NCT04423341 is a Phase 2, PHASE3 clinical trial of Cannabidiol Oral Solution [Epidiolex] in Blepharospasm, sponsored by Silkiss Eye Surgery.

Who is sponsoring NCT04423341?

NCT04423341 is sponsored by Silkiss Eye Surgery.

What drugs are being tested in NCT04423341?

Interventions in NCT04423341: Cannabidiol Oral Solution [Epidiolex].

What condition does NCT04423341 study?

NCT04423341 studies Blepharospasm, Blepharospasm, Benign Essential, CBD.

Is NCT04423341 still recruiting?

NCT04423341 is currently completed. Last updated 2 November 2021.

Last reviewed 2021-11-02 · How we verify

NCT04423341

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2, PHASE3 Last updated 2 November 2021

What this trial tests

Phase 2, PHASE3 trial testing Cannabidiol Oral Solution [Epidiolex] in Blepharospasm in 12 participants. Completed in 1 October 2021.

Timeline

20 May 2020

Primary endpoint
22 March 2021

1 October 2021

Quick facts

Lead sponsor	Silkiss Eye Surgery
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	12
Start date	20 May 2020
Primary completion	22 March 2021
Estimated completion	1 October 2021
Sites	1 location across United States

Drugs / interventions tested

Cannabidiol Oral Solution [Epidiolex] — full drug profile →

Conditions studied

Blepharospasm — all drugs for Blepharospasm →
Blepharospasm, Benign Essential — all drugs for Blepharospasm, Benign Essential →
CBD — all drugs for CBD →

Sponsor

Silkiss Eye Surgery — full company profile →

Who can join

18 and older, any sex, with Blepharospasm or Blepharospasm, Benign Essential. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm - A Randomized Pilot Study.
Silkiss RZ, Koppinger J, Truong T, Gibson D, et al · · 2023 · cited 1× · PMID 37606606 · DOI 10.1167/tvst.12.8.17

Verify or expand the search:

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04423341 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Silkiss Eye Surgery
Last refreshed: 2 November 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04423341.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing