At a glance
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A Randomized, Double-Blind, Placebo-Controlled Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With Fragile X Syndrome
In Brief
A Phase 3 clinical trial evaluating ZYN002 - Cannabidiol Transdermal Gel and Placebo Transdermal Gel for Fragile X Syndrome. Completed, enrolled 212 participants across 21 sites in 3 countries.
Detailed Summary
This trial will evaluate the efficacy and safety of ZYN002, a clear cannabidiol gel that can be applied to the skin (called transdermal application) twice a day for the treatment of behavioral symptoms of Fragile X Syndrome (FXS). Eligible participants will then participate in up to a 14 week treatment period, where all participants will receive placebo or active study drug. Patients ages 3 to \< 18 years, will be eligible to participate.
Study Details
Timeline
Interventions
Pharmaceutically manufactured. Cannabidiol formulated as a clear gel (transdermal delivery)
Placebo formulated as a clear gel (transdermal delivery)