Efficiency of Bumetanide in Autistic Children
BUMEA
Study of the Efficiency of a Treatment by Bumetanide in a Population of Autistic Children
1 other identifier
interventional
60
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2010
Shorter than P25 for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedFirst Posted
Study publicly available on registry
March 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedDecember 21, 2011
December 1, 2011
1.3 years
March 1, 2010
December 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Child Autism Rating Scale score
day 0 to day 90
Secondary Outcomes (3)
Clinical global impressions score
day 0 to day 90
Repetitive end restricted behavior score
day 0 to day 90
GRAM score
day 0 to day 90
Study Arms (2)
Bumetanide
EXPERIMENTALControl
PLACEBO COMPARATORInterventions
Administration by oral route in 2 times (in the morning and evening) of 0.5 mg by taking (= 1 mg by 24 hours)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Lemonnier
Brest, 29609, France
Chevreuil
Rennes, 35703, France
DUPIN
Vannes, 56000, France
Related Publications (1)
Lemonnier E, Degrez C, Phelep M, Tyzio R, Josse F, Grandgeorge M, Hadjikhani N, Ben-Ari Y. A randomised controlled trial of bumetanide in the treatment of autism in children. Transl Psychiatry. 2012 Dec 11;2(12):e202. doi: 10.1038/tp.2012.124.
PMID: 23233021DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric LEMONNIER, Dr
CHRU de Brest
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2010
First Posted
March 2, 2010
Study Start
March 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
December 21, 2011
Record last verified: 2011-12