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

History of Changes

Purpose

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

Condition	Intervention
Blepharospasm Hemifacial Spasm	Drug: Zinc Supplement Drug: Sugar pill


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	The Effect of Zinc Supplementation on the Efficacy and Duration of Botulinum Toxin for the Treatment of Oculofacial Spasm Disorders

Resource links provided by NLM:

Genetics Home Reference related topics: benign essential blepharospasm

MedlinePlus related topics: Muscle Cramps

Genetic and Rare Diseases Information Center resources: Blepharospasm

U.S. FDA Resources

Further study details as provided by St. Joseph's Healthcare Hamilton:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.


Estimated Enrollment:	40
Study Start Date:	April 2012
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	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.
Experimental: Zinc Group	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.

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546805

Contacts


Contact: Gamal Seif, MD	9054073882	gamal.seif@medportal.ca
Contact: John Harvey, MD	905-573-4848	jtharvey@mcmaster.ca

Locations


Canada, Ontario
St Joseph's Hospital Hamilton	Not yet recruiting
Hamilton, Ontario, Canada, L8N4A6
Contact: Gamal Seif, MD 9054073882 gamal.seif@medportal.ca
Principal Investigator: John Harvey, MD
Carrot Eye Centre	Not yet recruiting
Mississauga, Ontario, Canada, L5J 2Y2
Contact: Yasser Khan, MD 905-822-2020
Principal Investigator: Yasser Khan, MD

Sponsors and Collaborators

St. Joseph's Healthcare Hamilton

Investigators


Principal Investigator:	John Harvey, MD	St Joseph's Hospital Hamilton
Principal Investigator:	Yasser Khan, MD	McMaster University

More Information


Responsible Party:	St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:	NCT01546805 History of Changes
Other Study ID Numbers:	R.P. #11-3601
Study First Received:	February 16, 2012
Last Updated:	March 1, 2012
Health Authority:	Canada: Ethics Review Committee

Keywords provided by St. Joseph's Healthcare Hamilton:


Blepharospasm Hemifacial spasm Botox Zinc

Additional relevant MeSH terms:


Blepharospasm Spasm Muscle Cramp Hemifacial Spasm Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Muscular Diseases Musculoskeletal Diseases Eyelid Diseases Eye Diseases Mouth Diseases	Stomatognathic Diseases Botulinum Toxins Zinc Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Trace Elements Micronutrients Growth Substances

ClinicalTrials.gov processed this record on September 23, 2016

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