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Efficiency of Bumetanide in Autistic Children (BUMEA)

Primary Purpose

Autistics Children

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
bumetanide
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autistics Children focused on measuring Autism, Bumetanide, GABA, NKCC1

Eligibility Criteria

3 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lemonnier
  • Chevreuil
  • DUPIN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bumetanide

Control

Arm Description

Outcomes

Primary Outcome Measures

Child Autism Rating Scale score

Secondary Outcome Measures

Clinical global impressions score
Repetitive end restricted behavior score
GRAM score

Full Information

First Posted
March 1, 2010
Last Updated
December 20, 2011
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT01078714
Brief Title
Efficiency of Bumetanide in Autistic Children
Acronym
BUMEA
Official Title
Study of the Efficiency of a Treatment by Bumetanide in a Population of Autistic Children
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistics Children
Keywords
Autism, Bumetanide, GABA, NKCC1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bumetanide
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
bumetanide
Intervention Description
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 Measure Information:
Title
Child Autism Rating Scale score
Time Frame
day 0 to day 90
Secondary Outcome Measure Information:
Title
Clinical global impressions score
Time Frame
day 0 to day 90
Title
Repetitive end restricted behavior score
Time Frame
day 0 to day 90
Title
GRAM score
Time Frame
day 0 to day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric LEMONNIER, Dr
Organizational Affiliation
CHRU de Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lemonnier
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Chevreuil
City
Rennes
ZIP/Postal Code
35703
Country
France
Facility Name
DUPIN
City
Vannes
ZIP/Postal Code
56000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
23233021
Citation
Lemonnier E, Degrez C, Phelep M, Tyzio R, Josse F, Grandgeorge M, Hadjikhani N, Ben-Ari Y. A randomised controlled trial of bumetanide in the treatment of autism in children. Transl Psychiatry. 2012 Dec 11;2(12):e202. doi: 10.1038/tp.2012.124.
Results Reference
derived

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Efficiency of Bumetanide in Autistic Children

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