Chicago, IL: The administration of a proprietary transdermal CBD gel (aka ZYN002) is safe and effective in patients with Fragile X syndrome (FXS), according to phase 3 clinical trial data published in the Journal of Neurodevelopmental Disorders. FXS is a genetic disorder resulting in developmental delays, learning disabilities, and behavioral problems, such as aggression and attention deficits.
Over 200 pediatric patients (mean age 9.7 years) participated in the 12-week trial. Subjects received either CBD or placebo in addition to their prescribed medications. The study is the largest double-blind, randomized, placebo-controlled clinical trial ever conducted involving FXS patients.
Consistent with prior studies, investigators reported that CBD treatment was effective, safe, and well-tolerated. No serious adverse events were reported.
“In this trial, ZYN002 was well tolerated in patients with FXS and demonstrated evidence of efficacy with a favorable benefit risk relationship,” they concluded. “A confirmatory phase 3, randomized, controlled trial is being conducted in children and adolescent patients with FXS.”
Full text of the study, “A randomized, controlled trial of ZYN002 cannabidiol transdermal gel in children and adolescents with Fragile X Syndrome,” appears in the Journal of Neurodevelopmental Disorders.