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Efficiency of Bumetanide in Autistic Children

Information source: University Hospital, Brest
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Autistics Children

Intervention: bumetanide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University Hospital, Brest

Official(s) and/or principal investigator(s):
Eric LEMONNIER, Dr, Principal Investigator, Affiliation: CHRU de Brest

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

Clinical Details

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

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

Primary outcome: Child Autism Rating Scale score

Secondary outcome:

Clinical global impressions score

Repetitive end restricted behavior score

GRAM score

Eligibility

Minimum age: 3 Years. Maximum age: 10 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Lemonnier, Brest 29609, France

Chevreuil, Rennes 35703, France

DUPIN, Vannes 56000, France

Additional Information

Starting date: March 2010
Last updated: December 20, 2011

Page last updated: August 20, 2015

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