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Efficiency of Bumetanide in Autistic Children (BUMEA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01078714
First received: March 1, 2010
Last updated: December 20, 2011
Last verified: December 2011
History of Changes
  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
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:

MedlinePlus related topics: Autism
Drug Information available for: Bumetanide
U.S. FDA Resources

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)

  Eligibility

Ages Eligible for Study:   3 Years to 10 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University Hospital, Brest

Additional 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:
Autism
Bumetanide
GABA
NKCC1

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Bumetanide
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013