EVALUATION OF THE EFFICIENCY OF TREATMENT BY BUMETANIDE ON AUTISTIC CHILDREN WITH A KNOWN ETIOLOGY: MULTICENTER AND DOUBLE-BLIND STUDY WITH RANDOMIZED PARALLEL GROUP, AGAINST PLACEBO.
- Conditions
- autismMedDRA version: 19.0 Level: PT Classification code 10003805 Term: Autism System Organ Class: 10029205 - Nervous system disordersTherapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]
- Registration Number
- EUCTR2016-000106-11-FR
- Lead Sponsor
- imoges Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 88
- 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
-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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method