Department of Pediatrics, School of Medicine
Medical Director, MIND Institute
Zynerba CONNECT-016; and
Open Label Extension study of Assess long Term safety and Tolerability of ZYN002 administered as a Transdermal Gel in Children and Adolescents with Fragile X Syndrome CONNECT-FX-OLE
A controlled trial of ZYN002 which is a CBD ointment made by Zynerba and it is rubbed into the skin at the shoulder twice a day in Children (3 to 18 yo) with Fragile X Syndrome (FXS). Each packet contains 125 mg and the dose is by weight of the child. This study lasts 12 weeks and the outcome measures include the Aberrant Behavioral Checklist FX-version, the ADAMS, the CGI-s and the CGI-I, a pediatric quality of life measure and the Tobii Eye tracker paradigm assessing eye contact. The main target is improvement of anxiety but other behaviors are also assessed.
Once this study is completed they can roll over into the Zynerba CONNECT-FX-OLE which lasts a year and visits are at 1, 3, 6, 9 and 12 months with basically the same outcome measures.
Since these studies are not completed yet we have not published on these but I have published on case studies of CBD in FXS, which you can view below.