The 14-week study, known as BRIGHT, has enrolled 36 pediatric and adolescent patients with autism spectrum disorder (ASD) in Australia. The goal is to evaluate the efficacy and safety of Zygel in patients with autism, using measurements such as the Aberrant Behavior Checklist, the Parent Rated Anxiety Scale, Autism Impact Measure and others.
“We are committed to developing new treatment options to improve outcomes in patients suffering from a variety of neuropsychiatric conditions including autism spectrum disorder, and achieving our enrollment target in the BRIGHT trial is an especially meaningful step toward this goal,” Chief Medical Officer Joseph Palumbo said in a statement.
“We would like to thank everyone involved in this study to date, particularly the participating patients and their caregivers, as well as the investigators. We look forward to announcing topline results from this study in the second quarter of 2020.”
According to the Autism Diagnostic Observation Schedule, 94% of the enrolled patients showed moderate-to-severe symptoms of ASD at a baseline level. The mean age of the patients is 9.3 years, the company said, and 92% are male.
Zygel is the only pharmaceutically-manufactured CBD formulated as a clear gel, the company said, which is designed to provide controlled drug delivery through the skin. Some recent studies have suggested that neuropsychiatric conditions like ASD or Fragile X Syndrome are associated with a disruption in the endocannabinoid system, and CBD may improve certain core social and behavioral autism-related symptoms by modulating that system.
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