Bumetanide for the Autism Spectrum Clinical Effectiveness Trial

Phase 2

Completed

• Conditions: ADHD; Autism; Autism Spectrum Disorders; epilepsy; 10057167; 10012562

• Registration Number: NL-OMON45411
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2021-02-09
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 172

Inclusion Criteria

1. Males or females aged *5 years to *15 years;
2. Above clinical cut-off scores 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.

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. Presence of a severe medical or genetic disorder other than related to ASD or epilepsy;
3. Serious, unstable illnesses including, gastroenterological, respiratory, cardiovascular (arrhythmias, QT interval lengthening), endocrinologic, immunologic, hematologic disease, dehydration or hypotension, electrolyte disturbances (Na <133 mmol/L, K <3.5 mmol/L or Ca <2.17 mmol/L (<13y) or <2.2 mmol/L (>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 treatmen during studyt;
6. Treatment with psychoactive medications, including antipsychotics 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameters is the Aberrant Behavior Checklist-Irritability<br /><br>subscale. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are behavioral and quality of life parameters and<br /><br>seizure frequency</p><br>