BlepharospasmPhase 2/3NCT04423341
Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm
A Phase 2/3 study testing Cannabidiol Oral Solution [Epidiolex] in people with Blepharospasm and Blepharospasm, Benign Essential, run by Silkiss Eye Surgery at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blepharospasm, Blepharospasm, Benign Essential, CBD
- What is being tested?
- Cannabidiol Oral Solution [Epidiolex]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2020to 1 Oct 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm - a Prospective Double-masked Cross-over Study
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
- Being tested
- Cannabidiol Oral Solution [Epidiolex]
- Keywords
- Cannabidiol, Epidiolex, Botulinum Toxin, Eyeblink analysis, Videorecording, Blepharospasm, BEB
- Medical subject headings
- Blepharospasm, Benign essential blepharospasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol Oral Solution [Epidiolex]Drug
100 mg BID for three months Placebo oral solution for three months
| Study group | Role | What they receive |
|---|---|---|
| Group A - active medication followed by placebo | Active comparator | Not described Receives: Drug: Cannabidiol Oral Solution [Epidiolex] |
| Group B - placebo followed by active medication | Active comparator | Not described Receives: Drug: Cannabidiol Oral Solution [Epidiolex] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eyeblink analysis from high speed videocamera recordings - see separate outcome measures
All patients will undergo video recording of their eyelid kinematics at days 0, 45, 90, 135, and 180. A high-resolution commercially available video camera will capture the eyelid positions at a sampling rate of thirty frames per second. Patients will be assessed in three different lighting conditions - in regular exam room lighting, under examination with the glare source of an indirect ophthalmoscope (at 2000 lux on both eyes from 5 feet), and in dim lighting. The upper and lower eyelid positions captured from each frame of the videos will be input into custom software developed by Visage Technologies, which fits a feature template to the facial features in each frame, including the upper and lower lids of each eye. The difference between the upper and lower lid positions defined the lid aperture, also known as the palpebral fissure. The eyeblink parameters will then calculated from the eyelid aperture time series with custom software written in MATLAB.
Measured: 4 measurements over 6 months
Median Blink Amplitude
Measured in millimeters (mm)
Measured: 4 measurements over 6 months
Secondary outcomes (3)
Median Blink Duration
Measured in milliseconds (ms)
Measured: 4 measurements over 6 months
Median Max Blink Velocity
Measured in millimeters per milliseconds (mm/ms)
Measured: 4 measurements over 6 months
Number of Blinks per 100ms
Total "blinks" in 100 milliseconds (numeric value)
Measured: 4 measurements over 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start20 May 2020
- Primary completion22 Mar 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BlepharospasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silkiss Eye Surgery
- Sponsor type
- University, hospital or other
- Collaborators
- Benign Essential Blepharospasm Research Foundation, GW Pharmaceuticals Ltd, Smith-Kettlewell Eye Research Institute
- Responsible party
- Principal investigator, Rona Silkiss, MD FACS, Silkiss Eye Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423341
- Sponsor's protocol ID
- 1268646
- Status last verified
- Oct 2021
- First submitted
- 28 May 2020
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 37606606
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm - a Prospective Double-masked Cross-over Study
- ClinicalTrials.gov ID
- NCT04423341
- Acronym / sponsor ID
- 1268646
- Conditions
- Blepharospasm, Blepharospasm, Benign Essential, CBD
- Keywords
- Cannabidiol, Epidiolex, Botulinum Toxin, Eyeblink analysis, Videorecording, Blepharospasm, BEB
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Silkiss Eye SurgeryUniversity, hospital or other
- Collaborators
- Benign Essential Blepharospasm Research Foundation, GW Pharmaceuticals Ltd, Smith-Kettlewell Eye Research Institute
- Study start
- 20 May 2020 (actual)
- Primary completion
- 22 Mar 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - active medication followed by placebo | Active comparator | Drug: Cannabidiol Oral Solution [Epidiolex] |
| Group B - placebo followed by active medication | Active comparator | Drug: Cannabidiol Oral Solution [Epidiolex] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol Oral Solution [Epidiolex]100 mg BID for three months Placebo oral solution for three months | Drug | Group A - active medication followed by placebo, Group B - placebo followed by active medication |
Primary outcome
Eyeblink analysis from high speed videocamera recordings - see separate outcome measures
Time frame: 4 measurements over 6 months
All patients will undergo video recording of their eyelid kinematics at days 0, 45, 90, 135, and 180. A high-resolution commercially available video camera will capture the eyelid positions at a sampling rate of thirty frames per second. Patients will be assessed in three different lighting conditions - in regular exam room lighting, under examination with the glare source of an indirect ophthalmoscope (at 2000 lux on both eyes from 5 feet), and in dim lighting. The upper and lower eyelid positions captured from each frame of the videos will be input into custom software developed by Visage Technologies, which fits a feature template to the facial features in each frame, including the upper and lower lids of each eye. The difference between the upper and lower lid positions defined the lid aperture, also known as the palpebral fissure. The eyeblink parameters will then calculated from the eyelid aperture time series with custom software written in MATLAB.
Median Blink Amplitude
Time frame: 4 measurements over 6 months
Measured in millimeters (mm)
3 secondary outcomes
Median Blink Duration
Time frame: 4 measurements over 6 months
Median Max Blink Velocity
Time frame: 4 measurements over 6 months
Number of Blinks per 100ms
Time frame: 4 measurements over 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Derived from this study: PubMed 37606606Silkiss 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cannabidiol Oral Solution [Epidiolex] in people with Blepharospasm and Blepharospasm, Benign Essential, run by Silkiss Eye Surgery at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eyeblink analysis from high speed videocamera recordings - see separate outcome measures (time frame: 4 measurements over 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04423341, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.