Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Epilepsy MedDRA version: 20.0 Level: LLT Classification code 10008520 Term: Childhood autism System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 20.0 Level: PT Classification code 10063844 Term: Autism spectrum disorder System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 20.0 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders MedDRA
Conditions
Interventions
Trade Name: Bumetanide
Product Name: bumetanide
Product Code: bumetanide
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
UMC Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females aged =5 years to =15 years; 2. Above clinical cut-off scores of altered sensory reactivity on the Sensory Profile and either a clinical ASD or ADHD diagnosis based on DSM-5 (or DSM-IV) or an epilepsy diagnosis; 3. Written informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: 172 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 13y); 4. Renal insufficiency (CKD st2-5; estimated glomerular filtration rate < 90 ml/min/1.73m2), congenital or acquired renal disease with decreased concentration capacity (tubulopathy, diabetes insipidus) and liver insufficiency interfering with excretion or metabolism of bumetanide; 5. Start of behavioural treatment during study; 6. Treatment with psychoactive medications, including antipsychotics, psychostimulant drugs and AEDs, except methylphenidate, is allowed albeit on a stable regime in terms of types and dosage from 2 months prior to the study to the end of the study; 7. Treatment with NSAIDS, aminoglycosides, digitals, antihypertensive agents, indomethacin, probenecid, acetazolamide, Lithium, other diuretics (e.g., furosemide, hydrochlorothiazide), drugs known to have a nephrotoxic potential; 8. Documented history of hypersensitivity reaction to sulfonamide derivatives; 9. Body weight <17 kg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Improve behavioral and cognitive dysfunctioning;Secondary Objective: Reduce neuronal hyperexcitability;Primary end point(s): Aberrant Behavior Checklist (ABC) irritability subscale;Timepoint(s) of evaluation of this end point: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Other behavioral and quality of life parameters; seizure frequency.;Timepoint(s) of evaluation of this end point: 3 months | — |
Countries
Netherlands
Contacts
Public ContactDorinde van Andel
UMC Utrecht
Outcome results
None listed