Testing the Effect of Zinc Supplementation to Improve the Treatment Effect of Botulinum Toxin for Oculofacial Spasm

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-03-31

Brief Summary

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The purpose of this study is to determine whether zinc supplements are effective in enhancing the treatment of oculofacial spasm disorders with botulinum toxin.

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Detailed Description

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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.

Conditions

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Blepharospasm Hemifacial Spasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Sugar pill

Intervention Type DRUG

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.

Zinc Group

Group Type EXPERIMENTAL

Zinc Supplement

Intervention Type DRUG

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.

Interventions

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Zinc Supplement

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

Sugar pill

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No