22Q Deletion Syndrome Clinical Trial
Official title:
Open-Label, Tolerability and Efficacy Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With 22q11.2 Deletion Syndrome
To evaluate the safety and tolerability of ZYN002 administered as a transdermal gel formulation, for up to 38 weeks, in patients ages 4 to < 18 years, in the treatment of 22q.11.2 Deletion Syndrome (22qDS).
This is an open-label study to assess the safety, tolerability and efficacy of cannabidiol (CBD) administered as ZYN002, a transdermal gel, for the treatment of child and adolescent patients with 22qDS. Male and female patients with 22qDS will be treated in Period 1 for 14 weeks. Patients that meet study criteria will be allowed to continue to Period 2 for an additional 24 weeks of treatment. At the end of study, patients taking antiepileptic drug (AED) medication(s) will have an additional one or two week Taper Period. Approximately 20 male and female patients, ages 4 to < 18 years, will receive ZYN002. ;