Testing the Effect of Zinc Supplementation to Improve the Treatment Effect of Botulinum Toxin for Oculofacial Spasm
The Effect of Zinc Supplementation on the Efficacy and Duration of Botulinum Toxin for the Treatment of Oculofacial Spasm Disorders
1 other identifier
interventional
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2012
CompletedFirst Posted
Study publicly available on registry
March 7, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMarch 7, 2012
March 1, 2012
8 months
February 16, 2012
March 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Jankovic Rating Scale
a well established scale used in the literature to grade the symptoms of patients with facial spasms disorders.
3 months post Botox injection
Secondary Outcomes (2)
Treatment Duration Cycle
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.
Blepharospasm Disability Index (BDI)
3 months post Botox injection
Study Arms (2)
Placebo
PLACEBO COMPARATORZinc Group
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- greater than the age 18 years old
- patient with hemifacial spasm
- patient with benign essential blepharospasm.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
St Joseph's Hospital Hamilton
Hamilton, Ontario, L8N4A6, Canada
Carrot Eye Centre
Mississauga, Ontario, L5J 2Y2, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Harvey, MD
St Joseph's Hospital Hamilton
- PRINCIPAL INVESTIGATOR
Yasser Khan, MD
McMaster University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2012
First Posted
March 7, 2012
Study Start
April 1, 2012
Primary Completion
December 1, 2012
Study Completion
March 1, 2013
Last Updated
March 7, 2012
Record last verified: 2012-03