BOSTON -- Taking cannabidiol (CBD) may reduce seizures among children and adults with a severe form of epilepsy called Lennox-Gastaut syndrome (LGS), researchers reported from a manufacturer-sponsored trial.
According to a study of more than 200 patients with LGS, nearly 40% had at least a 50% reduction in drop seizures when taking a pharmaceutical-grade liquid form of cannabidiol (Epidiolex), a molecule from the cannabis plant, compared with 15% taking a placebo, reported Anup Patel, MD, of Nationwide Children's Hospital and the Ohio State University College of Medicine in Columbus, and colleagues.
Action Points
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
Additionally, LGS patients who received cannabidiol were up to 2.6 times more likely to report improvement in their overall condition compared with those who received a placebo (66% versus 44%), Patel added.
The study is the second randomized placebo-controlled trial of Epidiolex for LGS with positive effects on drop seizures, and will be presented at the American Academy of Neurology annual meeting.
"Our results suggest that cannabidiol may be effective for those with Lennox-Gastaut syndrome in treating drop seizures," Patel said in a press release. "This is important because this kind of epilepsy is incredibly difficult to treat. While there were more side effects for those taking cannabidiol, they were mostly well-tolerated. I believe that it may become an important new treatment option for these patients."
"This study adds additional support for the efficacy of CBD in LGS drop seizures," noted co-author Orrin Devinsky, MD, of NYU Langone Medical Center in an email to 51˶.
The researchers recruited 225 people with LGS, mean age 16 years, from academic epilepsy centers in the U.S. and Europe. The participants had an average of 85 drop seizures per month, tried an average of six epilepsy drugs that did not work for them, and were taking an average of three epilepsy drugs during the study.
Participants were randomized to receive a higher dose of 20 mg/kg daily cannabidiol, a lower dose of 10 mg/kg daily cannabidiol, or placebo as an add-on to their current medications for 14 weeks.
At the end of the study period, participants who took the higher dose had a 42% reduction in drop seizures overall, and for 40%, their seizures were reduced by half or more. Those who took the lower dose had a 37% reduction in drop seizures overall, and for 36%, seizures were reduced by half or more.
Conversely, those who took the placebo had only a 17% reduction in drop seizures, and for 15%, seizures were reduced by half or more.
The researchers noted that participants who received cannabidiol reported more side effects than those taking placebo, but most were mild to moderate.
"The side effect profile of Epidiolex -- mainly tiredness and decreased appetite -- is better than most of the FDA approved medications, which actually makes it an attractive medication," commented Devinsky.
The researchers concluded that "cannabidiol shows great promise in that it may reduce seizures that are otherwise difficult to control."
Developer GW Pharmaceuticals plans to submit a New Drug Application to the FDA later this year, according to the authors.
Disclosures
The study was supported by GW Pharmaceuticals.
Primary Source
American Academy of Neurology
Patel A, et al "Cannabidiol (CBD) significantly reduces drop seizure frequency in Lennox-Gastaut syndrome (LGS): results of a dose-ranging, multi-center, randomized, double-blind, placebo-controlled trial (GWPCARE3)" AAN 2017.