This study is testing a special gel called ZYN002 made from cannabidiol (CBD), which comes from the cannabis plant. The gel is being tested to see if it helps kids, teens, and young adults who have Fragile X Syndrome (FXS), a genetic condition causing learning and behavioral challenges. The study lasts for up to 18 weeks and includes 250 participants aged 3 to less than 30 years. Participants are randomly given either the CBD gel or a placebo (a fake medicine) without knowing which one they receive. The gel is applied to the skin and the amount depends on the person’s weight.
- Duration: The study lasts up to 18 weeks, with a mix of in-person and virtual visits.
- Participation: Requires multiple visits and applying gel to the skin regularly.
- Eligibility: For ages 3 to less than 30, must live with a caregiver, and have a confirmed FXS diagnosis.
Participants need to be generally healthy and not use certain medications or substances like cannabis. Regular check-ups and blood tests ensure safety, and the effects are monitored through questionnaires filled out by caregivers and doctors.