Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm
Status:
Completed
Trial end date:
2021-10-01
Target enrollment:
Participant gender:
Summary
The planned study is a prospective analysis of non-psychoactive Cannabidiol (without THC) as
an adjunctive therapy for blepharospasm in a masked double cross-over study. This prospective
study is a follow-up to a retrospective study completed by the researchers using
over-the-counter, self purchased CBD. This study will use FDA approved Cannabidiol
medication, Epidiolex, directly from GW pharmaceuticals, rather than self-purchased CBD from
the internet. Patients will undergo videorecording with a high resolution videocamera system
at days 0, 45, 90, 135, and 180 using a novel blink analysis to gather objective data
measurements of changes induced by CBD in Blepharospasm patients. This study will attempt to
codify the data and quantify if adjunctive CBD therapy improves those areas compared to
botulinum injection alone.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Silkiss Eye Surgery
Collaborators:
Benign Essential Blepharospasm Research Foundation GW Pharmaceuticals Ltd. Smith-Kettlewell Eye Research Institute