Efficiency of Bumetanide in Autistic Children (BUMEA)

This study has been completed.
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
First received: March 1, 2010
Last updated: December 20, 2011
Last verified: December 2011
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical global impressions score [ Time Frame: day 0 to day 90 ] [ Designated as safety issue: No ]
  • Repetitive end restricted behavior score [ Time Frame: day 0 to day 90 ] [ Designated as safety issue: No ]
  • GRAM score [ Time Frame: day 0 to day 90 ] [ Designated as safety issue: No ]

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)


Ages Eligible for Study:   3 Years to 10 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078714

Brest, France, 29609
Rennes, France, 35703
Vannes, France, 56000
Sponsors and Collaborators
University Hospital, Brest
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 
Study First Received: March 1, 2010
Last Updated: December 20, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Brest:

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

ClinicalTrials.gov processed this record on May 26, 2016