EUCTR2016-000106-11-FR进行中（未招募）1 期
EVALUATION OF THE EFFICIENCY OF TREATMENT BY BUMETANIDE ON AUTISTIC CHILDREN WITH A KNOWN ETIOLOGY: MULTICENTER AND DOUBLE-BLIND STUDY WITH RANDOMIZED PARALLEL GROUP, AGAINST PLACEBO. - BUMAUTEP
imoges Hospital0 个研究点目标入组 88 人开始时间: 2016年10月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 88
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Children and teenager from age 5 to age 17, with a diagnosis of typical autism or Asperger syndrome according to the criteria of diagnosis of the WHO’s classification (CIM-10),
- •- With a known etiology,
- •- Of whom the parents have given their free, informed and written consent,
- •- Affiliated or beneficiary of the French social security.
- •Patient taking melatonin and stabilized are eligible to the trial,
- •Patient with a stabilized epilepsy by treatment (no comitial crisis for the 6 months before entering the trial) are eligible to the trial,
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 88
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Patients under treatment by inlet diuretic either at the time of the study or before,
- •-Patients with electrolytic disorders,
- •-Patients with a known hypersensitivity to sulfa drugs,
- •-Patients with a hepatic or renal failure,
- •-Patients for whom the CARS results are strictly inferior to 30,
- •-Patients with an epilepsy not controlled by a treatment (comitial crisis in the past 6 month at the time the trial starts despite a treatment),
- •-Patients under treatment by psychotropic exception made of the melatonin,
- •-Allergy to the bumetanide or one of its excipients,
- •-Patient under a treatment by lithium, diphémanil, érythromycine IV, halofantrine, pentamidine, sultopride,
- •-pregnant and lactating women.
- •Secondary exclusion criteria:
- •- QT prolongation noticed on the ECG at Day0,
- •- Anomaly on the biological check up (Day 0) made before including the patient that would contraindicated the prescription of bumétanide,
- •- Patients for whom the CARS results are strictly inferior to 30.
研究者
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