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

Overview

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

Full Title of Study: “The Effect of Zinc Supplementation on the Efficacy and Duration of Botulinum Toxin for the Treatment of Oculofacial Spasm Disorders”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2012

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.

Interventions

  • Drug: 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.
  • 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.

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
  • Experimental: Zinc Group

Clinical Trial Outcome Measures

Primary Measures

  • Jankovic Rating Scale
    • Time Frame: 3 months post Botox injection
    • a well established scale used in the literature to grade the symptoms of patients with facial spasms disorders.

Secondary Measures

  • Treatment Duration Cycle
    • 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.
    • 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)
    • Time Frame: 3 months post Botox injection
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • St. Joseph’s Healthcare Hamilton
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • John Harvey, MD, Principal Investigator, St Joseph’s Hospital Hamilton
    • Yasser Khan, MD, Principal Investigator, McMaster University
  • Overall Contact(s)
    • Gamal Seif, MD, 9054073882, gamal.seif@medportal.ca

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