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 scoreRepetitive 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
|