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

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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

, , 

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

, , 


Verification Date

June 2020