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

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.

Study Overview

• Status: Completed
• Conditions: CBD; Blepharospasm; Blepharospasm, Benign Essential
• Intervention / Treatment: Drug: Cannabidiol Oral Solution [Epidiolex]

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94609
      • Silkiss Eye Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Silkiss Eye Surgery
• Collaborators: Jazz Pharmaceuticals; Smith-Kettlewell Eye Research Institute; Benign Essential Blepharospasm Research Foundation

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Actual): March 22, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: June 7, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 29, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Botulinum Toxin; Cannabidiol; Epidiolex; Blepharospasm; Eyeblink analysis; Videorecording; BEB
• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Blepharospasm; Anticonvulsants; Cannabidiol
• Other Study ID Numbers: 1268646

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes