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

Blepharospasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04423341
• Other study ID #: 1268646
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 20, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2021
• Source: Silkiss Eye Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 1, 2021
• Est. primary completion date: March 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blepharospasm
• Blepharospasm, Benign Essential
• CBD

Intervention

Drug:
• Cannabidiol Oral Solution [Epidiolex]
100 mg BID for three months Placebo oral solution for three months

Locations

Country	Name	City	State
United States	Silkiss Eye Surgery	Oakland	California

Sponsors (4)

Lead Sponsor	Collaborator
Silkiss Eye Surgery	Benign Essential Blepharospasm Research Foundation, GW Pharmaceuticals Ltd., Smith-Kettlewell Eye Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Median Blink Amplitude	Measured in millimeters (mm)	4 measurements over 6 months
Secondary	Median Blink Duration	Measured in milliseconds (ms)	4 measurements over 6 months
Secondary	Median Max Blink Velocity	Measured in millimeters per milliseconds (mm/ms)	4 measurements over 6 months
Secondary	Number of Blinks per 100ms	Total "blinks" in 100 milliseconds (numeric value)	4 measurements over 6 months