Positive Results Published in NEJM for Clinical Trial of Cannabis in Lennox-Gastaut Syndrome
BOHEMIA, N.Y., May 17, 2018 (Newswire.com) - The New England Journal of Medicine has published positive results from a clinical trial of Cannabidiol in Lennox-Gastaut Syndrome.
Cannabidiol (CBD), a compound derived from the cannabis plant that does not produce a “high” has been an increasing focus of medical research in epilepsy. New study results from the clinical trial of Epidiolex® has shown to significantly reduce the number of seizures in patients with Lennox-Gastaut Syndrome.
Lennox-Gastaut Syndrome is a rare and severe form of childhood-onset epilepsy that typically persists into adulthood. Despite currently available medications and a poly-therapy approach to treatment, most individuals with LGS will continue to have life-long, debilitating seizures.
The results of the study, which were published in the New England Journal of Medicine, compared two doses of CBD to placebo. Researchers reported a 41.9% reduction in “drop seizures” for those taking a 20mg/kg/d regimen and a 37.2% reduction in drop seizures in those on a 10 mg/kg/d regimen. Drop seizures are a type of seizure that results in a loss of muscle control and often leads to falls.
Researchers enrolled 225 patients ages 2 to 55 with Lennox-Gastaut syndrome across 30 international sites in a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of cannabidiol in patients. Side effects were reported in 94 of the patients in the 20 mg CBD group, 84 percent in the 10 mg group, and 72 percent of those taking the placebo. Side effects were generally reported as mild or moderate in severity and included sleepiness, decreased appetite, diarrhea, upper respiratory infection, fever, vomiting, nasopharyngitis, and status epilepticus.
Anup Patel, M.D., Chair of the LGS Foundation’s Professional Advisory Board, Chief of Neurology at Nationwide Children’s Hospital, and the study’s co-first author says, “This landmark study provides data and evidence that Epidiolex® can be an effective and safe treatment for seizures seen in patients with Lennox-Gastaut Syndrome.”
Christina SanInocencio, Executive Director of the LGS Foundation says, “LGS is devastating. While it is rare to achieve complete seizure control in this patient population, we sincerely hope that more safe and effective treatment options become available so that patients and their families can have relief from unrelenting seizures.”
For more information on Lennox-Gastaut Syndrome, visit www.lgsfoundation.org.
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Source: LGS Foundation
Categories: Pharmaceuticals and Biotech