Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-01-22 @ 3:08 PM
Study NCT ID:
NCT02757404
Status:
COMPLETED
Last Update Posted:
2019-03-29
First Post:
2016-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Meditoxin® Treatment in Patients With Post Stroke Upper Limb Spasticity
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2016-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-27', 'studyFirstSubmitDate': '2016-04-25', 'studyFirstSubmitQcDate': '2016-04-29', 'lastUpdatePostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison evaluation on improvement rate of spasticity assessed by Modified Ashworth Scale between 3 arms.', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Comparison evaluation on improvement rate of spasticity assessed by Modified Tardieu Scale between 3 arms.', 'timeFrame': '4 weeks'}, {'measure': 'Comparison evaluation on improvement rate of range of motion on each joint between 3 arms.', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['botulinum toxin', 'spasticity', 'injection technique', 'neuronox', 'meditoxin'], 'conditions': ['Muscle Spasticity']}, 'descriptionModule': {'briefSummary': 'Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity.', 'detailedDescription': 'This study is "A Multicenter, Prospective, Randomized, Evaluator Blinded, Comparing Phase 4 Study to Evaluate the Impact of Injection Techniques on the Effectiveness of Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female subject aged over 20.\n2. Subjects who has grade 1 + and more spasticity at least one of upper limb muscles as measured on Modified Ashworth Scale after stroke.\n3. Subjects who was diagnosed stroke at least 1 month prior to study participation.\n4. Subjects or legal representatives who voluntarily decided the participation of the study and signed the informed consent.\n\nExclusion Criteria:\n\n1. Subjects who had spinal injuries to be a factor of spasticity except for stroke prior to study enrollment.\n2. Subjects with allergy or hypersensitivity to the Botulinum Toxin.\n3. Subjects who have changed the muscle relaxant taking for treatment within past 4 weeks prior to study participation.\n4. Subjects who have taken injection treatments using alcohol or phenol in upper limb within past 6 months prior to study participation.\n5. Subjects with general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis).\n6. Subjects who have been injected with botulinum toxin within past 3 months before the injection.\n7. Subjects who are pregnant or lactating of disagreed to avoid pregnancy during 3 months study period.\n8. Subjects who are scheduled to take part in other clinical trial during the study period.\n9. Patients who are not eligible for this study at the medical discretion of the investigator.'}, 'identificationModule': {'nctId': 'NCT02757404', 'briefTitle': 'Meditoxin® Treatment in Patients With Post Stroke Upper Limb Spasticity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medy-Tox'}, 'officialTitle': 'Impact of Injection Techniques on the Effectiveness of Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity', 'orgStudyIdInfo': {'id': 'MT_PRT_ST04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasonography guidance', 'description': 'Ultrasonography guidance injection of Meditoxin®.', 'interventionNames': ['Drug: Ultrasonography guidance injection of Meditoxin®.']}, {'type': 'EXPERIMENTAL', 'label': 'Electrical stimulation guidance', 'description': 'Electrical stimulation guidance injection of Meditoxin®.', 'interventionNames': ['Drug: Electrical stimulation guidance injection of Meditoxin®.']}, {'type': 'EXPERIMENTAL', 'label': 'Manual needle placement', 'description': 'Manual needle placement injection of Meditoxin®.', 'interventionNames': ['Drug: Manual needle placement injection of Meditoxin®.']}], 'interventions': [{'name': 'Ultrasonography guidance injection of Meditoxin®.', 'type': 'DRUG', 'description': 'Meditoxin® will be injected to upper limb spasticity by using the ultrasonography guidance.', 'armGroupLabels': ['Ultrasonography guidance']}, {'name': 'Electrical stimulation guidance injection of Meditoxin®.', 'type': 'DRUG', 'description': 'Meditoxin® will be injected to upper limb spasticity by using the electrical stimulation guidance.', 'armGroupLabels': ['Electrical stimulation guidance']}, {'name': 'Manual needle placement injection of Meditoxin®.', 'type': 'DRUG', 'description': 'Meditoxin® will be injected to upper limb spasticity by using the manual needle placement.', 'armGroupLabels': ['Manual needle placement']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MyungEun Chung', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Paul's Hospital, The Catholic University of Korea"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medy-Tox', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}