Efficiency of Bumetanide in Autistic Children

NCT ID: NCT01078714

Last Updated: 2011-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autistics Children

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Autism Bumetanide GABA NKCC1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bumetanide

Group Type EXPERIMENTAL

bumetanide

Intervention Type DRUG

Administration by oral route in 2 times (in the morning and evening) of 0.5 mg by taking (= 1 mg by 24 hours)

Control

Group Type PLACEBO_COMPARATOR

bumetanide

Intervention Type DRUG

Administration by oral route in 2 times (in the morning and evening) of 0.5 mg by taking (= 1 mg by 24 hours)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

bumetanide

Administration by oral route in 2 times (in the morning and evening) of 0.5 mg by taking (= 1 mg by 24 hours)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eric LEMONNIER, Dr

Role: PRINCIPAL_INVESTIGATOR

CHRU de Brest

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Lemonnier

Brest, , France

Site Status

Chevreuil

Rennes, , France

Site Status

DUPIN

Vannes, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 23233021 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RB09-017

Identifier Type: -

Identifier Source: org_study_id