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

Phase 2

Completed

• Conditions: Blepharospasm; CBD; Blepharospasm, Benign Essential
• Interventions: Drug: Cannabidiol Oral Solution [Epidiolex]

• Registration Number: NCT04423341
• Lead Sponsor: Silkiss Eye Surgery

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-20
• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-06-07
• Study First Posted: 2020-06-09
• Primary Completion: 2021-03-22
• Status Verified: 2021-10
• Study Completion: 2021-10-01
• Last Update Submitted: 2021-10-29
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A - active medication followed by placebo	Cannabidiol Oral Solution [Epidiolex]	-
Group B - placebo followed by active medication	Cannabidiol Oral Solution [Epidiolex]	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Silkiss Eye Surgery; 🇺🇸 Oakland, California, United States