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

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm - a Prospective Double-masked Cross-over Study

Conditions
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CBD, Blepharospasm, Blepharospasm, Benign Essential

Intervention / Treatment
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* Drug: Cannabidiol Oral Solution [Epidiolex]


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A - active medication followed by placebo<br> | Drug: Cannabidiol Oral Solution [Epidiolex]<br>* 100 mg BID for three months Placebo oral solution for three months<br>|
| Active Comparator: Group B - placebo followed by active medication<br> | Drug: Cannabidiol Oral Solution [Epidiolex]<br>* 100 mg BID for three months Placebo oral solution for three months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eyeblink analysis from high speed videocamera recordings - see separate outcome measures | All patients will undergo video recording of their eyelid kinematics at days 0, 45, 90, 135, and 180. A high-resolution commercially available video camera will capture the eyelid positions at a sampling rate of thirty frames per second. Patients will be assessed in three different lighting conditions - in regular exam room lighting, under examination with the glare source of an indirect ophthalmoscope (at 2000 lux on both eyes from 5 feet), and in dim lighting. The upper and lower eyelid positions captured from each frame of the videos will be input into custom software developed by Visage Technologies, which fits a feature template to the facial features in each frame, including the upper and lower lids of each eye. The difference between the upper and lower lid positions defined the lid aperture, also known as the palpebral fissure. The eyeblink parameters will then calculated from the eyelid aperture time series with custom software written in MATLAB. | 4 measurements over 6 months | 
| Median Blink Amplitude | Measured in millimeters (mm) | 4 measurements over 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Blink Duration | Measured in milliseconds (ms) | 4 measurements over 6 months | 
| Median Max Blink Velocity | Measured in millimeters per milliseconds (mm/ms) | 4 measurements over 6 months | 
| Number of Blinks per 100ms | Total blinks in 100 milliseconds (numeric value) | 4 measurements over 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cannabidiol, Epidiolex, Botulinum Toxin, Eyeblink analysis, Videorecording, Blepharospasm, BEB