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

Sponsor

University Hospital, Limoges (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02947880

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autistic Disorder	Drug: Bumetanide Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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.
Placebo Comparator: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

Drug: 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.

Placebo Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

Change (evolution) between day 0 and day 99 of the result of the scale CARS (Childhood Autism Rating Scale). [Day 0 and Day 99]

Secondary Outcome Measures

CARS (Childhood Autism Rating Scale) between D0 and D99 and between D99 and D190 which will be describe by etiology [Day 0, Day 99 and Day 190]

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Limoges

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Limoges

ClinicalTrials.gov Identifier:

NCT02947880

Other Study ID Numbers:

I14039

First Posted:

Oct 28, 2016

Last Update Posted:

Jun 2, 2021

Last Verified:

Aug 1, 2017

Keywords provided by University Hospital, Limoges

autism, Bumetanide

Additional relevant MeSH terms:

Autistic Disorder

Bumetanide

Study Results

No Results Posted as of Jun 2, 2021