By Amy Orciari Herman
Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, DFASAM
Adjunctive treatment with cannabidiol — a nonhallucinogenic cannabinoid — may reduce seizure frequency in young people with the Dravet syndrome, according to an industry-funded study in the New England Journal of Medicine. The Dravet syndrome is a childhood epilepsy disorder resulting in drug-resistant seizures and high mortality; there currently are no FDA-approved treatments.
Roughly 120 children and young adults aged 2–18 years with the Dravet syndrome and drug-resistant seizures were randomized to receive an oral cannabidiol solution or placebo, in addition to their current antiepileptic regimens, for 14 weeks.
The median number of convulsive seizures per month in the cannabidiol group decreased from 12.4 at baseline to 5.9 at 14 weeks. In contrast, the change in the placebo group was just 14.9 to 14.1. Reductions in nonconvulsive seizures did not differ between the groups.
Adverse events occurred in significantly more cannabidiol than placebo recipients (93% vs. 75%). Side effects associated with active treatment included vomiting, fatigue, fever, somnolence, and elevated liver enzyme levels.1
1. Note that the dosage used was 20 mg/kg.
- METHODS: In this double-blind, placebo-controlled trial, we randomly assigned 120 children and young adults with the Dravet syndrome and drug-resistant seizures to receive either cannabidiol oral solution at a dose of 20 mg per kilogram of body weight per day or placebo, in addition to standard antiepileptic treatment. The primary end point was the change in convulsive-seizure frequency over a 14-week treatment period, as compared with a 4-week baseline period.