For some children with severe epilepsy, traditional treatments and medications are failing to keep their multiple, debilitating seizures under control. But clinical researchers at Augusta University are studying pharmaceutical grade cannibidiol – a specific part of the marijuana plant – to see if the drug has the potential to improve the quality of life for these young patients.
Two clinical trials have been approved at Augusta University. A two-person compassionate use protocol that received authorization from both the Drug Enforcement Agency and the U.S. Food and Drug Administration began in December at Children’s Hospital of Georgia. Patients are being enrolled at CHOG and at study partner sites in Atlanta and Savannah for an expanded 50-person trial.
The state of Georgia, along with GW Pharmaceuticals, and officials at Augusta University have been working together since May to begin a study with GW’s investigational cannabidiol (CBD) product Epidiolex®, which has promising data for difficult to treat childhood epilepsies.
Georgia Governor Nathan Deal announced in April his support for clinical research that would investigate the use of CBD, a non-psychoactive component of the cannabis (marijuana) plant, and develop rigorous data that will inform and expand the scientific community’s understanding of potential treatments.
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 Epidiolex studies are open for enrollment. For more details about recruiting locations, please call 706-721-3371.
Neurologist Dr. Yong Park, Director of the Pediatric Epilepsy Program at Children’s Hospital of Georgia and Professor of Neurology and Pediatrics at Augusta University’s Medical College of Georgia, is the principal investigator on the Epidiolex clinical trials.
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