Cannabidiol Gel for Fragile X Syndrome

Palo Alto (17 mi)

Age: < 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Zynerba Pharmaceuticals, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?ZYN002 is a pharmaceutically manufactured Cannabidiol that is developed as a clear gel that can be applied to the skin (called transdermal delivery). The gel will be applied to clean, dry, intact skin of the shoulders and/or upper arms. Participants from the ZYN2-CL-016 and ZYN2-CL-033 studies who meet the inclusion criteria and none of the exclusion criteria for study ZYN2-CL-017 are eligible. Parents/caregivers will apply the study gel twice daily for the 52-week treatment period.

Eligibility Criteria

This trial is for children and adolescents with Fragile X Syndrome who participated in previous ZYN002 studies. They must follow study rules, provide informed consent through parents/caregivers, and females of childbearing age need a negative pregnancy test. Those with certain ongoing health issues or high liver enzyme levels can't join.

Inclusion Criteria

I am capable of becoming pregnant and have a negative pregnancy test.

Treatment Details

The trial tests the long-term safety of ZYN002, a Cannabidiol Transdermal Gel applied to the skin for those with Fragile X Syndrome. Participants will use this gel twice daily for one year to see how well they tolerate it over time.

1Treatment groups

Experimental Treatment

Group I: ZYN002Experimental Treatment1 Intervention

ZYN002 - cannabidiol Transdermal Gel