In children with Dravet syndrome, short-term exposure to purified cannabidiol (CBD) is safe and well tolerated overall, despite being associated with a greater number of adverse effects than placebo, according to a randomized trial published in Neurology.
Investigators randomly assigned pediatric patients (age 4-10 years) to receive either twice-daily 5, 10, or 20 mg/kg/day CBD (n=27) or placebo (n=7). The double-blind phase of the study consisted of a 4-week baseline period, 3-week treatment period, 10-day taper, and 4-week follow-up. The 32 patients who completed treatment were invited to continue in the open-label extension study.
On the first day of dosing and at the end of treatment, investigators obtained pharmacokinetic blood samples to measure CBD levels as well as levels of antiepileptic drugs. Investigators also assessed safety outcomes using clinical laboratory tests, physical examinations, vital signs, and electrocardiograms.
Exposure to both CBD and its metabolites (ie, 6-OH-CBD, 7-OH-CBD, and 7-COOH-CBD) was