Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT05095493
Status:
COMPLETED
Last Update Posted:
2021-10-27
First Post:
2021-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oral Zinc Supplementation to Enhance Botulinum Neurotoxin Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020821', 'term': 'Dystonic Disorders'}], 'ancestors': [{'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019345', 'term': 'Zinc Acetate'}], 'ancestors': [{'id': 'D019342', 'term': 'Acetic Acid'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Pharmacy prepares vials labeled A and B, and reveals code to PI after data lock'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Single site randomized placebo controlled trial, cross-over'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2014-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-26', 'studyFirstSubmitDate': '2021-10-01', 'studyFirstSubmitQcDate': '2021-10-26', 'lastUpdatePostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Global Impression of Change', 'timeFrame': 'End of study, week 48', 'description': 'Patient selects one of three options: My response to BoNT injection with bottle A tablets was overall better than with bottle B tablets; My response to BoNT injection with bottle B tablets was overall better than bottle A tablets; or Neither BoNT injection with bottle A or with bottle B tablets was overall better than the other'}], 'secondaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events', 'timeFrame': 'At study visits 3 and 4, which are 3 months after the BoNT injection cycles with intervention OZS or placebo', 'description': 'Unstructured interview soliciting side-effects in the interval since prior BoNT injection'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dystonia, Focal']}, 'descriptionModule': {'briefSummary': 'Botulinum neurotoxin (BoNT) is injected into muscles for treatment of dystonia. BoNTs are zinc proteases, and their enzymatic effect is reduced in the setting of low zinc. The study hypothesis is that a large enough fraction of unselected dystonia patients receiving BoNT injection have suboptimal zinc concentration in their tissues, and will experience improved response to BoNT if the injection is preceded by oral zinc supplementation (OZS). OZS consists of 50 mg of zinc acetate oral tablet each day for 7 days before injection. This is a double blind placebo controlled cross-over study, randomized order placebo and OZS, in patients at a neurology clinic on stable dose of BoNT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of the PI\n* Age 18-80\n* Male or female\n* With an approved indication for BoNT such as dystonia or hemifacial spasm\n* Have received either two or three BoNT injection cycles within the prior 8 months\n* Prior two injection cycles length differed by no more than 2 weeks\n* Prior two injection cycles used same brand of BoNT and similar dose within 15%\n\nExclusion Criteria:\n\n* Concommitant use of penicillamine or cisplatin'}, 'identificationModule': {'nctId': 'NCT05095493', 'briefTitle': 'Oral Zinc Supplementation to Enhance Botulinum Neurotoxin Response', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Oral Zinc Supplementation to Enhance Effects of Botulinum Neurotoxin Injection: an n of 1 Study', 'orgStudyIdInfo': {'id': 'STU-082021-075'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'zinc, then placebo', 'description': 'Participants first received oral zinc acetate 50 mg tab each day for 7 days before scheduled BoNT injection. 3 months later participants received oral placebo (matching oral zinc) tablet each day for 7 days before scheduled BoNT injection.', 'interventionNames': ['Dietary Supplement: Zinc Acetate', 'Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'placebo, then zinc', 'description': 'Participants first received placebo tablet (matching oral zinc) each day for 7 days before scheduled BoNT injection. 3 months later participants received oral zinc acetate 50 mg tablet each day for 7 days before scheduled BoNT injection.', 'interventionNames': ['Dietary Supplement: Zinc Acetate', 'Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Zinc Acetate', 'type': 'DIETARY_SUPPLEMENT', 'description': '50 mg tablet', 'armGroupLabels': ['placebo, then zinc', 'zinc, then placebo']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Zinc Acetate matched placebo tablet', 'armGroupLabels': ['placebo, then zinc', 'zinc, then placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': "Padraig E O'Suilleabhain, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTSW'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Neurology', 'investigatorFullName': "Padraig O'Suilleabhain", 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}