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Trial record 43 of 251 for:    epidiolex

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04423341
Recruitment Status : Enrolling by invitation
First Posted : June 9, 2020
Last Update Posted : June 9, 2020
Sponsor:
Collaborators:
Benign Essential Blepharospasm Research Foundation
GW Pharmaceuticals Ltd.
Smith-Kettlewell Eye Research Institute
Information provided by (Responsible Party):
Rona Silkiss, MD FACS, Silkiss Eye Surgery

Brief 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. Additionally, patients will undergo EEG monitoring via a Blink-EEG protocol for objective data measurements of changes induced by CBD in Blepharospasm patients. Independent second measures will be of blink kinematic analysis of review of video recording. Results would also be correlated with the Blepharospasm Severity Disability Index, Modified CDQ-24 scale and Jankovic Rating Scale. To assess any change in anxiety that might be relevant to therapeutic effect, the anxiety scale GAD-7 survey will also be administered and correlated with the results. This study will attempt to codify the data and quantify if adjunctive CBD therapy improves those areas compared to botulinum injection alone.

Condition or disease Intervention/treatment Phase
Blepharospasm Blepharospasm, Benign Essential CBD Drug: Cannabidiol Oral Solution [Epidiolex] Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm - a Prospective Double-masked Cross-over Study
Actual Study Start Date : May 20, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021


Arm Intervention/treatment
Active Comparator: Group A - active medication followed by placebo Drug: Cannabidiol Oral Solution [Epidiolex]
100 mg BID for three months Placebo oral solution for three months

Active Comparator: Group B - placebo followed by active medication Drug: Cannabidiol Oral Solution [Epidiolex]
100 mg BID for three months Placebo oral solution for three months




Primary Outcome Measures :
  1. EEG/EOG measurements [ Time Frame: 4 times over 6 months ]
    EEG/EOG data will be recorded using an EGI Geodesic Netstation high-density, whole head recording system (Electrical Geodesics, Inc., Eugene, OR) using 128 electrodes distributed around the head and face, with the impedance of all electrodes will be maintained below 60 kΩ according to the recommended value for this system. The data will be recorded at a sampling rate of 500 Hz and band-pass filtered between 0.01 and 250 Hz, with the recorded signals for all electrodes being referenced to the vertex electrode. The results wills be measured in μV deflections over time. The results will be assessed for change at each time point over 6 months.

  2. Jankovic Rating Scale [ Time Frame: 4 times over 6 months ]

    The Jankovic Rating Scale is a survey of Blepharospasm Severity and Frequency, each ranked numerically from 0-5 as below:

    Blepharospasm Severity 0 = None

    1. = Minimal, increased blinking present only with external stimuli (i.e., bright light or wind)
    2. = Mild, spontaneous eyelid fluttering (without active spasm). Symptoms are noticeable, possibly embarrassing, but not functionally disabling.
    3. = Moderate, very noticeable spasms of eyelids, only. Mildly incapacitating.
    4. = Severe, incapacitating spasms of eyelids and possibly other facial muscles.

    Blepharospasm Frequency 0 = None

    1. = Slightly increased frequency of blinking.
    2. = Eyelid fluttering lasting less than 1 second in duration.
    3. = Eyelid spasms lasting for more than 1 second, but eyes open more than 50% of wakeful hours.
    4. = Functionally "blind" due to persistent eyelid closure, more than 50% of the waking time

    The results will be assessed for change at each time point over 6 months.



Secondary Outcome Measures :
  1. Blepharospasm Disability Index (BSDI) [ Time Frame: 4 times over 6 months ]

    The BSDI is a survey of symptoms experienced from blepharospasm for activities of daily living, ranked from 0-4 as below:

    Items:

    Reading Driving a vehicle Watching television Shopping Doing everyday activities Getting about on foot

    Ratings 0 = no impairment

    1. = mild impairment
    2. = moderate impairment
    3. = severe impairment
    4. = not possible due to severe disease Not applicable = N/A

  2. Modified CDQ-24 Questionnaire [ Time Frame: 4 times over 6 months ]

    The Modified CDQ-24 Questionnaire is a series of 24 questions surveying how often a specific activity or function is affecting a person. Answers include never/occasionally/sometimes/often/always or not at all/slightly/moderately/severely/very severely.

    This is calculated by assigning scores of 1, 2, 3,4, and 5 to the response categories of "never," "occasionally," "sometimes," "often" and "always" respectively, as well as assigning scores of 1, 2, 3,4, and 5 to the response categories of "not at all," "slightly," "moderately," "severely" and "very severely" respectively.


  3. Generalized Anxiety Disorder-7 [ Time Frame: 4 times over 6 months ]
    This survey asks participants how often they have been bothered by specific problems over the past two weeks. GAD-7 total score for the seven items ranges from 0 to 21. This is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04423341


Locations
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United States, California
Silkiss Eye Surgery
Oakland, California, United States, 94609
Sponsors and Collaborators
Silkiss Eye Surgery
Benign Essential Blepharospasm Research Foundation
GW Pharmaceuticals Ltd.
Smith-Kettlewell Eye Research Institute
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Responsible Party: Rona Silkiss, MD FACS, Physician, Silkiss Eye Surgery
ClinicalTrials.gov Identifier: NCT04423341    
Other Study ID Numbers: 1268646
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Rona Silkiss, MD FACS, Silkiss Eye Surgery:
Cannabidiol
Epidiolex
Botulinum Toxin
EEG
EOG
Blepharospasm
BEB
Additional relevant MeSH terms:
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Blepharospasm
Eyelid Diseases
Eye Diseases
Epidiolex
Anticonvulsants