Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT01313767
Status:
COMPLETED
Last Update Posted:
2019-03-29
First Post:
2011-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
MEDITOXIN® Versus BOTOX® in the Treatment of Post-stroke Spasticity of the Upper Limb Spasticity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'C050008', 'term': '3-deoxyglycero-galacto-nonulosonic acid'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hgpark@medytox.com', 'phone': '82-70-8666-6911', 'title': 'Medytox Inc.', 'organization': 'Clinical Development Team of Medytox Inc.'}, 'certainAgreement': {'otherDetails': 'All the results which arise directly or indirectly from the clinical trial in any form shall be the exclusive property of the sponsor.\n\nPIs and the sponsor will discuss, prior to public release of the results, any draft publication or communication made by the investigator. PIs shall not mention any information for a patent or for any intellectual property rights. The sponsor may use or explit all the results at its own discretion, without any limitation to its property right.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The subjects were observed every visit after signing an Informed consent form (visit 1) until 12 weeks post injection', 'description': 'All AEs reported during the study period were tabulated and AE incidence was determined.', 'eventGroups': [{'id': 'EG000', 'title': 'Meditoxin®', 'description': 'Botulinum toxin type A', 'otherNumAtRisk': 98, 'otherNumAffected': 35, 'seriousNumAtRisk': 98, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Botox®', 'description': 'Botulinum Toxin type A', 'otherNumAtRisk': 98, 'otherNumAffected': 35, 'seriousNumAtRisk': 98, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Consitipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}], 'seriousEvents': [{'term': 'Hepatitis toxic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Intraventricular haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': "Behcet's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(ver. 14.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'MAS(Modified Ashworth Scale) of Wrist Flexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditoxin®', 'description': 'Botulinum toxin type A'}, {'id': 'OG001', 'title': 'Botox®', 'description': 'Botulinum Toxin type A'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.41', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '2.52', 'spread': '0.66', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '1.02', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '0.96', 'spread': '0.64', 'groupId': 'OG001'}]}]}, {'title': 'Change(Week4-Baseline)', 'categories': [{'measurements': [{'value': '-1.39', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '-1.56', 'spread': '0.81', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1347', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.40', 'groupDescription': 'The difference between the two groups was provided with 95% CI. If the upper limit of CI is no greater than 0.45 (non-inferiority margin), the study group was determined not inferior to the control group. Additionally, difference between groups in change from baseline to week 4 in wrist flexor MAS score was compared using two sample t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '90% of the power, 0.45 of non-inferiority margin'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Change from baseline at week 4 for wrist flexor muscle tone as measured on the MAS(Modified Ashworth Scale). The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).', 'unitOfMeasure': 'Scores on a MAS Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Full Analysis Set population which consisted of 94 subjects receiving Meditoxin and 98 subjects for Botox.'}, {'type': 'SECONDARY', 'title': 'MAS(Modified Ashworth Scale) of Wrist Flexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditoxin®', 'description': 'Botulinum toxin type A'}, {'id': 'OG001', 'title': 'Botox®', 'description': 'Botulinum Toxin type A'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.41', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '2.52', 'spread': '0.66', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '1.07', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '1.16', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '1.16', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '1.16', 'spread': '0.66', 'groupId': 'OG001'}]}]}, {'title': 'Change(Week 8 - Baseline)', 'categories': [{'measurements': [{'value': '-1.35', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '-1.48', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Change(Week12 - Baseline)', 'categories': [{'measurements': [{'value': '-1.25', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '-1.36', 'spread': '0.84', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2591', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.07', 'groupDescription': 'Difference between groups in change from baseline to week 8 in wrist flexor MAS score was compared using two sample t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3395', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.09', 'groupDescription': 'Difference between groups in change from baseline to week 12 in wrist flexor MAS score was compared using two sample t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 8 and week 12', 'description': 'Change from baseline at week 8 and 12 for wrist flexor muscle tone as measured on the MAS(Modified Ashworth Scale).\n\nThe Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).', 'unitOfMeasure': 'Scores on a MAS scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Full Analysis Set population which consisted of 94 subjects receiving Meditoxin and 98 Botox.'}, {'type': 'SECONDARY', 'title': 'MAS(Modified Ashworth Score) of Elbow Flexor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditoxin®', 'description': 'Botulinum toxin type A'}, {'id': 'OG001', 'title': 'Botox®', 'description': 'Botulinum Toxin type A'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.33', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '2.18', 'spread': '0.65', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '1.26', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '1.30', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '1.36', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '1.45', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '1.52', 'spread': '0.60', 'groupId': 'OG001'}]}]}, {'title': 'Change(Week 4 - Baseline)', 'categories': [{'measurements': [{'value': '-1.07', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '-0.87', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Change(Week 8 - Baseline)', 'categories': [{'measurements': [{'value': '-0.97', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '-0.77', 'spread': '0.72', 'groupId': 'OG001'}]}]}, {'title': 'Change(Week 12 - Baseline)', 'categories': [{'measurements': [{'value': '-0.88', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '-0.65', 'spread': '0.74', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0675', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.2', 'groupDescription': 'Difference between groups in change from baseline to week 4 in elbow flexor MAS score was compared using two sample t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0605', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.2', 'groupDescription': 'Difference between groups in change from baseline to week 8 in elbow flexor MAS score was compared using two sample t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0429', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.23', 'groupDescription': 'Difference between groups in change from baseline to week 12 in elbow flexor MAS score was compared using two sample t-test.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 4, week 8 and week 12', 'description': 'Change from baseline at week 4, week 8 and 12 for elbow flexor muscle tone as measured on the MAS(Modified Ashworth Scale).\n\nThe Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. 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'OG000', 'title': 'Meditoxin®', 'description': 'Botulinum toxin type A'}, {'id': 'OG001', 'title': 'Botox®', 'description': 'Botulinum Toxin type A'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.09', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '2.13', 'spread': '0.35', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '1.30', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '1.07', 'spread': '0.47', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '1.36', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '1.27', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'Change(Week 4 - Baseline)', 'categories': [{'measurements': [{'value': '-0.70', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '-1.07', 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{'title': 'Moderate', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Insufficient', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9513', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': "Difference between groups in frequency distribution of responders on the Global Assessment at week 12 was compared using Fisher's exact test.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'week 12', 'description': 'Global assessment evaluated by patient or caregiver at week 12 after injection', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Full Analysis Set population which consisted of 94 subjects receiving Meditoxin and 98 Botox.'}, {'type': 'SECONDARY', 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'1.44', 'spread': '1.09', 'groupId': 'OG001'}]}]}, {'title': 'Change(Week 4 - Baseline)', 'categories': [{'measurements': [{'value': '-0.40', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '-0.34', 'spread': '1.10', 'groupId': 'OG001'}]}]}, {'title': 'Change(Week 8 - Baseline)', 'categories': [{'measurements': [{'value': '-0.46', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': '1.09', 'groupId': 'OG001'}]}]}, {'title': 'Change(Week 12 - Baseline)', 'categories': [{'measurements': [{'value': '-0.51', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '1.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8088', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.06', 'groupDescription': 'Difference between groups in change from baseline to week 4 in carer burden scale of cleaning the palm was compared using wilcoxon rank sum test.', 'statisticalMethod': 'Wilcoxon 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It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).', 'unitOfMeasure': 'Score on a Carer Burden Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Full Analysis Set population which consisted of 92 subjects receiving Meditoxin and 98 Botox.'}, {'type': 'SECONDARY', 'title': 'Carer Burden Scale of Cutting the Finger-nails', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditoxin®', 'description': 'Botulinum toxin type A'}, {'id': 'OG001', 'title': 'Botox®', 'description': 'Botulinum Toxin type A'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.08', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '2.22', 'spread': '1.27', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '1.58', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '1.89', 'spread': '1.32', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '1.57', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '1.84', 'spread': '1.37', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '1.59', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '1.81', 'spread': '1.35', 'groupId': 'OG001'}]}]}, {'title': 'Change(Week 4 - Baseline)', 'categories': [{'measurements': [{'value': '-0.47', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '-0.34', 'spread': '1.17', 'groupId': 'OG001'}]}]}, {'title': 'Change(Week 8 - Baseline)', 'categories': [{'measurements': [{'value': '-0.51', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '1.25', 'groupId': 'OG001'}]}]}, {'title': 'Change(Week 12 - Baseline)', 'categories': [{'measurements': [{'value': '-0.49', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '-0.42', 'spread': '1.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9634', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.13', 'groupDescription': 'Difference between groups in change from baseline to week 4 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7302', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.12', 'groupDescription': 'Difference between groups in change from baseline to week 8 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7715', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.07', 'groupDescription': 'Difference between groups in change from baseline to week 12 in carer burden scale of cutting the finger-nails was compared using wilcoxon rank sum test.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 4, week 8 and week 12', 'description': 'The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).', 'unitOfMeasure': 'Scores on a Carer Burden Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Full Analysis Set population which consisted of 92 subjects receiving Meditoxin and 98 Botox.'}, {'type': 'SECONDARY', 'title': 'Carer Burden Scale of Putting Shirts on', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditoxin®', 'description': 'Botulinum toxin type A'}, {'id': 'OG001', 'title': 'Botox®', 'description': 'Botulinum Toxin type A'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.79', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '1.64', 'spread': '1.11', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '1.46', 'spread': '0.97', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '1.10', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '1.34', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '1.28', 'spread': '0.97', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '1.32', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '1.30', 'spread': '1.07', 'groupId': 'OG001'}]}]}, {'title': 'Change(Week 4 - Baseline)', 'categories': [{'measurements': [{'value': '-0.32', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '0.98', 'groupId': 'OG001'}]}]}, {'title': 'Change(Week 8 - Baseline)', 'categories': [{'measurements': [{'value': '-0.46', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '-0.37', 'spread': '1.17', 'groupId': 'OG001'}]}]}, {'title': 'Change(Week 12 - Baseline)', 'categories': [{'measurements': [{'value': '-0.48', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '1.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9362', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.10', 'groupDescription': 'Difference between groups in change from baseline to week 4 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7998', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.09', 'groupDescription': 'Difference between groups in change from baseline to week 8 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5436', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.13', 'groupDescription': 'Difference between groups in change from baseline to week 12 in carer burden scale of putting shirts on was compared using wilcoxon rank sum test.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 4, week 8 and week 12', 'description': 'The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).', 'unitOfMeasure': 'Scores on a Carer Burden Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Full Analysis Set population which consisted of 92 subjects receiving Meditoxin and 98 Botox.'}, {'type': 'SECONDARY', 'title': 'Carer Burden Scale of Cleaning the Armpit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Meditoxin®', 'description': 'Botulinum toxin type A'}, {'id': 'OG001', 'title': 'Botox®', 'description': 'Botulinum Toxin type A'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.98', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '1.27', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '1.56', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '1.71', 'spread': '1.26', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '1.50', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '1.59', 'spread': '1.29', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '1.42', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '1.69', 'spread': '1.33', 'groupId': 'OG001'}]}]}, {'title': 'Change(Week 4 - Baseline)', 'categories': [{'measurements': [{'value': '-0.39', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '-0.26', 'spread': '1.20', 'groupId': 'OG001'}]}]}, {'title': 'Change(Week 8 - Baseline)', 'categories': [{'measurements': [{'value': '-0.48', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '1.26', 'groupId': 'OG001'}]}]}, {'title': 'Change(Week 12 - Baseline)', 'categories': [{'measurements': [{'value': '-0.55', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': '1.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.13', 'groupDescription': 'Difference between groups in change from baseline to week 4 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.8884', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.10', 'groupDescription': 'Difference between groups in change from baseline to week 8 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2840', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.27', 'groupDescription': 'Difference between groups in change from baseline to week 12 in carer burden scale of cleaning the armpit was compared using wilcoxon rank sum test.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 4, week 8 and week 12', 'description': 'The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).', 'unitOfMeasure': 'Scores on a Carer Burden Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Full Analysis Set population which consisted of 92 subjects receiving Meditoxin and 98 Botox.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Meditoxin®', 'description': 'Clostridium Botulinum toxin type A, up to total 360U injected into selected sites, Intra-muscle'}, {'id': 'FG001', 'title': 'Botox®', 'description': 'Clostridium Botulinum toxin type A, up to total 360U injected into selected sites, Intra-muscle'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '96'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'In this study, total 208 patients were screened and total 196 subjects (98 subjects per group) were randomized, except 12 screening-failures, at 5 study sites.', 'preAssignmentDetails': 'Total 9 subjects were prematurely discontinued from the study due to unmet inclusion/exclusion criteria found after randomization, AEs/SAEs, consent withdrawal and follow-up lost: 7 subjects in study group (7.14%) and 2 subjects in control group (2.04%). Thus total 187 subjects (91 in study group; 96 in control group) completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Meditoxin®', 'description': 'Botulinum toxin type A'}, {'id': 'BG001', 'title': 'Botox®', 'description': 'Botulinum Toxin type A'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.54', 'spread': '11.03', 'groupId': 'BG000'}, {'value': '56.99', 'spread': '13.01', 'groupId': 'BG001'}, {'value': '57.26', 'spread': '12.05', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '65.51', 'spread': '10.27', 'groupId': 'BG000'}, {'value': '62.94', 'spread': '9.67', 'groupId': 'BG001'}, {'value': '64.18', 'spread': '10.02', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'FAS'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-26', 'studyFirstSubmitDate': '2011-03-10', 'resultsFirstSubmitDate': '2015-01-27', 'studyFirstSubmitQcDate': '2011-03-10', 'lastUpdatePostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-26', 'studyFirstPostDateStruct': {'date': '2011-03-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MAS(Modified Ashworth Scale) of Wrist Flexor', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Change from baseline at week 4 for wrist flexor muscle tone as measured on the MAS(Modified Ashworth Scale). The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).'}], 'secondaryOutcomes': [{'measure': 'MAS(Modified Ashworth Scale) of Wrist Flexor', 'timeFrame': 'Baseline, week 8 and week 12', 'description': 'Change from baseline at week 8 and 12 for wrist flexor muscle tone as measured on the MAS(Modified Ashworth Scale).\n\nThe Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).'}, {'measure': 'MAS(Modified Ashworth Score) of Elbow Flexor', 'timeFrame': 'Baseline, week 4, week 8 and week 12', 'description': 'Change from baseline at week 4, week 8 and 12 for elbow flexor muscle tone as measured on the MAS(Modified Ashworth Scale).\n\nThe Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).'}, {'measure': 'MAS(Modified Ashworth Score) of Finger Flexor', 'timeFrame': 'Baseline, week 4, week 8 and week 12', 'description': 'Change from baseline at week 4, week 8 and 12 for finger flexor muscle tone as measured on the MAS(Modified Ashworth Scale).\n\nThe Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).'}, {'measure': 'MAS(Modified Ashworth Score) of Thumb Flexor', 'timeFrame': 'Baseline, week 4, week 8 and week 12', 'description': 'Change from baseline at week 4, 8, 12 for thumb flexor muscle tone as measured on MAS.\n\nThe Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).'}, {'measure': 'Improvement Rate on the MAS(Modified Ashworth Score) of Wrist Flexor', 'timeFrame': 'week 4, week 8, week 12', 'description': 'Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of wrist flexor.\n\n\\* A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site.'}, {'measure': 'Improvement Rate on the MAS(Modified Ashworth Score) of Elbow Flexor', 'timeFrame': 'week 4, week 8, week 12', 'description': 'Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of elbow flexor.\n\n\\* A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site'}, {'measure': 'Improvement Rate on the MAS(Modified Ashworth Score) of Finger Flexor', 'timeFrame': 'week 4, week 8, week 12', 'description': 'Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of finger flexor.\n\n\\* A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site.'}, {'measure': 'Improvement Rate on the MAS(Modified Ashworth Score) of Thumb Flexor', 'timeFrame': 'week 4, week 8, week 12', 'description': 'Improvement in the injected site muscle tone at week 4, 8 and 12 as measured by MAS(Modified Ashworth Score) of thumb flexor.\n\n\\* A treatment response is defined as 1-point improvement on the MAS(Modified Ashworth Score) of injection site.'}, {'measure': 'DAS(Disability Assessment Scale) of Hygiene', 'timeFrame': 'Baseline, week 4, week 8 and week 12', 'description': 'Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target as Hygiene.\n\nThe Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).'}, {'measure': 'DAS(Disability Assessment Scale) of Dressing', 'timeFrame': 'Baseline, week 4, week 8 and week 12', 'description': 'Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target as Dressing. The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).'}, {'measure': 'DAS(Disability Assessment Scale) of Limb Position', 'timeFrame': 'Baseline, week 4, week 8 and week 12', 'description': 'Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target as Limb Position.\n\nThe Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).'}, {'measure': 'DAS(Disability Assessment Scale) of Pain', 'timeFrame': 'Baseline, week 4, week 8 and week 12', 'description': 'Change From Baseline to week 4, 8, 12 in the DAS(Disability Assessment Scale) for the Principal Therapeutic Target as Pain.\n\nThe Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).'}, {'measure': 'Global Assessment by Investigator', 'timeFrame': 'week 12', 'description': 'Global assessment evaluated by investigator at week 12 after injection'}, {'measure': 'Global Assessment by Patient or Caregiver', 'timeFrame': 'week 12', 'description': 'Global assessment evaluated by patient or caregiver at week 12 after injection'}, {'measure': 'Carer Burden Scale of Cleaning the Palm', 'timeFrame': 'Baseline, week 4, week 8 and week 12', 'description': 'The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).'}, {'measure': 'Carer Burden Scale of Cutting the Finger-nails', 'timeFrame': 'Baseline, week 4, week 8 and week 12', 'description': 'The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).'}, {'measure': 'Carer Burden Scale of Putting Shirts on', 'timeFrame': 'Baseline, week 4, week 8 and week 12', 'description': 'The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).'}, {'measure': 'Carer Burden Scale of Cleaning the Armpit', 'timeFrame': 'Baseline, week 4, week 8 and week 12', 'description': 'The Carer Burden Scale evaluates the impact of antispastic medication on the physical burden of the carer. It was assessed on a 5-point Likert scale which values ranges from 0 (=no difficulty) to 4 (=cannot do the task).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['spasticity', 'upperlimb', 'Botulinum toxin'], 'conditions': ['Spasticity']}, 'referencesModule': {'references': [{'pmid': '26030192', 'type': 'DERIVED', 'citation': 'Seo HG, Paik NJ, Lee SU, Oh BM, Chun MH, Kwon BS, Bang MS. Neuronox versus BOTOX in the Treatment of Post-Stroke Upper Limb Spasticity: A Multicenter Randomized Controlled Trial. PLoS One. 2015 Jun 1;10(6):e0128633. doi: 10.1371/journal.pone.0128633. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'This study is a randomized, double blind, multi-center, active drug controlled, phase III clinical trial to compare the efficacy and safety of MEDITOXIN® versus BOTOX® in treatment of post stroke upper limb(wrist, finger, thumb) spasticity\n\nApproximately 196 subjects(1:1 group ratio)will be enrolled. Subjects will receive a single treatment of intramuscular Investigational product up to 360U. The subjects will be observed every 4 weeks until 12 weeks post injection. Outcome measures include Modified Ashworth Scale (MAS), Disability Assessment Scale (DAS), Global Assessment Scale(patient or caregiver/investigator) and Carer burden scale. The primary efficacy endpoint is the change from baseline at week 4 for wrist flexor muscle tone as measured on the Modified Ashworth Scale. Safety parameters will also be measured including adverse events, vital signs and clinical laboratory tests (haematology, serum chemistry and urinanalysis).', 'detailedDescription': 'Each completed subject will attend 4\\~5 clinic visits. The maximum study duration is 15 weeks. Only one upper limb (eligible inclusion/exclusion criteria) will be injected and evaluated in the study. Maximun injection dose is 360U.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female patients ≥ 20 years\n2. ≥ 6 weeks since the last stroke\n3. ≥ 2 points in the focal spasticity of wrist flexor and ≥ 1 points at least one of elbow flexor and finger flexor as measured on MAS(0 to 4)\n4. Targeted one functional disability item (i.e., hygiene, dressing, pain, or cosmesis) with a rating of 2 or greater on DAS (0 to 3)\n5. Informed consent has been obtained.\n\nExclusion Criteria:\n\n1. Neuromuscular disorders such as Lambert-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis\n2. History(within 6 months of screening visit) or planned(during study period) treatment with phenol or alcohol injection or surgery in the target limb\n3. History(within 6 months of screening visit) or planned(during study period) treatment with tendon lengthening in the target limb\n4. Fixed joint/muscle contracture\n5. Severe atrophy\n6. Concurrent treatment with an intrathecal baclofen\n7. History(within 3 months of screening visit) Planned(during study period) treatment with Botulinum Toxin\n8. Known allergy or sensitivity to study medication or its components\n9. Concurrent or planed Muscle relaxants and/or benzodiazepine medication\n\n * 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.\n10. Current Physical, occupational, Splinting therapy\n\n * If these therapy regimens will be permitted if they has been stable in the one month before screening;no treatment and no changes are planned during the study.\n11. Patient who are participating in other clinical trials at the screening\n12. Females who are pregnant, breatfeeding,or planning a pregnancy during the study period, or female of childbearing potential, not using a reliable means of centraception.\n13. Patients who are not eligible for this study at the discretion of the investigator.'}, 'identificationModule': {'nctId': 'NCT01313767', 'briefTitle': 'MEDITOXIN® Versus BOTOX® in the Treatment of Post-stroke Spasticity of the Upper Limb Spasticity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medy-Tox'}, 'officialTitle': 'A Randomized, Double Blind, Multi-center, Active Drug Controlled Clinical Trial to Compare the Efficacy and Safety of MEDITOXIN® Versus BOTOX® in Treatment of Post Stroke Upper Limb Spasticity', 'orgStudyIdInfo': {'id': 'MT-PRT-ST01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meditoxin®', 'description': 'Botulinum toxin type A', 'interventionNames': ['Drug: Botulinum toxin type A']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Botox®', 'description': 'Botulinum Toxin type A', 'interventionNames': ['Drug: Botulinum Toxin type A']}], 'interventions': [{'name': 'Botulinum toxin type A', 'type': 'DRUG', 'otherNames': ['Neuronox®, Siax®'], 'description': 'Botulinum toxin type A', 'armGroupLabels': ['Meditoxin®']}, {'name': 'Botulinum Toxin type A', 'type': 'DRUG', 'otherNames': ['Botox®'], 'description': 'Botulinum Toxin type A', 'armGroupLabels': ['Botox®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Moon Suk Bang, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National Universtiy Hospital, 101 Daehak-ro Jong-gu, Seoul 110-744, Korea'}, {'name': 'Min Ho Chun, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center, 388-1 Pungnap-2 dong, Songpa-Gu, Seoul, 138-736, Korea'}, {'name': 'Nam Jong Baik, Ph. D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Bundang Hospital, Seoul National Univ. Bundang Hospital, Gumi-dong, Bundang-gu, Seongnam-si, Gyeonggi-do, Korea'}, {'name': 'Si Uk Lee, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SMG-SNU Boramae Medical Center, 41, Borame-Gill, Dong Gjak-Gu, Seoul, 156-707, Seoul, Korea'}, {'name': 'Beom Seon Gwon, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dongguk University International Hospital, Siksa-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medy-Tox', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}