Cannabidiol (8) – Epidyolex®

• Clinical trials
  • This was a randomised, controlled, double-blind trial 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 tuberous sclerosis

• For patients aged 2 years and over with seizures associated with tuberous sclerosis, 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 tuberous sclerosis is not proven.
• In the study 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 with placebo and was therefore continued unchanged.
• The appropriate comparator therapy was therefore not implemented in the study submitted for the benefit assessment.
• Overall review
  • Overall, there are no suitable data available for comparing cannabidiol with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.