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Highly purified cannabidiol (CBD) at a dose of 10mg/kg/day can reduce convulsive seizures in children with Dravet syndrome by almost 50%, a study published in
Neurology
has found.
Dravet syndrome is a rare, severe form of childhood epilepsy and current medicines are unable to provide complete seizure control.
The study investigated 199 patients with Dravet syndrome who were already taking a median of three anti-epileptic drugs. The patients, who had a mean age of 9 years, were randomized to receive either highly purified CBD at 20mg/kg/day (CBD20), highly purified CBD at 10mg/kg/day (CBD10) or placebo.
The researchers then examined the change in convulsive seizure frequency over a 14-week treatment period by comparing it to the 4 weeks before treatment.
They found that in the group taking CBD20, the number of convulsive seizures was reduced by 46%, while in the CBD10 group the number of seizures was reduced by 49%. In the placebo group, the number of seizures reduced by 27%.
For the CBD20 group, 49% of the children achieved a ≥50% reduction in the number of convulsive seizures, compared with 44% of children in the CBD10 group and 26% of children in the placebo group.
“It’s exciting to be able to offer another alternative for children with this debilitating form of epilepsy, and their families,” said study author Ian Miller, a neurologist at Nicklaus Children’s Hospital in Florida.
“The children in this study had already tried an average of four epilepsy drugs with no success, and [when the study was conducted] were taking an average of three additional drugs, so to have this measure of success with cannabidiol is a major victory.”
The incidence of adverse events, including decreased appetite and fatigue, was similar across all groups, at 90% for CBD20, 88% for CBD10 and 89% for placebo.
However, discontinuations owing to adverse events only occurred in the CBD20 group.
The authors, who will present the results at the American Academy of Neurology’s 71st Annual Meeting in Philadelphia (4–10 May 2019), concluded that both CBD20 and CBD10 significantly reduced seizure frequency but that dose increases of around 10mg/kg/day should be tailored to individual efficacy and safety.
