Insys Therapeutics’ Phase 2 trial to evaluate the safety and effectiveness of its cannabidiol (CBD) oral solution in pediatric patients with Prader-Willi syndrome (PWS) will soon begin recruiting participants.
More information about the study and dates of enrollment will be announced on the clinical trial’s official webpage, found here (NCT02844933).
The Insys announcement also recognizes May as PWS Awareness Month.
The trial expects to enroll 66 children and teens, ages 8 to 17, at 10 clinical sites in the United States. Patients will be randomized to receive either the CBD oral solution (delivered as 40 mg/kg per day, divided into two daily doses) or a matching placebo control.
The trial’s primary objective (endpoint) is to determine the therapy’s impact on patients hyperphagia — an insatiable appetite that characterizes Prader-Willi syndrome and is linked to obesity, type 2 diabetes, and premature death.
Researchers will measure patient outcomes as changes from the start