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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by St. Joseph's Healthcare Hamilton.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
St. Joseph's Healthcare Hamilton Identifier:
First received: February 16, 2012
Last updated: March 1, 2012
Last verified: March 2012
The purpose of this study is to determine whether zinc supplements are effective in enhancing the treatment of oculofacial spasm disorders with botulinum toxin.

Condition Intervention
Blepharospasm Hemifacial Spasm Drug: Zinc Supplement Drug: Sugar pill

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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

Resource links provided by NLM:

Further study details as provided by St. Joseph's Healthcare Hamilton:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 40
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)
Arms Assigned Interventions
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.

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01546805

Contact: Gamal Seif, MD 9054073882
Contact: John Harvey, MD 905-573-4848

Canada, Ontario
St Joseph's Hospital Hamilton Not yet recruiting
Hamilton, Ontario, Canada, L8N4A6
Contact: Gamal Seif, MD    9054073882   
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         
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Principal Investigator: John Harvey, MD St Joseph's Hospital Hamilton
Principal Investigator: Yasser Khan, MD McMaster University
  More Information

Responsible Party: St. Joseph's Healthcare Hamilton Identifier: NCT01546805     History of Changes
Other Study ID Numbers: R.P. #11-3601
Study First Received: February 16, 2012
Last Updated: March 1, 2012

Keywords provided by St. Joseph's Healthcare Hamilton:
Hemifacial spasm

Additional relevant MeSH terms:
Muscle Cramp
Hemifacial Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Eyelid Diseases
Eye Diseases
Mouth Diseases
Stomatognathic Diseases
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Trace Elements
Growth Substances processed this record on September 21, 2017