Zynerba Pharmaceuticals has commenced the CONNECT-FX trial, a pivotal clinical trial designed to examine the efficacy and safety of ZYN002 to treat patients with Fragile X syndrome (FXS).
The multi-national, randomised, double-blind placebo-controlled clinical study of Cannabidiol (CBD) in Children and Adolescents with Fragile X (CONNECT-FX) aims to enrol around 200 FXS patients aged between three to 17 years.
The trial will enrol the FXS patients, who have the full mutation of the FMR1 gene, at nearly 20 clinical sites in the US, Australia, and New Zealand.
During the trial, the patients will be randomised in 1:1 ratio to receive either ZYN002 or placebo.
The primary endpoint of the CONNECT-FX trial