No registrations found.
ID
Source
Brief title
Health condition
Autism Spectrum Disorders (ASDs); Epilepsy
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Aberrant Behavior Checklist (ABC) Irritability Subscale
Secondary outcome
- World Health Organization Quality of life (WHOQOL-BREF)
- EQ5D-5L; EQ5D-Youth
- BRIEF
- Productivity Cost Questionnaire (iPCQ)
- Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P)
- ABC sub scales
- Repetitive Behavior Scale (RBS-V)
- Social Responsiveness Scale (SRS)
- Sensory Profile (SP-NL)
- SP School Sompanion (SP-SC)
Epilepsy related variables (if applicable)
- Seizure frequency
- Number of occasions rescue medication is necessary
Background summary
This is a multicenter, double-blind, randomized, placebo-controlled trial testing the effectiveness of three months bumetanide treatment in 172 children aged 5 to 15 years with ASD, with or without epilepsy. The primary endpoint is change in the ABC-I scale at Day 91. Usual care + bumetanide will be compared with usual care + placebo. Participants will be included in Groningen and Utrecht (the Netherlands).
Study objective
To confirm that twelve weeks of add-on treatment with bumetanide will improve daily life functioning and reduce behavioral symptoms related to hyperexcitability in children and adolescents with autism spectrum disorder and/or epilepsy.
Study design
Pre-treatment and screening (D-30 to Day0)
o Screening for eligibility
o Baseline measurements (all primary and secondary outcomes, except iPCQ and TiC-P)
Treatment (D0 to D91)
o Blood analysis at D4, D7, D14, D28, D56
o End of treatment outcome measurements D91 (all primary and secondary outcomes)
Washout (D91 to D119)
o End of washout outcome measurements D119 (all primary and secondary outcomes, except iPCQ and TiC-P)
Intervention
The investigational product (IP) consists of bumetanide 0.5 mg tablets or placebo, which will be provided as an add-on treatment, supplementary to the regular use of AEDs or other (allowed) comedications. Dose reductions to manage side effects will be allowed at any time. Due to the expected chance of frequent mild to moderate hypokalemia, all subjects will receive standard potassium supplementation during the 91 days of treatment. The treatment period will be followed by a wash-out period to evaluate return of symptomatology and reversibility of treatment effect.
Placebo product will be administered as comparator of the Bumetanide in exact similar tablets. The qualitative and quantitative composition in excipients of the Placebo product is comparable to that of Bumetanide 0.5 mg tablets.
D.M. van Andel
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31(0)88-7550776
D.M.vanandel@umcutrecht.nl
D.M. van Andel
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31(0)88-7550776
D.M.vanandel@umcutrecht.nl
Inclusion criteria
1. Males and females aged 5-15 years
2. Above ASD cut-off scores on the Social Responsiveness Scale and either a clinical
ASD diagnosis based on DSM-5 (or DSM-IV) or an epilepsy diagnosis
3. Written informed consent
Exclusion criteria
1. Total IQ<55
2. Presence of a severe medical or genetic disorder other than related to ASD or epilepsy
3. Serious, unstable illnesses
4. Renal insufficiency, congenital or acquired renal disease with decreased concentration capacity and liver insufficiency
5. Behavioral treatment;
6. Treatment with psychoactive medications, including antipsychotics and AEDs, except methylphenidate, is allowed;
7. Treatment with NSAIDS, aminoglycosides, digitals, antihypertensive agents, indomethacin, probenecid, acetazolamide, Lithium, other diuretics, drugs known to have a nephrotoxic potential;
8. Documented history of hypersensitivity reaction to sulfonamide derivatives
9. Body weight <17 kg
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6178 |
| NTR-old | NTR6325 |
| CCMO | NL58621.041.16 |
| OMON | NL-OMON45411 |