Evaluation of the Efficiency of Treatment by BUMETANIDE on Autistic Children With a Known Ethiology

Evaluation of the Efficiency of Treatment by BUMETANIDE on Autistic Children With a Known Ethiology : Multicenter and Double Blind-study With Randomized Parallel Group, Against Placebo.

During a previous therapeutic trial, investigators showed that the bumetanide improved significantly autism. This trial showed that a therapeutic response was obtained in 75% of cases.

These first results were reinforced by a study led with adult patients for whom the eye tracking measurements as well as the functional MRI showed a diminution of the response time and a modification (amplification) of the cerebral response during an emotions recognition test.

Finally, investigators confirmed the physiological mechanism behind the action of the bumetanide in a study in two mouse models of autism.

Inclusion Criteria:

• 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,
• Patients for whom the CARS results are strictly Superior or equal to 30,
• Of whom the parents have given their free, informed and written consent,
• Affiliated or beneficiary of the French social security.

Exclusion Criteria:

• 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 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, diphemanil, erythromycin IV, halofantrine, pentamidine, sultopride, vincamine, aminoglycoside,
• 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 bumetanide,
• Patients for whom the CARS results are strictly inferior to 30.