NCT01078714已完成3 期
Study of the Efficiency of a Treatment by Bumetanide in a Population of Autistic Children
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Child Autism Rating Scale score
研究概览
简要总结
The purpose of this study is to determine if a treatment by bumetanide presents an efficiency at the level of the neuronal maturation in the autism
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children from 3 to 10 years old, answering the diagnosis of typical autism according to the diagnostic criteria of autism of the classification of the WHO ( CIM-10) and the parents of which gave a free, enlightened and written consent.
排除标准
- •Patients epileptic autistics treated by anticomitiaux or having hurts of the central nervous system
- •Patients autistics receiving a psychotropic treatment
- •Patients presenting disorders electrolytes
- •Patients presenting a hypersensibility known about sulpha drugs
- •Presenting patients against indications relative to the treatment by bumetanide
- •Patients already treated by diuretics
- •Patients presenting a hepatic or renal incapacity
- •Patients presenting an elongation of the QT to the electrocardiogram.
- •Patients autistics of CARS sore is lower than 30.
研究组 & 干预措施
Bumetanide
Experimental
干预措施: bumetanide (Drug)
Control
Placebo Comparator
干预措施: bumetanide (Drug)
结局指标
主要结局
Child Autism Rating Scale score
时间窗: day 0 to day 90
次要结局
- Clinical global impressions score(day 0 to day 90)
- Repetitive end restricted behavior score(day 0 to day 90)
- GRAM score(day 0 to day 90)
研究者
研究点 (3)
Loading locations...
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