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

NCT04423341 | Completed Phase 2 FDA Drug

• 1 other identifier: 1268646
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Blepharospasm; Blepharospasm, Benign Essential; CBD

Keywords

Cannabidiol; Epidiolex; Botulinum Toxin; Eyeblink analysis; Videorecording; Blepharospasm; BEB

Outcome Measures

Primary Outcomes (2)

• 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

• Median Blink Amplitude

  Measured in millimeters (mm)

  4 measurements over 6 months

Secondary Outcomes (3)

• Median Blink Duration

  4 measurements over 6 months

• Median Max Blink Velocity

  4 measurements over 6 months

• Number of Blinks per 100ms

  4 measurements over 6 months

Study Arms (2)

Group A - active medication followed by placebo

ACTIVE COMPARATOR

Drug: Cannabidiol Oral Solution [Epidiolex]

Group B - placebo followed by active medication

ACTIVE COMPARATOR

Drug: Cannabidiol Oral Solution [Epidiolex]

Interventions

Cannabidiol Oral Solution [Epidiolex] DRUG

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

Group A - active medication followed by placebo; Group B - placebo followed by active medication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Silkiss Eye Surgery: lead
• Benign Essential Blepharospasm Research Foundation: collaborator
• GW Pharmaceuticals Ltd: collaborator
• Smith-Kettlewell Eye Research Institute: collaborator

Study Sites (1)

Silkiss Eye Surgery

Oakland, California, 94609, United States

Location

Related Publications (1)

• Silkiss RZ, Koppinger J, Truong T, Gibson D, Tyler C. Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm - A Randomized Pilot Study. Transl Vis Sci Technol. 2023 Aug 1;12(8):17. doi: 10.1167/tvst.12.8.17.

  PMID: 37606606 DERIVED

MeSH Terms

Conditions

Blepharospasm; Benign essential blepharospasm

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 9, 2020
• Study Start: May 20, 2020
• Primary Completion: March 22, 2021
• Study Completion: October 1, 2021
• Last Updated: November 2, 2021

Record last verified: 2021-10

Locations

US (1)