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ClinicalTrials.gov ID

NCT01546805

Lead Sponsor

St. Joseph's Healthcare HamiltonOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

40Estimated

Last Update Posted

Mar 7, 2012Estimated

Start Date

Apr 2012

Primary Completion Date

Dec 2012Estimated

Completion Date

Mar 2013Estimated

Official Title

The Effect of Zinc Supplementation on the Efficacy and Duration of Botulinum Toxin for the Treatment of Oculofacial Spasm Disorders

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.

• Blepharospasm
• Hemifacial Spasm

• Zinc Supplement
• Sugar pill

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

St. Joseph's Healthcare HamiltonOTHER

905-822-2020