An independent analytical laboratory will also perform CGG repeat and methylation status analyses.
#Imail mssm edu skin
The gel will be applied to clean, dry, intact skin of the upper arms/ shoulders.īlood samples will be collected for safety analysis of ZYN002. Parents/ caregivers will be instructed on proper application of the gel. Participants who weigh more than 50 kg will receive 6 sachets of gel per day (3 sachets approximately every 12 hours). If the participant weighs more than 30 kg but less than or equal to 50 kg, they will receive 4 sachets of gel per day (2 sachets approximately every 12 hours). If the participants weigh less than or equal to 30 kg, they will receive 2 sachets of the gel per day (1 sachet approximately every 12 hours). The dose of the treatment will depend on the weight of the participants. The assignment of study drug or placebo will be done by a computer generated system and neither the study doctor, participant or their caregivers will know which treatment is being given to them. The study will be comprised of a Screening visit and a combination of seven visits both onsite (face-to-face) and virtual. Randomization will be stratified by gender, methylation status and weight. 204 male and female patients, ages 3 to < 18 years, will be randomized 1:1 to either trial drug or placebo and will undergo a 18-week treatment period. This is a randomized, double-blind, placebo-controlled, multiple-center study, to assess the efficacy and safety of ZYN002, a pharmaceutically manufactured cannabidiol, formulated as a clear gel that can be applied to the skin (called transdermal delivery), in children and adolescents with FXS. Why Should I Register and Submit Results?.
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