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

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Brief Title

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

Official Title

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

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 Type

Interventional


Primary Outcome

Jankovic Rating Scale

Secondary Outcome

 Treatment Duration Cycle

Condition

Blepharospasm

Intervention

Zinc Supplement

Study Arms / Comparison Groups

 Placebo
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

40

Start Date

April 2012

Completion Date

March 2013

Primary Completion Date

December 2012

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

John Harvey, MD, 9054073882, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT01546805

Organization ID

R.P. #11-3601


Responsible Party

Sponsor

Study Sponsor

St. Joseph's Healthcare Hamilton


Study Sponsor

John Harvey, MD, Principal Investigator, St Joseph's Hospital Hamilton


Verification Date

March 2012