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

NCT ID: NCT04423341

Last Updated: 2021-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-20

Study Completion Date

2021-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Blepharospasm Blepharospasm, Benign Essential CBD

Keywords

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Cannabidiol Epidiolex Botulinum Toxin Eyeblink analysis Videorecording Blepharospasm BEB

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group A - active medication followed by placebo

Group Type ACTIVE_COMPARATOR

Cannabidiol Oral Solution [Epidiolex]

Intervention Type DRUG

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

Group B - placebo followed by active medication

Group Type ACTIVE_COMPARATOR

Cannabidiol Oral Solution [Epidiolex]

Intervention Type DRUG

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

Interventions

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Cannabidiol Oral Solution [Epidiolex]

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Benign Essential Blepharospasm Research Foundation

OTHER

Sponsor Role collaborator

GW Pharmaceuticals Ltd

INDUSTRY

Sponsor Role collaborator

Smith-Kettlewell Eye Research Institute

OTHER

Sponsor Role collaborator

Silkiss Eye Surgery

OTHER

Sponsor Role lead

Responsible Party

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Rona Silkiss, MD FACS

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Silkiss Eye Surgery

Oakland, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37606606 (View on PubMed)

Other Identifiers

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1268646

Identifier Type: -

Identifier Source: org_study_id