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

NCT04423341 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-11-02

No results posted yet for this 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.

Conditions

  • Blepharospasm
  • Blepharospasm, Benign Essential
  • CBD

Interventions

DRUG

Cannabidiol Oral Solution [Epidiolex]

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

Sponsors & Collaborators

  • Benign Essential Blepharospasm Research Foundation

    collaborator OTHER

  • GW Pharmaceuticals Ltd

    collaborator INDUSTRY

  • Smith-Kettlewell Eye Research Institute

    collaborator OTHER

  • Silkiss Eye Surgery

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-20
Primary Completion
2021-03-22
Completion
2021-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04423341 on ClinicalTrials.gov