Clinical Trial: CBD Gel Mitigates Symptoms in Patients with Fragile X Syndrome


Brisbane, Australia: The administration of a proprietary transdermal CBD gel (aka ZYN002) is safe and effective in patients with fragile X syndrome (FXS), according to clinical trial data published in the Journal of Neurodevelopmental Disorders.

A team of researchers from Australia, Canada, and the United States assessed the use of CBD in 18 patients (aged 6 to 17 years old) diagnosed with FXS. Subjects received twice-daily dosing (between 50 mgs and 250 mgs) of the gel product for 12 weeks.

Subjects experienced "a statistically significant reduction in the mean ADAMS [the Anxiety, Depression, and Mood Scale] total score from screening to week 12." Respondents also showed mean reductions on measurements of hyperactivity, social avoidance, general anxiety, and compulsive behavior.

Authors concluded, "In this open-label study, ZYN002 CBD gel was well tolerated and produced clinically and statistically meaningful reductions in anxiety and behavioral symptoms among children and adolescents with FXS. … Given the lack of medications approved for the treatment of FXS, this open-label study findings highlight the urgent need for randomized, controlled, clinical trials to further assess the safety and efficacy of ZYN002 for FXS symptoms ranging from social avoidance, irritability, social unresponsiveness/lethargy, and stereotypy, to anxiety."

A series of case reports published in May similarly showed a reduction in FSX symptoms in patients treated with CBD. In two of the three cases, symptoms returned after CBD treatment was discontinued, but then improved following the reintroduction of CBD therapy.

For more information, contact Paul Armentano, NORML Deputy Director, at: Full text of the study, "A phase ½, open-label assessment of the safety, tolerability, and efficacy of transdermal cannabidiol (ZYN002) for the treatment of pediatric fragile X syndrome," appears in the Journal of Neurodevelopmental Disorders.