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

Sponsor

Silkiss Eye Surgery (Other)

Overall Status

Completed

CT.gov ID

NCT04423341

Collaborator

Benign Essential Blepharospasm Research Foundation (Other), Jazz Pharmaceuticals (Industry), Smith-Kettlewell Eye Research Institute (Other)

Enrollment

Location

Arms

16.4

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Blepharospasm Blepharospasm, Benign Essential CBD	Drug: Cannabidiol Oral Solution [Epidiolex]	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 20, 2020

Actual Primary Completion Date :

Mar 22, 2021

Actual Study Completion Date :

Oct 1, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Group A - active medication followed by placebo

Drug: Cannabidiol Oral Solution [Epidiolex]

100 mg BID for three months Placebo oral solution for three months

Active Comparator: Group B - placebo followed by active medication

Drug: Cannabidiol Oral Solution [Epidiolex]

100 mg BID for three months Placebo oral solution for three months

Outcome Measures

Primary Outcome Measures

Eyeblink analysis from high speed videocamera recordings - see separate outcome measures [4 measurements over 6 months]
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.
Median Blink Amplitude [4 measurements over 6 months]
Measured in millimeters (mm)

Secondary Outcome Measures

Median Blink Duration [4 measurements over 6 months]
Measured in milliseconds (ms)
Median Max Blink Velocity [4 measurements over 6 months]
Measured in millimeters per milliseconds (mm/ms)
Number of Blinks per 100ms [4 measurements over 6 months]
Total "blinks" in 100 milliseconds (numeric value)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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