Testing the Effect of Zinc Supplementation to Improve the Treatment Effect of Botulinum Toxin for Oculofacial Spasm
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|ClinicalTrials.gov Identifier: NCT01546805|
Recruitment Status : Unknown
Verified March 2012 by St. Joseph's Healthcare Hamilton.
Recruitment status was: Not yet recruiting
First Posted : March 7, 2012
Last Update Posted : March 7, 2012
|Condition or disease||Intervention/treatment||Phase|
|Blepharospasm Hemifacial Spasm||Drug: Zinc Supplement Drug: Sugar pill||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Zinc Supplementation on the Efficacy and Duration of Botulinum Toxin for the Treatment of Oculofacial Spasm Disorders|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||March 2013|
|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.
- Jankovic Rating Scale [ Time Frame: 3 months post Botox injection ]a well established scale used in the literature to grade the symptoms of patients with facial spasms disorders.
- 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. ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01546805
|Contact: Gamal Seif, MDfirstname.lastname@example.org|
|Contact: John Harvey, MDemail@example.com|
|St Joseph's Hospital Hamilton||Not yet recruiting|
|Hamilton, Ontario, Canada, L8N4A6|
|Contact: Gamal Seif, MD 9054073882 firstname.lastname@example.org|
|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|
|Principal Investigator:||John Harvey, MD||St Joseph's Hospital Hamilton|
|Principal Investigator:||Yasser Khan, MD||McMaster University|