MedicalResearch.com Interview with:
MedicalResearch.com: What is the background for this study?
Response: The study evaluated kids and adults with an epilepsy syndrome (Lennox Gastaut Syndrome – LGS) that is often difficult to treat and does not respond well to current medical treatment. The study was a double blind randomized control trial evaluating how well a plant based, liquid solution, cannabidiol (CBD) product made by Greenwich Biosciences called Epidiolex helped to treat drop seizures (the most common seizure type in LGS) and how safe it was compared to placebo. Two doses (10 mg/kg/day and 20 mg/kg/day) were evaluated compared to placebo.
MedicalResearch.com: What are the main findings?
Response: Overall, the medication was well tolerated and showed a decrease in drop seizures compared to placebo. Both doses showed benefit in seizure reduction compared to placebo. There was a 41.9% median seizure reduction for 20 mg/kg/d cannabidiol and 37.2% median seizure reduction for 10 mg/kg/d. The most common side effects reported were somnolence, decreased appetite, diarrhea, upper respiratory tract infection, pyrexia, and vomiting.
MedicalResearch.com: What should readers take away from your report?
Response: The data suggests that Epidiolex is well tolerated and can decrease drop seizures seen in patients with LGS compared to placebo. This is the gold standard method of evaluating if a treatment is effective and safe for use in diseases. This is the first plant based marijuana derived product to be studied in this fashion for patients who have this type of epilepsy.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: We hope that this study helps lead to the eventual approval by the FDA for use in patients who have seizures seen in Lennox Gastaut Syndrome.
MedicalResearch.com: Is there anything else you would like to add?
Response: The study was a multicenter study in the USA and Europe. I am proud of our research center at Nationwide Children’s Hospital as we enrolled more patients into this study than any other site in the world.
The study was sponsored by Greenwich Biosciences. I did not receive any personal funds for this study. I have providing consulting on unrelated work to this study from Greenwich Biosciences.
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