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

Primary Purpose

Blepharospasm, Blepharospasm, Benign Essential, CBD

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cannabidiol Oral Solution [Epidiolex]
Sponsored by
Silkiss Eye Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blepharospasm focused on measuring Cannabidiol, Epidiolex, Botulinum Toxin, Eyeblink analysis, Videorecording, Blepharospasm, BEB

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Silkiss Eye Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A - active medication followed by placebo

Group B - placebo followed by active medication

Arm Description

Outcomes

Primary Outcome Measures

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.
Median Blink Amplitude
Measured in millimeters (mm)

Secondary Outcome Measures

Median Blink Duration
Measured in milliseconds (ms)
Median Max Blink Velocity
Measured in millimeters per milliseconds (mm/ms)
Number of Blinks per 100ms
Total "blinks" in 100 milliseconds (numeric value)

Full Information

First Posted
May 28, 2020
Last Updated
October 29, 2021
Sponsor
Silkiss Eye Surgery
Collaborators
Benign Essential Blepharospasm Research Foundation, Jazz Pharmaceuticals, Smith-Kettlewell Eye Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04423341
Brief Title
Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm
Official Title
Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm - a Prospective Double-masked Cross-over Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 20, 2020 (Actual)
Primary Completion Date
March 22, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Silkiss Eye Surgery
Collaborators
Benign Essential Blepharospasm Research Foundation, Jazz Pharmaceuticals, Smith-Kettlewell Eye Research Institute

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharospasm, Blepharospasm, Benign Essential, CBD
Keywords
Cannabidiol, Epidiolex, Botulinum Toxin, Eyeblink analysis, Videorecording, Blepharospasm, BEB

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A - active medication followed by placebo
Arm Type
Active Comparator
Arm Title
Group B - placebo followed by active medication
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Cannabidiol Oral Solution [Epidiolex]
Intervention Description
100 mg BID for three months Placebo oral solution for three months
Primary Outcome Measure Information:
Title
Eyeblink analysis from high speed videocamera recordings - see separate outcome measures
Description
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.
Time Frame
4 measurements over 6 months
Title
Median Blink Amplitude
Description
Measured in millimeters (mm)
Time Frame
4 measurements over 6 months
Secondary Outcome Measure Information:
Title
Median Blink Duration
Description
Measured in milliseconds (ms)
Time Frame
4 measurements over 6 months
Title
Median Max Blink Velocity
Description
Measured in millimeters per milliseconds (mm/ms)
Time Frame
4 measurements over 6 months
Title
Number of Blinks per 100ms
Description
Total "blinks" in 100 milliseconds (numeric value)
Time Frame
4 measurements over 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Silkiss Eye Surgery
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States

12. IPD Sharing Statement

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

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