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
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Kawasaki Medical School Hospital
- 入组人数
- 10
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
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
结局指标
主要结局
未指定
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