Patients with Lennox-Gastaut syndrome (LGS) experienced significantly fewer drop seizures with add-on cannabidiol.
A total of 255 participants were randomized 1:1:1 to receive daily cannabidol 20mg/kg (n=76), 10mg/kg (n=73), or placebo (n=76). Eligible participants had a clinical diagnosis of LGS, eight or more drop seizures during a 4-week baseline, and failure of one or more antiepileptic drug. They ranged in age from 2 to 55 years, with a mean age of 16 years (30% were aged 18 or over), and had a median of 85 drop seizures monthly. Participants had failed a median of six and were taking a median of three antiepileptic drugs.
Compared to placebo (17%), participants on cannabidiol experienced a significantly greater reduction in drop seizure frequency: 42% in those taking 20mg/kg (P=0.0047) and 37% in those taking 10kg/mg (P=0.0016).
During the 14-week study period (2-week titration, 12-week dose maintenance), 9 cannabidiol 20mg/kg, 2 cannabidiol 10mg/kg, and 2 placebo participants withdrew early. Mild or moderate adverse events occurred in 94% of the 20mg/kg group, 84% of the 10mg/kg group, and 72% in the placebo group and were mostly somnolence and decreased appetite. Serious treatment-related events occurred in 5 of the 20mg/kg group, 2 of the 10mg/kg group, and in none of the placebo patients. Some elevations in transaminases were seen, but there were no deaths.
Of the 212 participants who completed the study, 99% entered the open-label extension study. According to the press release, participants taking cannabidiol were up to 2.6 times more likely to say their overall condition had improved compared to the placebo group.
“Our results suggest that cannabidiol may be effective for those with Lennox-Gastaut syndrome in treating drop seizures,” said study author Anup Patel, MD (Nationwide Children’s Hospital and The Ohio State University College of Medicine, Columbus, OH). “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 research will be presented during the Clinical Trials plenary session on Tuesday, April 25, 2017.
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). From materials presented at AAN Annual Meeting, Boston, MA. Clinical Trials plenary session. April 25, 2017.