A pharmaceutical formulation of cannabidiol significantly reduced the number of seizures experienced by children with Dravet syndrome, according to study findings being presented at the American Academy of Neurology Annual Meeting.
“It’s exciting to be able to offer another alternative for children with this debilitating form of epilepsy and the family,” Ian Miller, MD, of Nicklaus Children’s Hospital, said in a press release. “The children in this study had already tried an average of four epilepsy drugs with no success and at the time were taking an average of three additional drugs, so to have this measure of success with cannabidiol is a major victory.”
Researchers divided participants into three groups that either received placebo, 20 mg/kg cannabidiol per day or 10 mg/kg cannabidiol per day for 14 weeks. Seizures were recorded for 4 weeks prior to the start of treatment to serve as a baseline.
The study included 199 children (average age, 9 years). At the end of the study, seizures with convulsions decreased by 46% in children taking 20 mg/kg of cannabidiol, 49% in those taking the 10mg/kg dose and 27% in those who received placebo. The number of seizures decreased by 47% in those taking 20 mg/kg, 56% in those taking 10 kg/mg and 30% in those in the placebo group.
A pharmaceutical formulation of cannabidiol significantly reduced the number of seizures experienced by children with Dravet syndrome.
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All groups reported adverse effects, including decreased appetite, diarrhea, sleepiness, fever and fatigue while taking cannabidiol. Adverse effects were reported in 90% of children taking 20 mg/kg per day, 88% of those taking 10 mg/kg per day and in 89% of those taking placebo.
Serious adverse effects occurred in 25% of children the high dose group, 20% of the low dose group and 15% of the placebo group, and 7% of children in the high dose group stopped taking cannabidiol due to side effects.
“Based on results, dose increases above 10 mg/kg per day should be carefully considered based on the effectiveness and safety for each individual,” Miller said. – by Erin Michael
Miller, et al. Cannabidiol significantly reduces convulsive seizure frequency in children and adolescents with Dravet syndrome: Results of a dose-ranging, multi-center, randomized, double-blind, placebo-controlled trial (GWPCARE2). Presented at: The American Academy of Neurology’s Annual Meeting; May 4-10, 2019; Philadelphia.
Disclosures: The study was supported by GW Research Ltd. Miller has received personal compensation for consulting, servicing on a scientific advisory board, speaking, or other activities with DS Foundation, GWPharma, Insys pharmaceuticals, Neuroblate, TS Alliance, Ultragenix, Visualase and Zogenix. See the full study for all other authors’ relevant disclosures.