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Completed

NCT Number: NCT01078714

Efficiency of Bumetanide in Autistic Children

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

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Key information

Conditions

Autistics Children Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Lemonnier, Brest, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bumetanide

Drug

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

Primary outcomes

  1. Child Autism Rating Scale score

    Time frame: day 0 to day 90

Secondary outcomes

  1. Clinical global impressions score

    Time frame: day 0 to day 90

  2. Repetitive end restricted behavior score

    Time frame: day 0 to day 90

  3. GRAM score

    Time frame: day 0 to day 90

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Sponsors and collaborators

Lead sponsor

University Hospital, Brest

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Registry information

Official study title

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

Acronym: BUMEA

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 2, 2010
Registry last updated
Dec 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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