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 because the information has not been verified recently.
Verified March 2012 by St. Joseph's Healthcare Hamilton.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT01546805
First received: February 16, 2012
Last updated: March 1, 2012
Last verified: March 2012

February 16, 2012
March 1, 2012
April 2012
December 2012   (final data collection date for primary outcome measure)
Jankovic Rating Scale [ Time Frame: 3 months post Botox injection ] [ Designated as safety issue: No ]
a well established scale used in the literature to grade the symptoms of patients with facial spasms disorders.
Same as current
Complete list of historical versions of study NCT01546805 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Blepharospasm
  • Hemifacial Spasm
  • 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.
  • 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.
  • Placebo Comparator: Placebo
    Intervention: Drug: Sugar pill
  • Experimental: Zinc Group
    Intervention: Drug: Zinc Supplement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
March 2013
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Gamal Seif, MD 9054073882 gamal.seif@medportal.ca
Contact: John Harvey, MD 905-573-4848 jtharvey@mcmaster.ca
Canada
 
NCT01546805
R.P. #11-3601
No
St. Joseph's Healthcare Hamilton
St. Joseph's Healthcare Hamilton
Not Provided
Principal Investigator: John Harvey, MD St Joseph's Hospital Hamilton
Principal Investigator: Yasser Khan, MD McMaster University
St. Joseph's Healthcare Hamilton
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP