Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-01-04 @ 4:44 PM
Study NCT ID:
NCT03905304
Status:
COMPLETED
Last Update Posted:
2019-04-08
First Post:
2019-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of MEDITOXIN® in Cervical Dystonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014103', 'term': 'Torticollis'}], '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'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2014-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-05', 'studyFirstSubmitDate': '2019-03-27', 'studyFirstSubmitQcDate': '2019-04-04', 'lastUpdatePostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in TWSTRS score', 'timeFrame': '1 month', 'description': 'Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score after 1 month of administration. The scale consists scores from 0 to 35 which corresponds to disorder severity, 35 being the most severe.'}], 'secondaryOutcomes': [{'measure': 'Safety Analysis of Investigational Product: Number of adverse events occuring during the clinical trial', 'timeFrame': '1, 2, 3 months', 'description': 'Number of adverse events occuring during the clinical trial.'}, {'measure': 'Change in TWSTRS score', 'timeFrame': '1, 2, 3 months', 'description': 'Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score after 1, 2, and 3 month of administration. The scale consists scores from 0 to 35 which corresponds to disorder severity, 35 being the most severe.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CD phase III'], 'conditions': ['Cervical Dystonia']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to test the hypothesis that the efficacy and safety of Meditoxin® are not inferior to Botox®'s in the treatment of Cervical Dystonia.", 'detailedDescription': 'The allocated subject is injected Investigational Product(Meditoxin® or Botox®) 200\\~300U in cervical muscles. The efficacy and safety are evaluated for 12weeks through 4 follow up visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women aged between 20 and 75.\n* Patient who is diagnosed with primary cervical dystonia over 1 year.\n* Patients whose total score is over 20 in TWSTRS and the severity score is over 10 in TWSTRS.\n* For patients with prior treatments of Botox®, over 12 weeks have passed.\n* Patients who voluntarily sign the informed consent\n* Patients who can comply with the study procedures and visit schedule\n\nExclusion Criteria:\n\n* Patient who has been diagnosed with pure anterocollis.\n* Patient who has been diagnosed with neuromuscular disorder(myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, etc.)\\\\\n* Severe respiratory function disorder or dysphasia\n* Allergy in Investigational Product.\n* Pregnant women, breast feeding women and patients disagreeing to use an acceptable contraception method\n* Investigator's decision."}, 'identificationModule': {'nctId': 'NCT03905304', 'acronym': 'CD Phase III', 'briefTitle': 'Efficacy and Safety of MEDITOXIN® in Cervical Dystonia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medy-Tox'}, 'officialTitle': 'A Prospective, Randomized, Multi-center, Phase III, Double-Blind, Activi Controlled, Parallel-group Study to Evaliate the Efficacy and Safety of MEDITOXIN® Comparison With BOTOX® in Treatment of Cervical Dystonia', 'orgStudyIdInfo': {'id': 'MT_PRT_CD01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meditoxin', 'description': 'Meditoxin administered 200U\\~300U, single-dose administration.', 'interventionNames': ['Biological: Medytoxin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Botox', 'description': 'Botox administered 200-300U, single-dose administration.', 'interventionNames': ['Biological: Botox']}], 'interventions': [{'name': 'Medytoxin', 'type': 'BIOLOGICAL', 'otherNames': ['botulinum type A toxin'], 'description': 'Intramuscular injection up to 300U.', 'armGroupLabels': ['Meditoxin']}, {'name': 'Botox', 'type': 'BIOLOGICAL', 'otherNames': ['botulinum type A toxin'], 'description': 'Intramuscular injection up to 300U.', 'armGroupLabels': ['Botox']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medy-Tox', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}