Bumetanide in Autism Medication and Biomarker study

Bumetanide in Autism Medication and Biomarker study - BAMBI

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44696

Enrollment

Registered

2017-09-27

Start date

2016-06-21

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

autism autism spectrum disorders

Interventions

Patients will be treated with bumetanide according to a titration period twice daily or placebo, in the form of syrup, for 91 days followed by a 28-day washout after each treatment period. For pati

autism spectrum disorder

bumetanide

chloride

treatment

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1. Males or females aged *7 years to *15 years; 2. Criteria met for autism spectrum disorder and on DSM-V Social Responsiveness Scale (SRS) (24). 3. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Total IQ

Design outcomes

Primary

Measure	Time frame
Primary endpoints will be the change in score on Social Responsiveness Scale (SRS).	—

Secondary

Measure	Time frame
Secondary endpoints will involve adaptive skill assessments; behavioral symptoms relating to rigidity; sensory modulation profiles , resting state EEG, sensory evoked EEG paradigms (ERP) and genetic analysis to predict treatment response.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)