An interventional study of Zinc Supplement and Sugar pill in Blepharospasm and Hemifacial Spasm, sponsored by St. Joseph's Healthcare Hamilton. Status unknown at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-07.
Sponsored by St. Joseph's Healthcare Hamilton · Not applicable, Interventional, and Treatment
The purpose of this study is to determine whether zinc supplements are effective in enhancing the treatment of oculofacial spasm disorders with botulinum toxin.
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.
Exclusion Criteria:
Drug: Sugar pill
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.
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.
Jankovic Rating Scale
a well established scale used in the literature to grade the symptoms of patients with facial spasms disorders.
Time frame: 3 months post Botox injection
Treatment Duration Cycle
The number of days between the date of Botox injection to the date in which the symptoms have returned back to baseline.
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.
Blepharospasm Disability Index (BDI)
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.
Time frame: 3 months post Botox injection
This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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St. Joseph's Healthcare Hamilton