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: 2019年12月10日

适应症

试验速览

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•- 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

•-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.

发起方

imoges Hospital