Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm

• Status: Completed
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Silkiss Eye Surgery
• Collaborators: Benign Essential Blepharospasm Research Foundation; GW Pharmaceuticals Ltd.; Smith-Kettlewell Eye Research Institute
• Treatments: Cannabidiol; Epidiolex

Criteria

Inclusion Criteria:

• Patients in the private practice of the principal investigator with an ICD code of "blepharospasm" and:

• undergoing routine maximal botulinum therapy

• experiencing break through symptoms of spasm

• marijuana naïve

Exclusion Criteria:

• concomitant diagnosis of epilepsy

• patients whom are not marijuana naive

• patients on concurrent anti-epileptics

• patients who are pregnant or wishing to become pregnant

• patients not wishing to participate in the study.