Dose-ranging effect of adjunctive oral cannabidiol vs placebo on convulsive seizure frequency in Dravet syndrome: A randomized clinical trial
JAMA Mar 12, 2020
Miller I, Scheffer IE, Gunning B, et al. - A randomized clinical trial was designed to assess the efficacy and safety of a pharmaceutical formulation of cannabidiol, 10 and 20 mg/kg/d, vs placebo for adjunctive treatment of convulsive seizures in patients with Dravet syndrome. Researchers conducted a double-blind, placebo-controlled, randomized clinical trial (GWPCARE2) recruiting individuals between April 13, 2015, and November 10, 2017, with follow-up completed on April 9, 2018. The primary endpoint included change from baseline in convulsive seizure frequency during the treatment period. Change in all seizure frequency, the proportion with at least a 50% reduction in convulsive seizure activity, and change in Caregiver Global Impression of Change score were considered as secondary outcomes. The results of this study indicated that adjunctive cannabidiol at doses of 10 and 20 mg/kg/d led to similar clinically relevant reductions in convulsive seizure frequency with a better safety and tolerability profile for the 10-mg/kg/d dose in children with treatment-resistant Dravet syndrome. It was noted that dose increases of cannabidiol to greater than 10 mg/kg/d should be tailored to individual efficacy and safety.
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