Efficiency of Bumetanide in Autistic Children (BUMEA)

Regional University Hospital Center (CHRU)

Status and phase: Completed; Phase 3

Conditions: Autistics Children

Treatments: Drug: bumetanide

Study type: Interventional

Funder types: Other

Identifiers

NCT01078714

RB09-017

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 3 to 10 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Bumetanide

Experimental group

Treatment:

Drug: bumetanide

Control

Placebo Comparator group

Treatment:

Drug: bumetanide