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

Not Applicable

• Conditions: Blepharospasm; Hemifacial Spasm
• Interventions: Drug: Zinc Supplement; Drug: Sugar pill

• Registration Number: NCT01546805
• Lead Sponsor: St. Joseph's Healthcare Hamilton

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 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.

Study Timeline

• Study First Submitted: 2012-02-16
• Status Verified: 2012-03
• Study First Submitted QC: 2012-03-01
• Last Update Submitted: 2012-03-01
• Study First Posted: 2012-03-07
• Last Update Posted: 2012-03-07
• Study Start: 2012-04
• Primary Completion: 2012-12
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zinc Group	Zinc Supplement	-
Placebo	Sugar pill	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Treatment Duration Cycle	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)	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.

Trial Locations

Locations (2)

St Joseph's Hospital Hamilton; 🇨🇦 Hamilton, Ontario, Canada

Carrot Eye Centre; 🇨🇦 Mississauga, Ontario, Canada