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Design: Multinational double-blinded placebo-controlled trial. Patients randomised in 1:1 ratio to receive cannabidiol or placebo, in addition to stable antiepileptic treatment regime.
Setting: Twenty-three centres in Europe and USA.
Patients: Patients aged 2 years to 18 years with established diagnosis of Dravet syndrome having at least four convulsive seizures during the 28-day baseline period despite regular antiepileptic medication.
Intervention: Adjunctive cannabidiol or placebo oral solution at 20 mg per kilogram of body weight per day.
Primary outcome: Percentage change in median frequency of convulsive seizures per month.
Follow-up period: Outcome measured over a 14-week treatment period in comparison to a 4-week baseline period.
Patient follow-up: One hundred and eight (90%) completed the trial: 85% (52/61) in the cannabidiol group and …
Competing interests None declared.
Provenance and peer review Not commissioned; internally peer reviewed.