The study findings add evidence to support cannabidiolâ€™s effectiveness in reducing severe seizures in this patient population.
Cannabidiol (CBD) significantly reduces seizure burden in a severe form of epilepsy, known as Lennox-Gastaut syndrome (LGS), according to a recently-published study in The New England Journal of Medicine.
Although there are currently 6 medications approved to treat seizures in patients with LGS, the researchers indicated that disabling seizures often occur even with treatment.
In the study, the researchers evaluated the effect of an investigational liquid, oral formulation of CBD called Epidiolex, in patients with LGS. The researchers enrolled 225 patients aged 2 to 25 years across 30 international sites to assess the efficacy and safety of 2 doses of CBD.
Seventy-six of the patients received 20 mg/kg/d CBD, 73 received 10 mg/kg/d CBD, and 76 were given a placebo. Each patient received 2 doses per day over a 14-week period. The researchers monitored seizures 4 weeks prior to treatment for baseline assessment. Seizures were then tracked during the study period and afterwards for a 4-week safety check.
Overall, the researchers reported a 41.9% reduction in “drop seizures,” a type of seizure that results in severe loss of muscle control and balance, in patients taking a 20 mg/kg/d CBD regimen. Seizures were reduced by 37.2% in patients taking a 10 mg/kg/d CBD regimen and 17.2% in patients who were given a placebo.
“This new study adds rigorous evidence of cannabidiol’s effectiveness in reducing seizure burden in a severe form of epilepsy, and, importantly, is the first study of its kind to offer more information on proper dosing,” Orrin Devinsky, MD, a professor of neurology, neurosurgery, and psychiatry at NYU School of Medicine and director of NYU Langone’s Comprehensive Epilepsy Center, said in a press release.
Adverse effects reported throughout the study were generally mild or moderate in severity, with the most common occurring in more than 10% of patients. These included sleepiness, decreased appetite, diarrhea, upper respiratory infection, fever, vomiting, nasopharyngitis, and status epilepticus.
Additionally, 14 patients taking CBD experienced dose-related, elevated liver enzymes that were reversible and 7 patients withdrew from the trial due to adverse effects.
In April 2018, an FDA committee unanimously recommended the approval of Epidolex for the treatment of seizures associated with LGS and Dravet syndrome.
“While the news gives hope for a new treatment option to the epilepsy community, more research remains imperative to better determine the effects of CBD and other similar cannabis-derived compounds on other forms of the disease and in more dosing regimens,” Dr Devinsky concluded.
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Devinsky O, Patel AD, Cross JH, et al. Effect of cannabidiol on drop seizures in the Lennox- Gastaut syndrome. New England Journal of Medicine. 2018. Doi: 10.1056/NEJMoa1714631
Cannabidiol Significantly Reduces Seizures in Patients with Severe Form of Epilepsy [news release]. NYU’s website. https://nyulangone.org/press-releases/cannabidiol-significantly-reduces-seizures-in-patients-with-severe-form-of-epilepsy. Accessed May 17, 2018.