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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01546805
Other study ID # R.P. #11-3601
Secondary ID
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


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
See also
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Terminated NCT03263000 - Photic Blink Reflex in People With Blepharospasm and Increased Blinking
Completed NCT03938363 - Analysis of Gait Before and After Botulinum Toxin Treatment in Patients With Focal Dystonia N/A
Completed NCT02947815 - Safety and Efficacy of NABOTA in Treatment of Essential Blepharospasm Phase 2/Phase 3
Completed NCT00406367 - IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Blepharospasm Phase 3
Completed NCT00682760 - Comparison of Korean Botulinum Toxin Type A Versus Botox in the Treatment of Essential Blepharospasm Phase 3
Completed NCT00210431 - Post Marketing Surveillance Study of Dysport
Completed NCT05103202 - Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum Toxin
Completed NCT04423341 - Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm Phase 2/Phase 3
Completed NCT03269123 - A Mechanical Device for Blepharospasm N/A
Completed NCT00411255 - Brain Stimulation to Treat Blepharospasm or Meige Syndrome Phase 2
Completed NCT00500799 - Brain Changes in Blepharospasm N/A
Completed NCT00761592 - Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm Phase 4
Completed NCT00001784 - Mexiletine for the Treatment of Focal Dystonia Phase 2
Recruiting NCT04939909 - Botulinum Toxin Relieves Anxiety, Depression and Sleep Disorderes in Patients With Blepharospasm Early Phase 1
Completed NCT03508882 - Pretarsal Versus Preseptal Botulinum Toxin for Patients With Eyelid Spasm Phase 4
Completed NCT01814774 - A Retrospective Chart Review of BOTOX® and Xeomin® for the Treatment of Cervical Dystonia and Blepharospasm N/A
Completed NCT00234507 - Study of a Single Administration of 3 Doses of Dysport® for the Treatment of Benign Essential Blepharospasm Phase 2