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

The Effect of Zinc Supplementation on the Efficacy and Duration of Botulinum Toxin for the Treatment of Oculofacial Spasm Disorders

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 Overview

• Status: Unknown
• Conditions: Hemifacial Spasm; Blepharospasm
• Intervention / Treatment: Drug: Sugar pill; Drug: Zinc Supplement

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gamal Seif, MD; Phone Number: 9054073882; Email: gamal.seif@medportal.ca
• Study Contact Backup: Name: John Harvey, MD; Phone Number: 905-573-4848; Email: jtharvey@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N4A6
      • St Joseph's Hospital Hamilton
      • Contact: Gamal Seif, MD; Phone Number: 9054073882; Email: gamal.seif@medportal.ca
      • Principal Investigator: John Harvey, MD
    • Mississauga, Ontario, Canada, L5J 2Y2
      • Carrot Eye Centre
      • Contact: Yasser Khan, MD; Phone Number: 905-822-2020
      • Principal Investigator: Yasser Khan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3 months post Botox injection

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton
• Investigators: Principal Investigator: John Harvey, MD, St Joseph's Hospital Hamilton; Principal Investigator: Yasser Khan, MD, McMaster University

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): March 1, 2013

Study Registration Dates

• First Submitted: February 16, 2012
• First Submitted That Met QC Criteria: March 1, 2012
• First Posted (Estimate): March 7, 2012

Study Record Updates

• Last Update Posted (Estimate): March 7, 2012
• Last Update Submitted That Met QC Criteria: March 1, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Zinc; Botox; Blepharospasm; Hemifacial spasm
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Mouth Diseases; Neuromuscular Manifestations; Eyelid Diseases; Spasm; Muscle Cramp; Hemifacial Spasm; Blepharospasm
• Other Study ID Numbers: R.P. #11-3601