
Quality of life
Overall condition was assessed at baseline and last visit on the seven-category Patient or Caregiver Global Impression of Change (GIC) scale. The patient’s overall condition improved by at least one category on the seven-category GIC scale. Improvements were based on measures of GIC scores at the last visit.
Lennox-Gastaut syndrome (LGS)
Significantly more LGS patients and caregivers reported improvements on the GIC scale with Epidyolex and clobazam (CLB) than with placebo.1
p<0.0001 & p=0.0003
p=0.0005
Dravet syndrome (DS)
Significantly more DS caregivers reported improvements on the GIC scale with Epidyolex and clobazam than with placebo.1
p=0.0018 and 0.0136
p=0.0009
The post-hoc analysis has been prepared at the request of the CHMP, p-values for this analysis were found to be nominal.
Significantly more LGS and DS patients and caregivers reported improvements on the GIC scale with Epidyolex and clobazam than placebo.1
References
1. Epidyolex Summary of Product Characteristics (Date accessed: 03/09/2020).