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Efficiency of Bumetanide in Autistic Children

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01078714
Acronym
BUMEA
Enrollment
60
Registered
2010-03-02
Start date
2010-03-31
Completion date
2011-06-30
Last updated
2011-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autistics Children

Keywords

Autism, Bumetanide, GABA, NKCC1

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

Interventions

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

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Child Autism Rating Scale scoreday 0 to day 90

Secondary

MeasureTime frame
Clinical global impressions scoreday 0 to day 90
Repetitive end restricted behavior scoreday 0 to day 90
GRAM scoreday 0 to day 90

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026