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