Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-02-22 @ 11:38 PM
Study NCT ID:
NCT02245958
Status:
COMPLETED
Last Update Posted:
2016-01-08
First Post:
2014-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective Chart Review of BOTOX® and Xeomin® for the Management of Cervical Dystonia and Blepharospasm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014103', 'term': 'Torticollis'}, {'id': 'D001764', 'term': 'Blepharospasm'}], 'ancestors': [{'id': 'D004421', 'term': 'Dystonia'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-06', 'studyFirstSubmitDate': '2014-09-18', 'studyFirstSubmitQcDate': '2014-09-18', 'lastUpdatePostDateStruct': {'date': '2016-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose of Botulinum Toxin Used to Treat Cervical Dystonia', 'timeFrame': '4 Years'}, {'measure': 'Dose of Botulinum Toxin Used to Treat Blepharospasm', 'timeFrame': '4 Years'}], 'secondaryOutcomes': [{'measure': 'Botulinum Toxin Inter-injection Intervals', 'timeFrame': '4 Years'}, {'measure': 'Number of Participants with Adverse Events', 'timeFrame': '4 Years'}, {'measure': 'Annual Botulinum Toxin Dose per Patient', 'timeFrame': '4 Years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cervical Dystonia', 'Blepharospasm']}, 'descriptionModule': {'briefSummary': 'This study is a retrospective chart review to evaluate the doses of botulinum Type A toxins BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used for the treatment of Cervical Dystonia and Blepharospasm in clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with cervical dystonia or blepharospasm previously treated with Xeomin® and BOTOX® in clinical practice.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed primary diagnosis of idiopathic cervical dystonia or blepharospasm for at least 2 years\n* Treatment with Xeomin® and BOTOX® for at least 2 years each.\n\nExclusion Criteria:\n\n* Having a neuromuscular junction transmission disorder or taking any medications that could affect neuromuscular junction transmission\n* Previous surgical procedure involving bone or muscle for the management of cervical dystonia or blepharospasm.'}, 'identificationModule': {'nctId': 'NCT02245958', 'briefTitle': 'A Retrospective Chart Review of BOTOX® and Xeomin® for the Management of Cervical Dystonia and Blepharospasm', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'GMA-US-NEU-0271'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BOTOX®', 'description': 'Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.', 'interventionNames': ['Other: No Intervention']}, {'label': 'Xeomin®', 'description': 'Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'No treatment (intervention) was administered.', 'armGroupLabels': ['BOTOX®', 'Xeomin®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06700', 'city': 'Colonia Roma Z.P.', 'country': 'Mexico'}, {'zip': 'WF1 4DG', 'city': 'Wakefield', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.68331, 'lon': -1.49768}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}