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

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ClinicalTrials.gov Identifier: NCT01546805
Recruitment Status : Unknown
Verified March 2012 by St. Joseph's Healthcare Hamilton.
Recruitment status was:  Not yet recruiting
First Posted : March 7, 2012
Last Update Posted : March 7, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Blepharospasm Hemifacial Spasm Drug: Zinc Supplement Drug: Sugar pill

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : April 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : March 2013


Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.


Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01546805


Contacts
Contact: Gamal Seif, MD 9054073882 gamal.seif@medportal.ca
Contact: John Harvey, MD 905-573-4848 jtharvey@mcmaster.ca

Locations
Canada, Ontario
St Joseph's Hospital Hamilton Not yet recruiting
Hamilton, Ontario, Canada, L8N4A6
Contact: Gamal Seif, MD    9054073882    gamal.seif@medportal.ca   
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
Investigators
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
ClinicalTrials.gov Identifier: NCT01546805     History of Changes
Other Study ID Numbers: R.P. #11-3601
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: March 7, 2012
Last Verified: March 2012

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

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