Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT01546805
Status:
UNKNOWN
Last Update Posted:
2012-03-07
First Post:
2012-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testing the Effect of Zinc Supplementation to Improve the Treatment Effect of Botulinum Toxin for Oculofacial Spasm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001764', 'term': 'Blepharospasm'}, {'id': 'D019569', 'term': 'Hemifacial Spasm'}], 'ancestors': [{'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D013035', 'term': 'Spasm'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-01', 'studyFirstSubmitDate': '2012-02-16', 'studyFirstSubmitQcDate': '2012-03-01', 'lastUpdatePostDateStruct': {'date': '2012-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Jankovic Rating Scale', 'timeFrame': '3 months post Botox injection', 'description': 'a well established scale used in the literature to grade the symptoms of patients with facial spasms disorders.'}], 'secondaryOutcomes': [{'measure': 'Treatment Duration Cycle', 'timeFrame': '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.', 'description': 'The number of days between the date of Botox injection to the date in which the symptoms have returned back to baseline.'}, {'measure': 'Blepharospasm Disability Index (BDI)', 'timeFrame': '3 months post Botox injection', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Blepharospasm', 'Hemifacial spasm', 'Botox', 'Zinc'], 'conditions': ['Blepharospasm', 'Hemifacial Spasm']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether zinc supplements are effective in enhancing the treatment of oculofacial spasm disorders with botulinum toxin.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* greater than the age 18 years old\n* patient with hemifacial spasm\n* patient with benign essential blepharospasm.\n\nExclusion Criteria:\n\n* patients who have received Botox within 3 months time,\n* patients prone to malabsorption (i.e. those with Celiac disease, inflammatory bowel disease, liver disease, laxative use)\n* patients who cannot tolerate zinc supplementation due to kidney disease, gastrointestinal disease, or any other medical condition.'}, 'identificationModule': {'nctId': 'NCT01546805', 'briefTitle': 'Testing the Effect of Zinc Supplementation to Improve the Treatment Effect of Botulinum Toxin for Oculofacial Spasm', 'organization': {'class': 'OTHER', 'fullName': "St. Joseph's Healthcare Hamilton"}, 'officialTitle': 'The Effect of Zinc Supplementation on the Efficacy and Duration of Botulinum Toxin for the Treatment of Oculofacial Spasm Disorders', 'orgStudyIdInfo': {'id': 'R.P. #11-3601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Sugar pill']}, {'type': 'EXPERIMENTAL', 'label': 'Zinc Group', 'interventionNames': ['Drug: Zinc Supplement']}], 'interventions': [{'name': 'Zinc Supplement', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Zinc Group']}, {'name': 'Sugar pill', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8N4A6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Gamal Seif, MD', 'role': 'CONTACT', 'email': 'gamal.seif@medportal.ca', 'phone': '9054073882'}, {'name': 'John Harvey, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St Joseph's Hospital Hamilton", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L5J 2Y2', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Yasser Khan, MD', 'role': 'CONTACT', 'phone': '905-822-2020'}, {'name': 'Yasser Khan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Carrot Eye Centre', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}], 'centralContacts': [{'name': 'Gamal Seif, MD', 'role': 'CONTACT', 'email': 'gamal.seif@medportal.ca', 'phone': '9054073882'}, {'name': 'John Harvey, MD', 'role': 'CONTACT', 'email': 'jtharvey@mcmaster.ca', 'phone': '905-573-4848'}], 'overallOfficials': [{'name': 'John Harvey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St Joseph's Hospital Hamilton"}, {'name': 'Yasser Khan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Joseph's Healthcare Hamilton", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}