Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-31 @ 9:58 AM
Study NCT ID:
NCT01259557
Status:
COMPLETED
Last Update Posted:
2012-04-25
First Post:
2010-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C535428', 'term': 'Benign essential blepharospasm'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-24', 'studyFirstSubmitDate': '2010-11-25', 'studyFirstSubmitQcDate': '2010-12-12', 'lastUpdatePostDateStruct': {'date': '2012-04-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the change rate of Jankovic Rating Scale score', 'timeFrame': '4weeks', 'description': 'To evaluate the change of JRS(Jankovic Rating Scale) score at 4 weeks post treatment based on baseline( 0 week).'}], 'secondaryOutcomes': [{'measure': 'the change rate of Jankovic Rating Scale scale', 'timeFrame': '0 week, 16weeks(or retreatment point)', 'description': 'To evaluate the change of JRS(Jankovic Rating Scale) at retreatment point or 16 weeks post treatment based on Baseline(0 week).'}, {'measure': 'the change rate of Blepharospasm Disability Index', 'timeFrame': '0week, 4weeks, 8weeks, 16weeks(or retreatment point)', 'description': 'To evaluate the change of Blepharospasm Disalbility Index at 4weeks, 8weeks, 16weeks(or retreatment point) post treatment.'}, {'measure': 'Global assessment about the improvement', 'timeFrame': '4weeks', 'description': 'To evaluate the Global assessment about the improvement at 4weeks post treatment.'}, {'measure': 'the duration of efficacy', 'timeFrame': 'retreatment point or 16 weeks', 'description': 'To evaluate the duration of efficacy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Essential Blepharospasm']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the treatment of Essential blepharospasm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged above 18\n* Subjects who was diagnosed with Essential Blepharospasm\n* Subjects who voluntarily Signed written informed consent\n* Subjects who can adhere to protocol and study requirements\n\nExclusion Criteria:\n\n* Subjects with known history of allergy considered due to Botulinum toxin type A\n* Subjects who have received botulinum toxin A type within 3 months\n* Any disease that might affect neuromuscular function (e.g.. Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis ect.)\n* Subjects who are participating in other clinical trials\n* Pregnant or lactating female Subjects\n* Subjects who are not eligible for the study at the discretion of the Investigator.'}, 'identificationModule': {'nctId': 'NCT01259557', 'briefTitle': 'Efficacy and Safety Study of Meditoxin® to Treat Essential Blepharospasm', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medy-Tox'}, 'officialTitle': 'Multi-center, Phase Ⅳ, Single Arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Meditoxin® in Subjects With Essential Blepharospasm', 'orgStudyIdInfo': {'id': 'MT-PRT-BP02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Botulinum toxin type A(Meditoxin®)', 'interventionNames': ['Drug: Botulinum Toxin Type A']}], 'interventions': [{'name': 'Botulinum Toxin Type A', 'type': 'DRUG', 'otherNames': ['Meditoxin', 'Neuronox'], 'description': '2 times, Intra-muscular injection, Maximum dosage total 60U', 'armGroupLabels': ['Botulinum toxin type A(Meditoxin®)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Sevrance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '137-040', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul St.Mary Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '140-883', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Chung-Ang Univesity Yongsan Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jaechan Kim, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chung-Ang university Yongsan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medy-Tox', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Yujin Sun / CRA', 'oldOrganization': 'Medytox'}}}}