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

Blepharospasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01546805
• Other study ID #: R.P. #11-3601
• Status: Not yet recruiting
• Phase: N/A
• First received: February 16, 2012
• Last updated: March 1, 2012
• Start date: April 2012
• Est. completion date: March 2013

Study information

• Verified date: March 2012
• Source: St. Joseph's Healthcare Hamilton
• Contact: Gamal Seif, MD
• Phone: 9054073882
• Email: gamal.seif[@]medportal.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blepharospasm
• Hemifacial Spasm
• Muscle Cramp
• Spasm

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	St Joseph's Hospital Hamilton	Hamilton	Ontario
Canada	Carrot Eye Centre	Mississauga	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Jankovic Rating Scale	a well established scale used in the literature to grade the symptoms of patients with facial spasms disorders.	3 months post Botox injection	No
Secondary	Treatment Duration Cycle	The number of days between the date of Botox injection to the date in which the symptoms have returned back to baseline.	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.	No
Secondary	Blepharospasm Disability Index (BDI)	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.	3 months post Botox injection	No