BUMEA: Efficiency of Bumetanide in Autistic Children

Sponsor

University Hospital, Brest (Other)

Overall Status

Completed

CT.gov ID

NCT01078714

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if a treatment by bumetanide presents an efficiency at the level of the neuronal maturation in the autism

Condition or Disease	Intervention/Treatment	Phase
Autistics Children	Drug: bumetanide	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Study of the Efficiency of a Treatment by Bumetanide in a Population of Autistic Children

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bumetanide	Drug: bumetanide Administration by oral route in 2 times (in the morning and evening) of 0.5 mg by taking (= 1 mg by 24 hours)
Placebo Comparator: Control	Drug: bumetanide Administration by oral route in 2 times (in the morning and evening) of 0.5 mg by taking (= 1 mg by 24 hours)

Arm

Intervention/Treatment

Experimental: Bumetanide

Drug: bumetanide

Administration by oral route in 2 times (in the morning and evening) of 0.5 mg by taking (= 1 mg by 24 hours)

Placebo Comparator: Control

Drug: bumetanide

Administration by oral route in 2 times (in the morning and evening) of 0.5 mg by taking (= 1 mg by 24 hours)

Outcome Measures

Primary Outcome Measures

Child Autism Rating Scale score [day 0 to day 90]

Secondary Outcome Measures

Clinical global impressions score [day 0 to day 90]
Repetitive end restricted behavior score [day 0 to day 90]
GRAM score [day 0 to day 90]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Children from 3 to 10 years old, answering the diagnosis of typical autism according to the diagnostic criteria of autism of the classification of the WHO ( CIM-10) and the parents of which gave a free, enlightened and written consent.

Exclusion Criteria:

Patients epileptic autistics treated by anticomitiaux or having hurts of the central nervous system
Patients autistics receiving a psychotropic treatment
Patients presenting disorders electrolytes
Patients presenting a hypersensibility known about sulpha drugs
Presenting patients against indications relative to the treatment by bumetanide
Patients already treated by diuretics
Patients presenting a hepatic or renal incapacity
Patients presenting an elongation of the QT to the electrocardiogram.
Patients autistics of CARS sore is lower than 30.