About the Study
Potential treatment for irritability in autism
The clinical trial is researching an experimental treatment, AB-2004, that is designed to adsorb certain substances produced by bacteria in the gut to reduce their ability to enter the bloodstream and reach the brain. Scientific studies have shown there may be a link between gut bacteria and the brain which could contribute to certain characteristics, such as irritability, in children with Autism Spectrum Disorder (ASD).
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The placebo-controlled study aims to show that lowering the levels of certain substances from bacteria in the gut can improve characteristics, such as irritability, in children with ASD.
PURPOSE
Evaluate a potential new treatment associated with Autism Spectrum Disorder (ASD)
AGE
5-17
GENDER
AT THE CLINIC
When your child visits the study location they will:
Be examined by the study doctor for any changes to their health
Participate in blood, urine, and other testing. Blood samples will be collected only 3 times during the study.
Complete questionnaires with you about their behavior
Take the study medicine for
8 WEEKS
6 VISITS
(lasting 2-3 hours) over 14-16 weeks
AT HOME
Powder medication, mixed with food
3x daily
Collect urine and stool samples
Answer questions
about your child's behavior
Understanding the Study
The purpose of this study is to learn if the study medication may help improve irritability in 5 to 17-year-old children compared to placebo. AB-2004 was shown to be safe and well tolerated in a previous study involving adolescents with ASD. Eligible participants will be randomly assigned to receive either AB-2004 or placebo.
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ABOUT THE STUDY MEDICATION
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AB-2004 is an experimental therapy that is being developed as a potential treatment for irritability associated with autism.
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Formulated as a powder, the medication is to be mixed with any soft food your child may like such as yogurt or apple sauce.
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It is taken by mouth 3 times per day and is tasteless and odorless.
“The ASD community is in need of safe and effective options for managing anxiety and irritability or distress. AB-2004, with its gut-targeted mechanism of action has the potential to fill this unmet need.”
– Honey Heussler, Associate Professor, Child Health Research Centre, University of Queensland (Australia).
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