JPRN-UMIN000015538已完成3 期
A multicentre, long-term administration study of KN01 in patients with mitochondrial encephalomyopathy(MELAS) - MELAS-taurine long-term study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
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
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •(1) Patients can not be conducted by head MRI scan because of pacemaker implantation, etc. (2) Patients with severe coma or status epileptics (3) Patients incapable of communication due to dementia, bedridden, etc., (4) Patients with merger sepsis (5) Patients with severe impairment in cardiac, liver, or renal function (6) Patients in need of systemic administration of steroids for a long period of time (2 weeks or more) (7) Patients with pyruvate in 12 weeks before obtaining informed consent (8) Patients who are pregnant or lactating, or may be pregnant (9) Patients with history of hypersensitivity to the component of study drug (10)Ppatients with history of drug allergy (11) Patients who participated in clinical trials within 12 weeks before obtaining informed consent (12) Other, patients whom physician or investigator has determined disqualified as participants
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