Clasepi

N Engl J Med. 2018 May 17;378(20)

Trial & study design: Double-blind, placebo-controlled trial

Sample size: N= 225

Dosage and duration: Placebo (N=76), 10-mg/kg/day Cannabidiol (N=73), 20-mg/kg/day Cannabidiol (N=76) for 14 weeks.

Results:

• The median percent reduction from baseline in drop-seizure frequency during the treatment period was 41.9% in the 20-mg cannabidiol group, 37.2% in the 10-mg cannabidiol group, and 17.2% in the placebo group (P=0.005 for the 20-mg cannabidiol group vs. placebo group, and P=0.002 for the 10-mg cannabidiol group vs. placebo group).

Safety and side effects-

• The most common adverse events among the patients in the cannabidiol groups were somnolence, decreased appetite, and diarrhea; these events occurred more frequently in the higher-dose group.
• Fourteen patients who received cannabidiol (9%) had elevated liver aminotransferase concentrations.

Conclusion:

• Among children and adults with the Lennox–Gastaut syndrome, the addition of cannabidiol at a dose of 10 mg or 20 mg per kilogram per day to a conventional antiepileptic regimen resulted in greater reductions in the frequency of drop seizures than placebo.