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
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. Additionally, patients will undergo EEG monitoring via a Blink-EEG protocol for
objective data measurements of changes induced by CBD in Blepharospasm patients. Independent
second measures will be of blink kinematic analysis of review of video recording. Results
would also be correlated with the Blepharospasm Severity Disability Index, Modified CDQ-24
scale and Jankovic Rating Scale. To assess any change in anxiety that might be relevant to
therapeutic effect, the anxiety scale GAD-7 survey will also be administered and correlated
with the results. This study will attempt to codify the data and quantify if adjunctive CBD
therapy improves those areas compared to botulinum injection alone.
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
EEG/EOG measurements
Secondary Outcome
Blepharospasm Disability Index (BSDI)
Condition
Blepharospasm
Intervention
Cannabidiol Oral Solution [Epidiolex]
Study Arms / Comparison Groups
Group A - active medication followed by placebo
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
12
Start Date
May 20, 2020
Completion Date
February 2021
Primary Completion Date
February 2021
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04423341
Organization ID
1268646
Responsible Party
Principal Investigator
Study Sponsor
Silkiss Eye Surgery
Collaborators
Benign Essential Blepharospasm Research Foundation
Study Sponsor
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Verification Date
June 2020