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

S

St. Joseph's Healthcare Hamilton

Status

Unknown

Conditions

Blepharospasm
Hemifacial Spasm

Treatments

Drug: Sugar pill
Drug: Zinc Supplement

Study type

Interventional

Funder types

Other

Identifiers

NCT01546805
R.P. #11-3601

Details and patient eligibility

About

The purpose of this study is to determine whether zinc supplements are effective in enhancing the treatment of oculofacial spasm disorders with botulinum toxin.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Treatment:
Drug: Sugar pill
Zinc Group
Experimental group
Treatment:
Drug: Zinc Supplement

Trial contacts and locations

2

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Central trial contact

John Harvey, MD; Gamal Seif, MD

Data sourced from clinicaltrials.gov

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