Testing the Effect of Zinc Supplementation to Improve the Treatment Effect of Botulinum Toxin for Oculofacial Spasm
Recruitment status was Not yet recruiting
The purpose of this study is to determine whether zinc supplements are effective in enhancing the treatment of oculofacial spasm disorders with botulinum toxin.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effect of Zinc Supplementation on the Efficacy and Duration of Botulinum Toxin for the Treatment of Oculofacial Spasm Disorders|
- Jankovic Rating Scale [ Time Frame: 3 months post Botox injection ] [ Designated as safety issue: No ]a well established scale used in the literature to grade the symptoms of patients with facial spasms disorders.
- 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. ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||
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.
|Experimental: Zinc Group||
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546805
|Contact: Gamal Seif, MDfirstname.lastname@example.org|
|Contact: John Harvey, MDemail@example.com|
|St Joseph's Hospital Hamilton||Not yet recruiting|
|Hamilton, Ontario, Canada, L8N4A6|
|Contact: Gamal Seif, MD 9054073882 firstname.lastname@example.org|
|Principal Investigator: John Harvey, MD|
|Carrot Eye Centre||Not yet recruiting|
|Mississauga, Ontario, Canada, L5J 2Y2|
|Contact: Yasser Khan, MD 905-822-2020|
|Principal Investigator: Yasser Khan, MD|
|Principal Investigator:||John Harvey, MD||St Joseph's Hospital Hamilton|
|Principal Investigator:||Yasser Khan, MD||McMaster University|