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Bumetanide for the Autism Spectrum Clinical Effectiveness Trial

Bumetanide for the Autism Spectrum Clinical Effectiveness Trial - BASCET

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45411
Enrollment
172
Registered
2016-08-16
Start date
2017-06-21
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD Autism Autism Spectrum Disorders epilepsy

Interventions

Patients will be treated (randomly) with bumetanide or placebo, for 91 days, followed by 28 days of wash-out. Bumetanide or placebo can be used as add-on treatment in addition to the regular use of

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

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

Exclusion criteria: 1. Total IQ 13y); 4. Renal insufficiency (CKD st2-5; estimated glomerular filtration rate

Design outcomes

Primary

MeasureTime frame
The primary study parameters is the Aberrant Behavior Checklist-Irritability subscale.

Secondary

MeasureTime frame
Secondary study parameters are behavioral and quality of life parameters and seizure frequency

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)