NCT04423341

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Silkiss Eye Surgery · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Blepharospasm
• Blepharospasm, Benign Essential
• CBD

Interventions

Type	Name	Description
DRUG	Cannabidiol Oral Solution [Epidiolex]	100 mg BID for three months Placebo oral solution for three months

Timeline

• Start date: 2020-05-20
• Primary completion: 2021-03-22
• Completion: 2021-10-01
• First posted: 2020-06-09
• Last updated: 2021-11-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study