Autistics ChildrenPhase 3BUMEANCT01078714
Efficiency of Bumetanide in Autistic Children
A Phase 3 study testing bumetanide in people with Autistics Children, run by University Hospital, Brest at 3 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Autistics Children
- What is being tested?
- bumetanide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesFrance
- Study dates
- Mar 2010to Jun 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: 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
- Conditions
- Autistics Children
- Being tested
- bumetanide
- Keywords
- Autism, Bumetanide, GABA, NKCC1
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bumetanideDrug
Administration by oral route in 2 times (in the morning and evening) of 0.5 mg by taking (= 1 mg by 24 hours)
| Study group | Role | What they receive |
|---|---|---|
| Bumetanide | Experimental | Not described Receives: Drug: bumetanide |
| Control | Placebo comparator | Not described Receives: Drug: bumetanide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Autism Rating Scale score
Measured: day 0 to day 90
Secondary outcomes (3)
Clinical global impressions score
Measured: day 0 to day 90
Repetitive end restricted behavior score
Measured: day 0 to day 90
GRAM score
Measured: day 0 to day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autistics ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric LEMONNIER, Dr, Principal investigator, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078714
- Sponsor's protocol ID
- RB09-017
- Acronym
- BUMEA
- Status last verified
- Dec 2011
- First submitted
- 1 Mar 2010
- Last updated
- 21 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23233021
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficiency of a Treatment by Bumetanide in a Population of Autistic Children
- ClinicalTrials.gov ID
- NCT01078714
- Acronym / sponsor ID
- BUMEA / RB09-017
- Conditions
- Autistics Children
- Keywords
- Autism, Bumetanide, GABA, NKCC1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bumetanide | Experimental | Drug: bumetanide |
| Control | Placebo comparator | Drug: bumetanide |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bumetanideAdministration by oral route in 2 times (in the morning and evening) of 0.5 mg by taking (= 1 mg by 24 hours) | Drug | Bumetanide, Control |
Primary outcome
Child Autism Rating Scale score
Time frame: day 0 to day 90
3 secondary outcomes
Clinical global impressions score
Time frame: day 0 to day 90
Repetitive end restricted behavior score
Time frame: day 0 to day 90
GRAM score
Time frame: day 0 to day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2011.
- Derived from this study: PubMed 23233021Lemonnier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric LEMONNIER, Dr principal investigator
CHRU de Brest
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bumetanide in people with Autistics Children, run by University Hospital, Brest at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Autism Rating Scale score (time frame: day 0 to day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01078714, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2011.