Ignite Creation Date:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2025-12-24 @ 12:39 PM
Study NCT ID:
NCT01686061
Status:
COMPLETED
Last Update Posted:
2022-10-28
First Post:
2012-09-12
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Blepharospasm Patient Survey for Patients With Blepharospasm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001764', 'term': 'Blepharospasm'}], 'ancestors': [{'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-26', 'studyFirstSubmitDate': '2012-09-12', 'studyFirstSubmitQcDate': '2012-09-14', 'lastUpdatePostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Botulinum Toxin Treatment Information', 'timeFrame': 'This is a single, structured interview about experiences with Botulinum Toxins', 'description': "The following information for patients treated for blepharospasm with incobotulinumtoxinA, abobotulinumtoxinA, or onabotulinumtoxinA treatment is collected: (1) botulinum treatment information such as intervals for botulinum injections, physician's rationale for injection interval, overall experience with botulinum toxin injections (onset, maximum effect, decline of effect), current injection cycle experience (current satisfaction, satisfaction at maximum effect, and visual analog scale (VAS) of current health status); and (2) disability status using the Blepharospasm Disability Index (BSDI) and the Jankovic Rating Scale (JRS)"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Blepharospasm']}, 'descriptionModule': {'briefSummary': 'The purpose of this survey is to collect detailed information on patients treated for blepharospasm with incobotulinumtoxinA, abobotulinumtoxinA and onabotulinumtoxinA, including how often they are treated with botulinum toxin, how long their treatment lasts, how satisfied they are with their treatment, and if there is any improvement in their symptoms with the treatment.', 'detailedDescription': 'This study is open to males and females \\> 18 years and \\< 81 years with a clinical diagnosis of blepharospasm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '81 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated for blepharospasm with incobotulinumtoxinA, abobotulinumtoxinA or onabotulinumtoxinA treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subject aged \\> 18 years and \\< 81 years\n* Documented clinical diagnosis of blepharospasm\n* Currently receiving incobotulinumtoxinA, abobotulinumtoxinA or onabotulinumtoxinA\n\nExclusion Criteria:\n\n* Previous treatment with rimabotulinumtoxinB in the last 2 treatment cycles'}, 'identificationModule': {'nctId': 'NCT01686061', 'briefTitle': 'Blepharospasm Patient Survey for Patients With Blepharospasm', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merz Pharmaceuticals GmbH'}, 'officialTitle': 'Blepharospasm Patient Survey: A Structured Interview Evaluating Previous and Current incobotulinumtoxinA, abobotulinumtoxinA and onabotulinumtoxinA Treatment for Patients With Blepharospasm', 'orgStudyIdInfo': {'id': 'MUS6020100920'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Blepharospasm Survey Group', 'interventionNames': ['Other: No intervention- only one time survey']}], 'interventions': [{'name': 'No intervention- only one time survey', 'type': 'OTHER', 'armGroupLabels': ['Blepharospasm Survey Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Merz Investigative Site #0007', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Merz Investigative Site # 0002', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Merz Investigative Site # 0001', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Merz Investigative Site #003', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Merz Investigative Site # 0006', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Micki Seoane', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merz Pharmaceutical, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merz Pharmaceuticals GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merz North America, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}