicide attempts in the past. 9. With a history or complications of substance abuse including alcohol abuse. 10. Those possibly pregnant and cannot perform contraception during the study period (including partners), pregnant or lactating. 11. Falling under any of the following in clinical examination during baseline observation period: - At least 2.5 times the reference value of AST or ALT - WBC count of less than 3,000/micro L, Ht of less than 30%, platelets of less than 80,000/micro L, or neutrophil counts of less than 1,000/ micro L - Ccr of less than 50 ml/min - HBs antigen-positive, HBs antibody-positive except after vaccination with hepatitis B vaccine, or HBc antibody-positive. Or active hepatitis C excluding inactive cases with normal liver function. - In poor control of dyslipidemia with serum triglycerides of 500 mg/dL or more, or LDL cholesterol of 190 mg/dL or more despite being treated for dyslipidaemia. - With renal dysfunction. (eGFR of less than 30 ml/min/1.73 m2) 12. With complications of arrhythmia requiring treatment. 13. With complications of heart/renal failure that may affect hemodynamics. 14. With immunodeficiency complications. 15. Having underwent surgery (surgery requiring invasion into a body cavity or surgery requiring suture of three or more needles including biopsy) within 12 weeks before enrollment. 16. Judged inappropriate for participating in this study by the principal investigator/sub-investigators.
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