The SCOT Trial: Our Ongoing Pediatric Clinical Trial
Initiated in December 2016, the SCOT trial is designed to meet US FDA regulations for Good Clinical Practices. The SCOT trial is being executed under an approved US IND 125274. The double blind, randomized, placebo controlled trial consists of approximately 66 SCD patients between the ages of 5 and 17 years old. Performed in preeminent sickle cell medical centers throughout the United States, enrollment commenced in March of 2017 and was completed in record time by July, 2017. The study is designed to confirm a rapid uptake of certain fatty acids into red blood cells depleted as a result of the disease. The study will measure replenishment of cell membranes as the primary endpoint as well as reduction or elimination of anemia and red cell destruction in patients. It will also measure the level of inflammation, and clotting factors linked to Vaso-occlusive crisis (VOCs). VOCs will be reported for all patients in the study along with any adverse events. Patients enrolled in the study will be eligible to continue on medication in an open label extension of the trial expected to end in a year following initial dosing.
For additional information on this clinical trial, please click here