Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-02-03 @ 5:36 AM
Study NCT ID:
NCT03232320
Status:
COMPLETED
Last Update Posted:
2019-03-27
First Post:
2017-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Meditoxin® Treatment in Patients With Cervical Dystonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004421', 'term': 'Dystonia'}, {'id': 'D020821', 'term': 'Dystonic Disorders'}], 'ancestors': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, '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': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-25', 'studyFirstSubmitDate': '2017-07-25', 'studyFirstSubmitQcDate': '2017-07-25', 'lastUpdatePostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline', 'timeFrame': 'week 4 follow-up visit'}], 'secondaryOutcomes': [{'measure': 'Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a change From Baseline', 'timeFrame': 'week 4 follow-up visit'}, {'measure': 'Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale as a change From Baseline', 'timeFrame': 'week 4 follow-up visit'}, {'measure': 'Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale as a change From Baseline', 'timeFrame': 'week 4 follow-up visit'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dystonia', 'Dystonic Disorder']}, 'descriptionModule': {'briefSummary': 'To determine the efficacy and safety of Meditoxin in subjects with cervical dystonia compared with placebo (normal saline)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 20 to less than 75 years\n* Subjects requiring treatment for a clinical diagnosis of cervical dystonia with Toronto Western Spasmodic Torticollis Rating Scale(TWSTRS)-Total Score \\>=20 and TWSTRS-Severity score \\>=10\n\nExclusion Criteria:\n\n* Subjects with pure anterocollis\n* Subjects with neuromuscular junctional disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome)\n* A history of an anaphylactic response to Botulinum toxin type A and other involved ingredients of Investigational product\n* Subjects of reproductive age who do not agree to use suitable contraceptive methods for the duration of the study'}, 'identificationModule': {'nctId': 'NCT03232320', 'briefTitle': 'Meditoxin® Treatment in Patients With Cervical Dystonia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medy-Tox'}, 'officialTitle': 'A Prospective, Randomized, Multi-center, Phase III, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of MEDITOXIN in Treatment of Cervical Dystonia', 'orgStudyIdInfo': {'id': 'MT01-KR16CVD309'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MEDITOXIN', 'interventionNames': ['Drug: Meditoxin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Meditoxin', 'type': 'DRUG', 'description': 'Meditoxin (Botulinum toxin type A)', 'armGroupLabels': ['MEDITOXIN']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo (Normal saline)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medy-Tox', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}