Autism Spectrum Disorder
Conditions
Interventions
Product Name: bumetanide oral solution 0.5mg/ml
Pharmaceutical Form: Syrup
Pharmaceutical form of the placebo: Syrup
Route of administration of the placebo: Oral use
Sponsors
Brain Center Rudolf Magnus, University Medical Center Utrecht, Department of Psychiatry, Utrecht , the Netherlands
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females aged =7 years to =15 years; 2. Criteria met for autism on Autism Diagnostic Observation Schedule - Generic (ADOS G) and Social Responsiveness Scale (SRS) (24). 3. Written informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: 90 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: 1. Total IQ < 55 (WISC) and/or inability to comply with the protocol-specified procedures for the duration of the study, including treatment, blood sampling to control diuretic effects. 2. Serious, unstable illnesses including, gastroenterologic, respiratory, cardiovascular (QT interval lengthening), endocrinologic, immunologic, or hematologic disease; 3. Renal or hepatic dysfunction that would interfere with excretion or metabolism of Bumetanide; 4. Neurological disorders such as epilepsy, seizures and microcephaly; 5. Behavioral treatment 6. Treatment with psychoactive medications, including anticonvulsants, in the last 8 weeks prior to start of the study, except melatonin; no use of other psychoactive substances is allowed from 8 weeks prior to the pre-study evaluation until the endpoint measurements at the end of the washout period. If clinically feasible and desired by the patients and/or parents, then it is allowed to stop psychoactive medication to allow enrollment in the study after a 8 week washout period of their psychoactive medication. 7. Treatment with NSAIDS or aminoglycosides. 8. Documented history of hypersensitivity reaction to sulfonamide derivatives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary aim: to identify prognostic biomarkers of bumetanide treatment using cognitive and neurophysiological assessments. ;Primary end point(s): Social Responsiveness Scale (SRS);Timepoint(s) of evaluation of this end point: Day 91 and day 119.;Main Objective: This study will assess the clinical efficacy of bumetanide using the most common behavioral endpoint scale in ASD trials to establish a first rational treatment concept in ASD that can be administered safely in children and adolescents. Hypotheses 1. Thirteen weeks of treatment with bumetanide will effectively reduce ASD-related behavioral symptoms and improve day-to-day functioning in comparison with usual care. 2. Efficacy of bumetanide is associated with certain cognitive and psychophysiological parameters related to hyperexcitable networks in patients with ASD. Objectives: Primary aim: to investigate whether thirteen weeks treatment with bumetanide will improve daily life functioning and reduce behavioral symptoms in children with ASD in comparison with usual care. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Electroencephalogram (EEG)/ event-related potential (ERP) phenotypes, neurocognitive and other behavioral parameters.;Timepoint(s) of evaluation of this end point: Day 91 and day 119. | — |
Countries
Netherlands
Contacts
Public ContactBrain Center Rudolf Magnus, Univers
Brain Center Rudolf Magnus, University Medical Center Utrecht, Department of Psychiatry, Utrecht , the Netherlands
Outcome results
None listed