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

Last updated: October 29, 2021
Sponsor: Silkiss Eye Surgery
Overall Status: Completed

Phase

2/3

Condition

Progressive Supranuclear Palsy

Dystonias

Dyskinesias

Treatment

N/A

Clinical Study ID

NCT04423341
1268646
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 12
Study Start date:
May 20, 2020
Estimated Completion Date:
October 01, 2021

Connect with a study center

  • Silkiss Eye Surgery

    Oakland, California 94609
    United States

    Site Not Available

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