Title
Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm
Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm - a Prospective Double-masked Cross-over Study
Phase
Phase 2/Phase 3Lead Sponsor
Silkiss Eye SurgeryStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
CBD Blepharospasm Blepharospasm, Benign EssentialIntervention/Treatment
Cannabidiol Oral Solution [Epidiolex]Study Participants
12The 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.
100 mg BID for three months Placebo oral solution for three months
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.
