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Completed

NCT Number: NCT04423341

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

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.

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Key information

Conditions

Blepharospasm Benign essential blepharospasm Blepharospasm, Benign Essential CBD Eye Diseases Eyelid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Silkiss Eye Surgery

Oakland, California, 94609, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cannabidiol Oral Solution [Epidiolex]

Drug

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

Primary outcomes

  1. Eyeblink analysis from high speed videocamera recordings - see separate outcome measures

    Time frame: 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.

  2. Median Blink Amplitude

    Time frame: 4 measurements over 6 months

    Measured in millimeters (mm)

Secondary outcomes

  1. Median Blink Duration

    Time frame: 4 measurements over 6 months

    Measured in milliseconds (ms)

  2. Median Max Blink Velocity

    Time frame: 4 measurements over 6 months

    Measured in millimeters per milliseconds (mm/ms)

  3. Number of Blinks per 100ms

    Time frame: 4 measurements over 6 months

    Total "blinks" in 100 milliseconds (numeric value)

Sponsors and collaborators

Lead sponsor

Silkiss Eye Surgery

Other

Collaborators

  • Benign Essential Blepharospasm Research Foundation
  • GW Pharmaceuticals Ltd
  • Smith-Kettlewell Eye Research Institute

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 9, 2020
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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