autism MedDRA version: 19.0 Level: PT Classification code 10003805 Term: Autism System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: BURINEX 1mg, tablet
Pharmaceutical Form: Syrup
INN or Proposed INN: BUMETANIDE
Other descriptive name: BUMETANIDE
Pharmaceut
Sponsors
Limoges Hospital
Eligibility
Sex/Gender
All
Inclusion 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, - Of whom the parents have given their free, informed and written consent, - Affiliated or beneficiary of the French social security. NB: Patient taking melatonin and stabilized are eligible to the trial, Patient with a stabilized epilepsy by treatment (no comitial crisis for the 6 months before entering the trial) are eligible to the trial, Are the trial subjects under 18? yes Number of subjects for this age range: 88 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 for whom the CARS results are strictly inferior to 30, -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, diphémanil, érythromycine IV, halofantrine, pentamidine, sultopride, -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 bumétanide, - Patients for whom the CARS results are strictly inferior to 30.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the effectiveness of bumetanide treatment on the intensity of young autistic disorders with known etiology, as measured by changes in the score CARS (Childhood Autism Rating Scale) between D0 (inclusion) and D99 (after 3 first months of treatment).; Secondary Objective: - Describe the evolution of the CARS score between 0 and D99, D99 and D190 (3 months + 3 months) in the etiology of autism. - Determine the safety profile of the experimental treatment ;Primary end point(s): The evolution of the result of the CARS (evaluation scale of the intensity of autism in child autism) between day 0 and day 99.;Timepoint(s) of evaluation of this end point: 2 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) CARS between D0 and D99 and between D99 and D190 which will be describe by etiology. 2) Analysis of adverse events which happened during the study (comparison of the two groups between D0 and D99, and analysis of the adverse events that occurred with subjects taking the Bumetanide between D0 and D190). The adverse events will be of a clinical and biological nature. ;Timepoint(s) of evaluation of this end point: 3 days | — |
Countries
France
Contacts
Public ContactDirector of Research
Limoges Hospital
Outcome results
None listed