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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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 Summary: 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.
Sponsor: St. Joseph's Healthcare Hamilton

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: St. Joseph's Healthcare Hamilton

Dates:
Date Received: February 16, 2012
Date Started: April 2012
Date Completion: March 2013
Last Updated: March 1, 2012
Last Verified: March 2012