Results Between Jan 15, 2014, and Jan 15, 2015, 214 patients were enrolled; 162 patients who had at least 12 weeks of follow-up after the first dose of cannabidiol were included in the safety and tolerability analysis, and 137 patients were included in the efficacy analysis.
In the safety group, 33 patients had Dravet syndrome and 31 patients had Lennox-Gastaut syndrome.
The remaining patients had intractable epilepsies of different causes and type.
Adverse events were reported in 128 of the 162 patients within the safety group.
Five patients discontinued treatment because of an adverse event.
Serious adverse events were reported in 48 patients, including one death-a sudden unexpected death in epilepsy regarded as unrelated to study drug.
20 patients had severe adverse events possibly related to cannabidiol use, the most common of which was status epilepticus.Devinsky-CBD-LANCET-NEURO-2015