Efficiency of Bumetanide in Autistic Children (BUMEA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01078714
Recruitment Status : Completed
First Posted : March 2, 2010
Last Update Posted : December 21, 2011
Information provided by (Responsible Party):
University Hospital, Brest

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

Condition or disease Intervention/treatment Phase
Autistics Children Drug: bumetanide Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study of the Efficiency of a Treatment by Bumetanide in a Population of Autistic Children
Study Start Date : March 2010
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Bumetanide
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Bumetanide Drug: bumetanide
Administration by oral route in 2 times (in the morning and evening) of 0.5 mg by taking (= 1 mg by 24 hours)
Placebo Comparator: Control Drug: bumetanide
Administration by oral route in 2 times (in the morning and evening) of 0.5 mg by taking (= 1 mg by 24 hours)

Primary Outcome Measures :
  1. Child Autism Rating Scale score [ Time Frame: day 0 to day 90 ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01078714

Brest, France, 29609
Rennes, France, 35703
Vannes, France, 56000
Sponsors and Collaborators
University Hospital, Brest
Principal Investigator: Eric LEMONNIER, Dr CHRU de Brest

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital, Brest Identifier: NCT01078714     History of Changes
Other Study ID Numbers: RB09-017
First Posted: March 2, 2010    Key Record Dates
Last Update Posted: December 21, 2011
Last Verified: December 2011

Keywords provided by University Hospital, Brest:

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action