Efficiency of Bumetanide in Autistic Children

Phase 3

Completed

• Conditions: Autistics Children
• Interventions: Drug: bumetanide

• Registration Number: NCT01078714
• Lead Sponsor: University Hospital, Brest

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-01
• Study First Submitted QC: 2010-03-01
• Study First Posted: 2010-03-02
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-20
• Last Update Posted: 2011-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bumetanide	bumetanide	-
Control	bumetanide	-

Primary Outcome Measures

Name	Time	Method
Child Autism Rating Scale score	day 0 to day 90

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

DUPIN; 🇫🇷 Vannes, France

Lemonnier; 🇫🇷 Brest, France

Chevreuil; 🇫🇷 Rennes, France