The Tapestry Autism Study
The University of Arizona Division of Developmental & Behavioral Pediatrics has partnered with Axial Therapeutics for a clinical trial to determine whether its investigational drug, AB-2004, is safe and effective in treating the symptoms of autism spectrum disorder in children ages 5-17. This 12-week randomized, double-blind, placebo-controlled study includes behavioral assessments and safety monitoring. Blood draws, urine and stool samples are required.
Study phase: II
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
* 5-17 years old
* Diagnosed with Autism Spectrum Disorder
* Highly irritable
* Is able to attend clinic appointments in person
* Has a parent or caregiver who can read, write and speak English to complete study assessments
Additional information:
Current use of controlled-release, extended-release, or antipsychotic medications is prohibited. Switching to an immediate-release and/or non-antipsychotic medication would be required to participate in the trial.
Primary disease category: Child Development & Autism
Secondary disease categories: Children, Infants & Newborns
Sponsor: Axial Therapeutics
Protocol number: AXL-2004-002
Projected enrollment dates: August 2021 to August 2023
Official study title: Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of AB-2004 in an Autism Spectrum Disorder Population
External link(s):
https://www.theautismstudy.com/
ClinicalTrials.gov page:
http://www.clinicaltrials.gov/show/NCT04895215