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AB-2004 in Treatment of Adolescents With Irritability Associated With Autism Spectrum Disorder

May 20, 2021 - June 30, 2023

Research has shown that certain bacteria in the gut produce substances that may enter the bloodstream and reach the brain, which my contribute to some characteristics often co-occurring with autism, such as irritability. Reducing these substances in the gut before they enter the bloodstream is a potential new approach to treating irritability associated with ASD. AB-2004, with its gut-targeted mechanism of action has the potential to fill this unmet need.

What are the goals of the study?

The study medication AB-2004 is designed to adsorb specific substances produced by bacteria in the gut and reduce their levels circulation in the bloodstream. The purpose of this study is to learn if AB-2004 may help improve irritability in adolescents compared to placebo by lowering the levels of these substances. The study seeks to determine if there is an effective dose of AB-2004 in 13 to 17 year olds with ASD.

What will happen during the visit or online?

Participants will be examined by the study doctor for any changes to their health, complete a behavioral questionnaire, and participate in blood, urine, and other testing. Blood samples will be collected only 3 times during the study. Participants will take the study medication for 8 weeks and attend 6 clinic visits (lasting 2-3 hours) over 14-16 weeks. Formulated as a tasteless odorless powder, the medication is to be taken 3x/day mixed with any soft food your child may like such as yogurt or apple sauce. You will also be asked to collect urine and stool samples.

How will this help families?

Physicians have reported that irritability impacts a majority of pediatric ASD patients. The presentation of ASD-associated irritability can very with autism severity and age and can be caused by a broad array of different factors including lack of sleep, the inability to communicate pain, and mental health conditions. Currently, there are limited treatment options available for irritability associated with ASD and those that are approved can have significant side effects. AB-2004 offers potential hope of a new therapeutic option for autism-related irritability that might improve patients’ daily lives by avoiding the side effects and risks of currently available medications for irritability of autism.

Eligibility Criteria
  • Male or female
  • Ages 13-17
  • Highly irritable
  • Able to attend in person clinic visits
  • Clinically diagnosed, documented ASD (Diagnostic and Statistical Manual of Mental Disorders [DSM-5] criteria)
  • Aberrant Behavior Checklist – Irritability (ABC-I) score ≥18 at the screening visit
  • Clinical Global Impression – Severity (CGI-S) scale score ≥4 at the screening visit

View the study flyer here.

Watch an informational video here.

See this study on ClinicalTrials.gov

Contact Information

Visit The Autism Study to check eligibility and register your interest

 

Research Study Website
The Autism Study: TAPESTRY Study Clinical Trial

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