Efficiency of Bumetanide in Autistic Children | NCT01078714

Studies
Efficiency of Bumetanide in Autistic Children

NCT01078714

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Dec 21, 2011Estimated

Enrollment

60Actual

Phase

Phase 3

Conditions

Autistics Children

Interventions

bumetanide

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Mar 1, 2010

First Submission Date that Met QC Criteria

Mar 1, 2010

First Posted Date

Mar 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 20, 2011

Last Update Posted Date

Dec 21, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bumetanide	Experimental		Drug: bumetanide
Control	Placebo Comparator		Drug: bumetanide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bumetanide	Drug	Administration by oral route in 2 times (in the morning and evening) of 0.5 mg by taking (= 1 mg by 24 hours)	Bumetanide Control

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric LEMONNIER, Dr	CHRU de Brest	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lemonnier		Brest		29609	France
Chevreuil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23233021	Derived	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.

ID	Term
D000067877	Autism Spectrum Disorder
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D062368	meta-Aminobenzoates