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