Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-30 @ 12:55 AM
Study NCT ID:
NCT05164003
Status:
COMPLETED
Last Update Posted:
2022-01-11
First Post:
2021-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CORETOX® in Treatment of Post Stroke Upper Limb Spasticity (Phase1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009128', 'term': 'Muscle Spasticity'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000710873', 'term': 'coretox'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-21', 'studyFirstSubmitDate': '2021-12-05', 'studyFirstSubmitQcDate': '2021-12-05', 'lastUpdatePostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Ashworth Scale of wrist flexor', 'timeFrame': '4 weeks', 'description': 'Change from baseline at week 4 for wrist flexor muscle tone as measured on the MAS (Modified Ashworth Scale) Minimum value: 0 (best outcome) Maximum value: 4 (worst outcome)'}], 'secondaryOutcomes': [{'measure': 'Modified Ashworth Scale of elbow and finger flexor', 'timeFrame': '4 weeks after the injection', 'description': 'Change from baseline at week 4 for elbow flexor and finger flexor muscle tone as measured on MAS Minimum value: 0 (best outcome) Maximum value: 4 (worst outcome)'}, {'measure': 'Modified Ashworth Scale of wrist, elbow and finger flexor', 'timeFrame': '8 and 12 weeks after the injection', 'description': 'Change from baseline at week 8, 12 for wrist flexor, elbow flexor and finger flexor muscle tone as measured on MAS Minimum value: 0 (best outcome) Maximum value: 4 (worst outcome)'}, {'measure': 'Modified Ashworth Scale of wrist, elbow and finger flexor', 'timeFrame': '4, 8 and 12 weeks after the injection', 'description': 'The responder rate of wrist, elbow, and finger flexor tone at week 4, 8 and 12 if the responder rate is defined as at least 1-point decrease in MAS score after IP administration.\n\nMinimum value: 0 (best outcome) Maximum value: 4 (worst outcome)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Muscle Spasticity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and pharmacodynamic of CORETOX® in the treatment of post-stroke upper limb spasticity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients ≥ 19 years\n\n * 6 months since the last stroke\n * 2 points in the focal spasticity of wrist flexor and ≥ 1 point at least one of elbow flexor and finger flexor as measured on MAS(0 to 4)\n* Informed consent has been obtained\n\nExclusion Criteria:\n\n* Neuromuscular disorders such as Lambert-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis\n* History(within 4 months of screening visit) or planned(during study period) treatment with phenol or alcohol injection or surgery in the target limb\n* History(within 4 months of screening visit) or planned(during study period) treatment with tendon lengthening in the target limb\n* Fixed joint/muscle contracture\n* Severe atrophy\n* Concurrent treatment with an intrathecal baclofen\n* Patients who have bleeding tendency or taking anti-coagulant\n* Dysphagia and Breathing Difficulties\n* History(within 4 months of screening visit) Planned(during study period) treatment with Botulinum Toxin\n* Known allergy or sensitivity to study medication or its components\n* Concurrent or planed Muscle relaxants and/or benzodiazepine medication If patient has taken these medication stable from one month before screening and no treatment changes are not planned during the study, participation is allowed.\n* Current Physical, occupational, Splinting therapy These therapy regimens will be permitted if they have been stable in the one month before screening; no treatment and no changes are planned during the study.\n* Patient who are participating in other clinical trials at the screening\n* Females who are pregnant, breastfeeding, or planning a pregnancy during the study period, or female of childbearing potential, not using a reliable means of contraception.\n* Patients who are not eligible for this study at the discretion of the investigator.'}, 'identificationModule': {'nctId': 'NCT05164003', 'briefTitle': 'CORETOX® in Treatment of Post Stroke Upper Limb Spasticity (Phase1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medy-Tox'}, 'officialTitle': 'A Randomized, Double-blind, Active Drug Controlled, Multi-Center, Phase I/III Clinical Trial to Evaluate the Efficacy and Safety of CORETOX® in Treatment of Post Stroke Upper Limb Spasticity', 'orgStudyIdInfo': {'id': 'MT03-KR16MST907 (Phase1)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CORETOX®', 'interventionNames': ['Drug: CORETOX®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BOTOX®', 'interventionNames': ['Drug: BOTOX®']}], 'interventions': [{'name': 'CORETOX®', 'type': 'DRUG', 'description': 'Up to a total of 360U of the IP was allowed to be injected at three flexors; wrist, elbow and finger.', 'armGroupLabels': ['CORETOX®']}, {'name': 'BOTOX®', 'type': 'DRUG', 'description': 'Up to a total of 360U of the comparator was allowed to be injected at three flexors; wrist, elbow and finger.', 'armGroupLabels': ['BOTOX®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medy-Tox', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}