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Efficiency of Bumetanide in Autistic Children (BUMEA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01078714
First Posted: March 2, 2010
Last Update Posted: December 21, 2011
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.
Information provided by (Responsible Party):
University Hospital, Brest
  Purpose
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 Intervention Phase
Autistics Children Drug: bumetanide Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Brest:

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

Secondary Outcome Measures:
  • Clinical global impressions score [ Time Frame: day 0 to day 90 ]
  • Repetitive end restricted behavior score [ Time Frame: day 0 to day 90 ]
  • GRAM score [ Time Frame: day 0 to day 90 ]

Enrollment: 60
Study Start Date: March 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

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
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01078714


Locations
France
Lemonnier
Brest, France, 29609
Chevreuil
Rennes, France, 35703
DUPIN
Vannes, France, 56000
Sponsors and Collaborators
University Hospital, Brest
Investigators
Principal Investigator: Eric LEMONNIER, Dr CHRU de Brest
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT01078714     History of Changes
Other Study ID Numbers: RB09-017
First Submitted: March 1, 2010
First Posted: March 2, 2010
Last Update Posted: December 21, 2011
Last Verified: December 2011

Keywords provided by University Hospital, Brest:
Autism
Bumetanide
GABA
NKCC1

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