Multi-Center Trial Coordination


Cannabidiol Trails image

The state of Georgia, along with GW Pharmaceuticals, and officials at Augusta University have been working together to study pharmaceutical grade cannabidiol (Epidiolex®) (CBD) (make Epidiolex a hyperlink to cannabidiol site - http://www.augusta.edu/research-1/about/cannabidiol/index.php) – a specific part of the marijuana plant – to see if the drug has the potential to improve the quality of life for young patients with severe epilepsy. SVP Research manages and oversees this special project and serves as the coordinating center.

GW Pharmaceuticals is a world leader in the development of prescription cannabinoid medicines, and conducts scientific research in accordance with U.S. federal law with permission from the U.S. Food & Drug Administration and the U.S. Drug Enforcement Administration. The FDA has already authorized physician-sponsored Investigational New Drug programs with Epidiolex at 12 sites around the U.S involving over 300 children. In parallel, GW is progressing a company-sponsored formal development program for Epidiolex that is focused on the treatment of two rare and severe forms of childhood epilepsy, Dravet syndrome and Lennox-Gastaut syndrome.

The New England Journal of Medicine published an article in May 2017 of a double blind, placebo-controlled study of 120 children and young adults with epilepsy who received GW’s CBD product. The study results have proved promising and have spurred additional CBD studies in epileptic children.

Analyses of Data from Twenty-Seven Patients Showed:

  • The median frequency of convulsive seizures per month decreased from 12.4 to 5.9 with cannabidiol, as compared with a decrease from 14.9 to 14.1 with placebo (adjusted median difference between the cannabidiol group and the placebo group in change in seizure frequency, −22.8 percentage points; 95% confidence interval [CI], −41.1 to −5.4; P=0.01).
  • The percentage of patients who had at least a 50% reduction in convulsive-seizure frequency was 43% with cannabidiol and 27% with placebo (odds ratio, 2.00; 95% CI, 0.93 to 4.30; P=0.08).
  • The patient’s overall condition improved by at least one category on the seven-category Caregiver Global Impression of Change scale in 62% of the cannabidiol group as compared with 34% of the placebo group (P=0.02).
  • The frequency of total seizures of all types was significantly reduced with cannabidiol (P=0.03), but there was no significant reduction in non-convulsive seizures.
  • The percentage of patients who became seizure-free was 5% with cannabidiol and 0% with placebo (P=0.08).  As of May 2017, State of Georgia CBD Study has enrolled 53 patients, between the ages 1 and 18 years old, with 47 patients receiving at least one year of treatment with CBD.

As of May 2017, the State of Georgia CBD Study has enrolled 53 patients, between the ages 1 and 18 years old, with 47 patients receiving at least one year of treatment with CBD.  

Georgia Cannabidiol Trials