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van CCT (UK)

van CCT (UK)

Bumetanide for the Autism Spectrum Clinical Effectiveness Trial

- candidate number26461
- NTR NumberNTR6325
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-jan-2017
- Secondary IDsNL58621.041.16 METC: 16-475
- Public TitleBumetanide for the Autism Spectrum Clinical Effectiveness Trial
- Scientific TitleBumetanide for the Autism Spectrum Clinical Effectiveness Trial
- hypothesisTo 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.
- Healt Condition(s) or Problem(s) studiedAutism Spectrum Disorders (ASDs), Epilepsy
- Inclusion criteria1. 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 criteria1. 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2017
- planned closingdate1-mrt-2019
- Target number of participants172
- InterventionsThe 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.
- Primary outcome- Aberrant Behavior Checklist (ABC) Irritability Subscale
- Secondary outcome- World Health Organization Quality of life (WHOQOL-BREF)
- EQ5D-5L; EQ5D-Youth
- 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
- TimepointsPre-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)
- Trial web site
- statusplanned
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Dutch Brain Foundation (Hersenstichting)
- Publications
- Brief summaryThis 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).
- Main changes (audit trail)
- RECORD13-jan-2017 - 28-mei-2017

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