Efficiency of Bumetanide in Autistic Children

Autistics Children Clinical Trial

— BUMEA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01078714
• Other study ID #: RB09-017
• Status: Completed
• Phase: Phase 3
• First received: March 1, 2010
• Last updated: December 20, 2011
• Start date: March 2010
• Est. completion date: June 2011

Study information

• Verified date: December 2011
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 10 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autistic Disorder
• Autistics Children

Intervention

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)

Locations

Country	Name	City	State
France	Lemonnier	Brest
France	Chevreuil	Rennes
France	DUPIN	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Autism Rating Scale score		day 0 to day 90	No
Secondary	Clinical global impressions score		day 0 to day 90	No
Secondary	Repetitive end restricted behavior score		day 0 to day 90	No
Secondary	GRAM score		day 0 to day 90	No