Autistic DisorderPhase 2BUMAUTEPNCT02947880
Evaluation of the Efficiency of Treatment by BUMETANIDE on Autistic Children With a Known Ethiology
A Phase 2 study testing Bumetanide in people with Autistic Disorder, run by University Hospital, Limoges at 1 site in France.
Trial summary
During a previous therapeutic trial, investigators showed that the bumetanide improved significantly autism. This trial showed that a therapeutic response was obtained in 75% of cases. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- Bumetanide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2016to Jun 2020
- Phase
- Phase 2
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children and teenager from age 5 to age 17, with a diagnosis of typical autism or Asperger syndrome according to the criteria of diagnosis of the WHO's classification (CIM-10),
- With a known etiology,
- Patients for whom the CARS results are strictly Superior or equal to 30,
- Of whom the parents have given their free, informed and written consent,
- Affiliated or beneficiary of the French social security.
Who cannot join
- Patients under treatment by inlet diuretic either at the time of the study or before,
- Patients with electrolytic disorders,
- Patients with a known hypersensitivity to sulfa drugs,
- Patients with a hepatic or renal failure,
- Patients with an epilepsy not controlled by a treatment (comitial crisis in the past 6 month at the time the trial starts despite a treatment),
- Patients under treatment by psychotropic exception made of the melatonin,
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- Allergy to the bumetanide or one of its excipients,
- Patient under a treatment by lithium, diphemanil, erythromycin IV, halofantrine, pentamidine, sultopride, vincamine, aminoglycoside,
- Pregnant and lactating women.
- Secondary exclusion criteria:
- QT prolongation noticed on the ECG at Day0,
- Anomaly on the biological check up (Day 0) made before including the patient that would contraindicated the prescription of bumetanide,
- Patients for whom the CARS results are strictly inferior to 30.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficiency of Treatment by BUMETANIDE on Autistic Children With a Known Ethiology : Multicenter and Double Blind-study With Randomized Parallel Group, Against Placebo.
During a previous therapeutic trial, investigators showed that the bumetanide improved significantly autism. This trial showed that a therapeutic response was obtained in 75% of cases.
These first results were reinforced by a study led with adult patients for whom the eye tracking measurements as well as the functional MRI showed a diminution of the response time and a modification (amplification) of the cerebral response during an emotions recognition test.
Finally, investigators confirmed the physiological mechanism behind the action of the bumetanide in a study in two mouse models of autism.
- Conditions
- Autistic Disorder
- Being tested
- Bumetanide, Placebo
- Keywords
- autism, Bumetanide
- 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
For the patient of 25kg and more the bumetanide is used at the posology of 1mg in the morning and 1mg in the evening, for patient under 25kg the posology is 0.5mg in the morning and 0.5mg in the evening.
PlaceboDrug
For the patient of 25kg and more the placebo is used at the posology of 1mg in the morning and 1mg in the evening, for patient under 25kg the posology is 0.5mg in the morning and 0.5mg in the evening.
| Study group | Role | What they receive |
|---|---|---|
| Bumetanide group | Experimental | During 3 months in the double blind, the patient will receive the experimental treatment. For the patient of 25kg and more the bumetanide is used at the posology of 1mg in the morning and 1mg in the evening, for patient under 25kg the posology is 0.5mg in the morning and 0.5mg in the evening.
After the 3 months in the double blind trial (bumetanide versus placebo), all the patient will receive (in the open phase of the trial) the bumetanide during 3 months with the posology fitting with their weights. Receives: Drug: Bumetanide |
| Placebo group | Placebo comparator | During 3 months in the double blind, the patient will receive the placebo. For the patient of 25kg and more the bumetanide is used at the posology of 1mg in the morning and 1mg in the evening, for patient under 25kg the posology is 0.5mg in the morning and 0.5mg in the evening.
After the 3 months in the double blind trial (bumetanide versus placebo), all the patient will receive (in the open phase of the trial) the bumetanide during 3 months with the posology fitting with their weights. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change (evolution) between day 0 and day 99 of the result of the scale CARS (Childhood Autism Rating Scale).
Measured: Day 0 and Day 99
Secondary outcomes (1)
CARS (Childhood Autism Rating Scale) between D0 and D99 and between D99 and D190 which will be describe by etiology
Measured: Day 0, Day 99 and Day 190
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2019
- Study completionJun 2020
Why it stopped: the recently feasibility study shows that the number of patients is insufficient in the centers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947880
- Sponsor's protocol ID
- I14039
- Acronym
- BUMAUTEP
- Status last verified
- Aug 2017
- First submitted
- 25 Oct 2016
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of Treatment by BUMETANIDE on Autistic Children With a Known Ethiology : Multicenter and Double Blind-study With Randomized Parallel Group, Against Placebo.
- ClinicalTrials.gov ID
- NCT02947880
- Acronym / sponsor ID
- BUMAUTEP / I14039
- Conditions
- Autistic Disorder
- Keywords
- autism, Bumetanide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the recently feasibility study shows that the number of patients is insufficient in the centers
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 28 Oct 2016 (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.
During a previous therapeutic trial, investigators showed that the bumetanide improved significantly autism. This trial showed that a therapeutic response was obtained in 75% of cases.
These first results were reinforced by a study led with adult patients for whom the eye tracking measurements as well as the functional MRI showed a diminution of the response time and a modification (amplification) of the cerebral response during an emotions recognition test.
Finally, investigators confirmed the physiological mechanism behind the action of the bumetanide in a study in two mouse models of autism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bumetanide group | Experimental | Drug: BumetanideDuring 3 months in the double blind, the patient will receive the experimental treatment. For the patient of 25kg and more the bumetanide is used at the posology of 1mg in the morning and 1mg in the evening, for patient under 25kg the posology is 0.5mg in the morning and 0.5mg in the evening. After the 3 months in the double blind trial (bumetanide versus placebo), all the patient will receive (in the open phase of the trial) the bumetanide during 3 months with the posology fitting with their weights. |
| Placebo group | Placebo comparator | Drug: PlaceboDuring 3 months in the double blind, the patient will receive the placebo. For the patient of 25kg and more the bumetanide is used at the posology of 1mg in the morning and 1mg in the evening, for patient under 25kg the posology is 0.5mg in the morning and 0.5mg in the evening. After the 3 months in the double blind trial (bumetanide versus placebo), all the patient will receive (in the open phase of the trial) the bumetanide during 3 months with the posology fitting with their weights. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children and teenager from age 5 to age 17, with a diagnosis of typical autism or Asperger syndrome according to the criteria of diagnosis of the WHO's classification (CIM-10),
- With a known etiology,
- Patients for whom the CARS results are strictly Superior or equal to 30,
- Of whom the parents have given their free, informed and written consent,
- Affiliated or beneficiary of the French social security.
Key exclusion criteria (13 listed)
- Patients under treatment by inlet diuretic either at the time of the study or before,
- Patients with electrolytic disorders,
- Patients with a known hypersensitivity to sulfa drugs,
- Patients with a hepatic or renal failure,
- Patients with an epilepsy not controlled by a treatment (comitial crisis in the past 6 month at the time the trial starts despite a treatment),
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 |
|---|---|---|
| BumetanideFor the patient of 25kg and more the bumetanide is used at the posology of 1mg in the morning and 1mg in the evening, for patient under 25kg the posology is 0.5mg in the morning and 0.5mg in the evening. | Drug | Bumetanide group |
| PlaceboFor the patient of 25kg and more the placebo is used at the posology of 1mg in the morning and 1mg in the evening, for patient under 25kg the posology is 0.5mg in the morning and 0.5mg in the evening. | Drug | Placebo group |
Primary outcome
Change (evolution) between day 0 and day 99 of the result of the scale CARS (Childhood Autism Rating Scale).
Time frame: Day 0 and Day 99
1 secondary outcome
CARS (Childhood Autism Rating Scale) between D0 and D99 and between D99 and D190 which will be describe by etiology
Time frame: Day 0, Day 99 and Day 190
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bumetanide in people with Autistic Disorder, run by University Hospital, Limoges at 1 site 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 5 inclusion and 13 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: withdrawn, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change (evolution) between day 0 and day 99 of the result of the scale CARS (Childhood Autism Rating Scale). (time frame: Day 0 and Day 99). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2026.