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Evaluation of the Efficiency of Treatment by BUMETANIDE on Autistic Children With a Known Ethiology (BUMAUTEP)

Primary Purpose

Autistic Disorder

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Bumetanide
Placebo
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autistic Disorder focused on measuring autism, Bumetanide

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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,
  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Bumetanide group

    Placebo group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change (evolution) between day 0 and day 99 of the result of the scale CARS (Childhood Autism Rating Scale).

    Secondary Outcome Measures

    CARS (Childhood Autism Rating Scale) between D0 and D99 and between D99 and D190 which will be describe by etiology

    Full Information

    First Posted
    October 25, 2016
    Last Updated
    June 1, 2021
    Sponsor
    University Hospital, Limoges
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02947880
    Brief Title
    Evaluation of the Efficiency of Treatment by BUMETANIDE on Autistic Children With a Known Ethiology
    Acronym
    BUMAUTEP
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    the recently feasibility study shows that the number of patients is insufficient in the centers
    Study Start Date
    December 2016 (Actual)
    Primary Completion Date
    December 2019 (Actual)
    Study Completion Date
    June 2020 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autistic Disorder
    Keywords
    autism, Bumetanide

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bumetanide group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Bumetanide
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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
    Secondary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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, 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.

    12. IPD Sharing Statement

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    Evaluation of the Efficiency of Treatment by BUMETANIDE on Autistic Children With a Known Ethiology

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