Efficiency of Bumetanide in Autistic Children (BUMEA)

December 20, 2011 updated by: University Hospital, Brest

Study of the Efficiency of a Treatment by Bumetanide in a Population of Autistic Children

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • Lemonnier
      • Rennes, France, 35703
        • Chevreuil
      • Vannes, France, 56000
        • DUPIN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Child Autism Rating Scale score
Time Frame: day 0 to day 90
day 0 to day 90

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical global impressions score
Time Frame: day 0 to day 90
day 0 to day 90
Repetitive end restricted behavior score
Time Frame: day 0 to day 90
day 0 to day 90
GRAM score
Time Frame: day 0 to day 90
day 0 to day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Principal Investigator: Eric LEMONNIER, Dr, CHRU de Brest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

March 1, 2010

First Submitted That Met QC Criteria

March 1, 2010

First Posted (Estimate)

March 2, 2010

Study Record Updates

Last Update Posted (Estimate)

December 21, 2011

Last Update Submitted That Met QC Criteria

December 20, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RB09-017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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