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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04423341
Recruitment Status : Completed
First Posted : June 9, 2020
Last Update Posted : November 2, 2021
Sponsor:
Collaborators:
Benign Essential Blepharospasm Research Foundation
Jazz Pharmaceuticals
Smith-Kettlewell Eye Research Institute
Information provided by (Responsible Party):
Rona Silkiss, MD FACS, 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.

Condition or disease Intervention/treatment Phase
Blepharospasm Blepharospasm, Benign Essential CBD Drug: Cannabidiol Oral Solution [Epidiolex] Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm - a Prospective Double-masked Cross-over Study
Actual Study Start Date : May 20, 2020
Actual Primary Completion Date : March 22, 2021
Actual Study Completion Date : October 1, 2021


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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04423341


Locations
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United States, California
Silkiss Eye Surgery
Oakland, California, United States, 94609
Sponsors and Collaborators
Silkiss Eye Surgery
Benign Essential Blepharospasm Research Foundation
Jazz Pharmaceuticals
Smith-Kettlewell Eye Research Institute
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Responsible Party: Rona Silkiss, MD FACS, Physician, Silkiss Eye Surgery
ClinicalTrials.gov Identifier: NCT04423341    
Other Study ID Numbers: 1268646
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: November 2, 2021
Last Verified: October 2021

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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
Keywords provided by Rona Silkiss, MD FACS, Silkiss Eye Surgery:
Cannabidiol
Epidiolex
Botulinum Toxin
Eyeblink analysis
Videorecording
Blepharospasm
BEB
Additional relevant MeSH terms:
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Blepharospasm
Eyelid Diseases
Eye Diseases
Cannabidiol
Anticonvulsants