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Withdrawn NCT02947880

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

Conditions: Autistic Disorder

Sex: All
Ages: 5 Years – 17 Years
Healthy volunteers: No
Phase: PHASE2
Sponsor: University Hospital, Limoges

Location: CHU de Limoges Limoges

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.

Eligibility 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT02947880). StuddyBuddy aggregates publicly available trial information.