JPRN-jRCT1091220093尚未招募2 期
Placebo controlled double blind randomized Phase II Clinical Trial of sodium pyruvate on lactic acidosis associated with mitochondrial disorders - Lactic acidosis associated with mitochondrial disorders, intervention by sodium pyruvate
Yasutoshi KogaDepartment of Pediatrics and Child Health, Kurume University School of Medicine0 个研究点目标入组 12 人开始时间: 2012年7月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
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
- >= 6age old 至 < 70age old（—）
- 性别
- All
入选标准
- •mitochondrial disease who fulfilled the following criteria
- •1) patient whoes age is over than 6 years-old
- •2) patient who are fulfilled the diagnostic criteria of MELAS/MELA
- •3) patientwho has an A3243G mutation.
- •4) no past history of sodium pyruvate administration for the therapeutic purpose
- •5) patient whose score of section 1+2 by JMDRS is more than 10, and one of the specific score is more than 2.
- •6) patient who have a written informed conscent or ascent by his/her own opinion.
排除标准
- •1) patient who has bed ridden status
- •2) patient who has dementic status and cannot be evaluated the JMDRS/NMDAS by medical doctor
- •3) patient who has uncontrolled status epileptics
- •4) patient who has septic status
- •5) patient who has renal failre, and less than 60mL/min/1.73m by eGFR
- •6) patient who has hypertrophic cardiomyopathy or cardiac failre
- •7) patient who has allergic state against sodium pyruvate
- •8) patient who enrolled to the other clinical trial within 6 months
- •9) patient who has pregnant
- •10) patient who is not recommended to the entry by medical doctor
研究者
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