Fragile X Reconnect Study

Study Overview

• Study Director: Elysa Marco, MD 

• Recruiting: Yes 

• Study Title: A randomized, double-blind, placebo-controlled, multiple-center, efficacy and safety study of ZYN002 administered as a transdermal gel to children, adolescents, and young adults with Fragile X Syndrome 

• Condition: Fragile X Syndrome 

• Purpose: The purpose of this study is to find out whether an investigational transdermal CBD gel can affect sociability and behavioral symptoms in individuals with Fragile X Syndrome. 

Eligibility 

Inclusion criteria: 

• 3-29 years old 

• Diagnosed Fragile X Syndrome with full FMR1 mutation 

• Stable medications, therapies, and diet prior to screening visit 

• A designated caregiver who provides consistent care throughout the study 

Exclusion criteria: 

• Seizures requiring current management with over 3 medications 

• Use of THC or CBD-containing products within 3 months of screening visit 

• Certain skin diseases or conditions 

• Medications that interact with this study medication – contact our study team to discuss