Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-01-18 @ 4:32 PM
Study NCT ID:
NCT04171258
Status:
COMPLETED
Last Update Posted:
2022-04-22
First Post:
2019-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With 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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-14', 'studyFirstSubmitDate': '2019-06-20', 'studyFirstSubmitQcDate': '2019-11-18', 'lastUpdatePostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of adverse event', 'timeFrame': '12 weeks (during the clinical trial)', 'description': 'To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after investigational product injection.'}, {'measure': 'Change From Baseline in the Total Score of the TWSTRS score.', 'timeFrame': 'Baseline to Week 4 , Week 8, Week 12', 'description': 'The average of the change from baseline in TWSTRS-total score at Weeks 4, 8 and 12 will be determined.\n\nfull name of TWSTRS is Toronto Western Spasmodic Torticollis Rating Scale. The validated assessment scale TWSTRS is consists of 3 sub-scales.\n\n1. severity (0\\~35 points)\n2. pain (0\\~20 points)\n3. disability( 0\\~30 points) Total score ranges from 0 to 85 points.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Dystonia']}, 'descriptionModule': {'briefSummary': 'To determine the efficacy and safety of Botulax® in treatment of cervical dystonia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female of aged over 19 years\n2. Subjects diagnosed with primary cervical dystonia\n\nExclusion Criteria:\n\n1. Subjects who have administered botulinum toxin within 16 weeks at the time of baseline\n2. Pregnant or nursing\n3. Females or males who do not agree on proper contraceptive measure'}, 'identificationModule': {'nctId': 'NCT04171258', 'briefTitle': 'Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hugel'}, 'officialTitle': 'A Multi-center, Double-blind, Randomized, Parallel, Active-controlled, Phase I Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia', 'orgStudyIdInfo': {'id': 'HG-BOTCD-PI-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Botulax®', 'interventionNames': ['Drug: Botulinum toxin type A injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Botox®', 'interventionNames': ['Drug: Botulinum Toxin Type A Injection [Botox]']}], 'interventions': [{'name': 'Botulinum toxin type A injection', 'type': 'DRUG', 'otherNames': ['Botulax®'], 'description': 'Experimental', 'armGroupLabels': ['Botulax®']}, {'name': 'Botulinum Toxin Type A Injection [Botox]', 'type': 'DRUG', 'otherNames': ['Botox®'], 'description': 'Active Comparator', 'armGroupLabels': ['Botox®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hugel', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hugel', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}