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

NCT ID: NCT02947880

Last Updated: 2021-06-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2020-06-30

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.

Conditions

Autistic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Bumetanide group

During 3 months in the double blind, the patient will receive the experimental treatment. For the patient of 25kg and more the bumetanide is used at the posology of 1mg in the morning and 1mg in the evening, for patient under 25kg the posology is 0.5mg in the morning and 0.5mg in the evening.

After the 3 months in the double blind trial (bumetanide versus placebo), all the patient will receive (in the open phase of the trial) the bumetanide during 3 months with the posology fitting with their weights.

Group Type: EXPERIMENTAL

Bumetanide

Intervention Type: DRUG

For the patient of 25kg and more the bumetanide is used at the posology of 1mg in the morning and 1mg in the evening, for patient under 25kg the posology is 0.5mg in the morning and 0.5mg in the evening.

Placebo group

During 3 months in the double blind, the patient will receive the placebo. For the patient of 25kg and more the bumetanide is used at the posology of 1mg in the morning and 1mg in the evening, for patient under 25kg the posology is 0.5mg in the morning and 0.5mg in the evening.

After the 3 months in the double blind trial (bumetanide versus placebo), all the patient will receive (in the open phase of the trial) the bumetanide during 3 months with the posology fitting with their weights.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

For the patient of 25kg and more the placebo is used at the posology of 1mg in the morning and 1mg in the evening, for patient under 25kg the posology is 0.5mg in the morning and 0.5mg in the evening.

Interventions

Bumetanide

For the patient of 25kg and more the bumetanide is used at the posology of 1mg in the morning and 1mg in the evening, for patient under 25kg the posology is 0.5mg in the morning and 0.5mg in the evening.

Intervention Type: DRUG

Placebo

For the patient of 25kg and more the placebo is used at the posology of 1mg in the morning and 1mg in the evening, for patient under 25kg the posology is 0.5mg in the morning and 0.5mg in the evening.

Intervention Type: DRUG

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.

• 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

I14039

Identifier Type: -

Identifier Source: org_study_id