Cannabidiol (7) – Epidyolex®

• Clinical trials
  • To assess the additional benefit, the pharmaceutical manufacturer has submitted analyses of studies GWEP1414 and GWEP1423.
  • These are two randomised, controlled, double-blind studies in which cannabidiol was compared with placebo, in each case in addition to ongoing anti-epileptic treatment.

Patients aged 2 years and over with seizures associated with Lennox-Gastaut syndrome

• For patients aged 2 years and over with seizures associated with Lennox-Gastaut syndrome, the additional benefit is not proven.
• The additional benefit of cannabidiol compared with the appropriate comparator therapy for patients aged 2 years and over with seizures associated with Lennox-Gastaut syndrome is therefore not proven.
• In the studies relevant to this benefit assessment, no optimisation of antiepileptic treatment was planned for patients in the comparator arm.
• Although the included patients experienced regular epileptic seizures, the existing anti-epileptic medication in the comparator arm was supplemented only by placebo and was therefore continued unchanged.
• The appropriate comparator therapy was therefore not implemented in the studies submitted for the benefit assessment.
• Overall review
  • In the overall review, there are no suitable data available for comparing cannabidiol with the appropriate comparator therapy. Consequently, additional benefit from cannabidiol is not proven for patients aged 2 years and over with seizures associated with Lennox-Gastaut syndrome.

Courtesy translation only, please refer to the German original.