Clinical trial NCT02947880: Evaluation of the Efficiency of Treatment by BUMETANIDE on Autistic Children With a Known Ethiology
Official title: 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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Autistic Disorder
Keywords: autism, Bumetanide
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2016-10-28
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Change (evolution) between day 0 and day 99 of the result of the scale CARS (Childhood Autism Rating Scale).
timeFrame: Day 0 and Day 99
Secondary outcomes:
measure: CARS (Childhood Autism Rating Scale) between D0 and D99 and between D99 and D190 which will be describe by etiology
timeFrame: Day 0, Day 99 and Day 190
Other outcomes:
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Study officials:
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