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

• Status: Withdrawn
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Limoges
• Treatments: Bumetanide

Criteria

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.