Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Blepharospasm Blepharospasm, Benign Essential CBD | Drug: Cannabidiol Oral Solution [Epidiolex] | Phase 2 Phase 3 |
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 |
- 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.
- Median Blink Amplitude [ Time Frame: 4 measurements over 6 months ]Measured in millimeters (mm)
- Median Blink Duration [ Time Frame: 4 measurements over 6 months ]Measured in milliseconds (ms)
- Median Max Blink Velocity [ Time Frame: 4 measurements over 6 months ]Measured in millimeters per milliseconds (mm/ms)
- Number of Blinks per 100ms [ Time Frame: 4 measurements over 6 months ]Total "blinks" in 100 milliseconds (numeric value)

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

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
United States, California | |
Silkiss Eye Surgery | |
Oakland, California, United States, 94609 |
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 |
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 |
Cannabidiol Epidiolex Botulinum Toxin Eyeblink analysis |
Videorecording Blepharospasm BEB |
Blepharospasm Eyelid Diseases Eye Diseases Cannabidiol Anticonvulsants |