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
Recruitment status was Not yet recruiting
Sponsor:
St. Joseph's Healthcare Hamilton
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
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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:
Dietary Supplements
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 |
| 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
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
No publications provided
| 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 Hemifacial Spasm Spasm Eye Diseases Eyelid Diseases Mouth Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Signs and Symptoms Stomatognathic Diseases |
Botulinum Toxins Zinc Anti-Dyskinesia Agents Central Nervous System Agents Growth Substances Micronutrients Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses Trace Elements |
ClinicalTrials.gov processed this record on February 26, 2015