Fragile X Syndrome Research Study
Currently enrolling children and adolescents ages 3 to 17 years of age with Fragile X syndrome who are also experiencing behavioral-related issues.
Why is this Medical Research Study Important?
The purpose of this study is to assess the efficacy and safety of cannabidiol (CBD) administered as a transdermal gel (ZYN002) for the treatment of children and adolescent participants with Fragile X syndrome (FXS).
Children and adolescents with FXS often experience behavioral symptoms such as anxiety (such as social anxiety/avoidance, irritability, tantrums and social unresponsiveness, which can be challenging, not only for the participants, but also their families. ZYN002 may help to reduce these symptoms and has shown promising results in prior studies.
To help us learn more about the safety and efficacy of ZYN002, volunteers are needed for the RECONNECT study. Qualified participants will receive study drug or placebo and will help researchers learn if ZYN002 can help.
Qualified Participants Must:
Be between the ages of 3 and 17 years of age.
Have a diagnosis of FXS; with full mutation of the FMR1 gene documented through genetic testing.
Be experiencing behavioral symptoms of Fragile X syndrome such as social anxiety/avoidance, irritability and social unresponsiveness.