Testing the Effect of Zinc Supplementation to Improve the Treatment Effect of Botulinum Toxin for Oculofacial Spasm
Primary Purpose
Blepharospasm, Hemifacial Spasm
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Zinc Supplement
Sugar pill
Sponsored by
About this trial
This is an interventional treatment trial for Blepharospasm focused on measuring Blepharospasm, Hemifacial spasm, Botox, Zinc
Eligibility Criteria
Inclusion Criteria:
- greater than the age 18 years old
- patient with hemifacial spasm
- patient with benign essential blepharospasm.
Exclusion Criteria:
- patients who have received Botox within 3 months time,
- patients prone to malabsorption (i.e. those with Celiac disease, inflammatory bowel disease, liver disease, laxative use)
- patients who cannot tolerate zinc supplementation due to kidney disease, gastrointestinal disease, or any other medical condition.
Sites / Locations
- St Joseph's Hospital Hamilton
- Carrot Eye Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Zinc Group
Arm Description
Outcomes
Primary Outcome Measures
Jankovic Rating Scale
a well established scale used in the literature to grade the symptoms of patients with facial spasms disorders.
Secondary Outcome Measures
Treatment Duration Cycle
The number of days between the date of Botox injection to the date in which the symptoms have returned back to baseline.
Blepharospasm Disability Index (BDI)
BDI is a scale commonly used in the Blepharospasm literature to measure the magnitude of the burden of symptoms in patients with Blepharospasm. It has also been used to measure treatment effect by a reduction in patient's BDI.
Full Information
NCT ID
NCT01546805
First Posted
February 16, 2012
Last Updated
March 1, 2012
Sponsor
St. Joseph's Healthcare Hamilton
1. Study Identification
Unique Protocol Identification Number
NCT01546805
Brief Title
Testing the Effect of Zinc Supplementation to Improve the Treatment Effect of Botulinum Toxin for Oculofacial Spasm
Official Title
The Effect of Zinc Supplementation on the Efficacy and Duration of Botulinum Toxin for the Treatment of Oculofacial Spasm Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
March 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Joseph's Healthcare Hamilton
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether zinc supplements are effective in enhancing the treatment of oculofacial spasm disorders with botulinum toxin.
Detailed Description
Botulinum Toxin (Botox) has been used for many years in the treatment of oculofacial dystonias such as blepharospasm and hemifacial spasm. It has also gained widespread use for cosmetic purposes. The efficacy and duration of its effect is not constant amongst all patients. Some patient respond very well, while others have no clinical benefit or the clinical benefit does not last as long as expected. Zinc is known to be an important co-factor in the molecular effects of Botox. The investigators hypothesize that one of the many factors that may contribute to the variability in the response to Botox may be the level of Zinc available within the neuromuscular junction of those patients. The investigators plan to to test whether or not giving patients supplemental Zinc with their Botox injections would help improve the magnitude and duration of the intended clinical effect.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharospasm, Hemifacial Spasm
Keywords
Blepharospasm, Hemifacial spasm, Botox, Zinc
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Zinc Group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Zinc Supplement
Intervention Description
The interventional group will be requested to take zinc supplements (50mg), once daily starting 5 days prior to Botox injections and to be continued for 5 days after injection.
Intervention Type
Drug
Intervention Name(s)
Sugar pill
Intervention Description
The control group will be requested to take placebo pills, once daily starting 5 days prior to Botox injections and to be continued for 5 days after injection.
Primary Outcome Measure Information:
Title
Jankovic Rating Scale
Description
a well established scale used in the literature to grade the symptoms of patients with facial spasms disorders.
Time Frame
3 months post Botox injection
Secondary Outcome Measure Information:
Title
Treatment Duration Cycle
Description
The number of days between the date of Botox injection to the date in which the symptoms have returned back to baseline.
Time Frame
The time frame will vary with each patient. The time frame is in fact the outcome measure being measured. On average the Botox treatment cycles last 3 months, however this average may be affected by zinc supplements.
Title
Blepharospasm Disability Index (BDI)
Description
BDI is a scale commonly used in the Blepharospasm literature to measure the magnitude of the burden of symptoms in patients with Blepharospasm. It has also been used to measure treatment effect by a reduction in patient's BDI.
Time Frame
3 months post Botox injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
greater than the age 18 years old
patient with hemifacial spasm
patient with benign essential blepharospasm.
Exclusion Criteria:
patients who have received Botox within 3 months time,
patients prone to malabsorption (i.e. those with Celiac disease, inflammatory bowel disease, liver disease, laxative use)
patients who cannot tolerate zinc supplementation due to kidney disease, gastrointestinal disease, or any other medical condition.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gamal Seif, MD
Phone
9054073882
Email
gamal.seif@medportal.ca
First Name & Middle Initial & Last Name or Official Title & Degree
John Harvey, MD
Phone
905-573-4848
Email
jtharvey@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Harvey, MD
Organizational Affiliation
St Joseph's Hospital Hamilton
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yasser Khan, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Joseph's Hospital Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N4A6
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gamal Seif, MD
Phone
9054073882
Email
gamal.seif@medportal.ca
First Name & Middle Initial & Last Name & Degree
John Harvey, MD
Facility Name
Carrot Eye Centre
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5J 2Y2
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasser Khan, MD
Phone
905-822-2020
First Name & Middle Initial & Last Name & Degree
Yasser Khan, MD
12. IPD Sharing Statement
Learn more about this trial
Testing the Effect of Zinc Supplementation to Improve the Treatment Effect of Botulinum Toxin for Oculofacial Spasm
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