Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-02 @ 9:48 PM
Study NCT ID:
NCT02230956
Status:
COMPLETED
Last Update Posted:
2017-05-31
First Post:
2014-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'D000077330', 'term': 'Saline Solution'}], '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'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area Head,', 'organization': 'Allergan, Inc'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Day 172', 'eventGroups': [{'id': 'EG000', 'title': 'OnabotulinumtoxinA 400 U', 'description': 'OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.', 'otherNumAtRisk': 44, 'otherNumAffected': 9, 'seriousNumAtRisk': 44, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'OnabotulinumtoxinA 200 U', 'description': 'OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.', 'otherNumAtRisk': 43, 'otherNumAffected': 15, 'seriousNumAtRisk': 43, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.', 'otherNumAtRisk': 89, 'otherNumAffected': 26, 'seriousNumAtRisk': 89, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Basal ganglia infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Incision site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OnabotulinumtoxinA 400 U', 'description': 'OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA 200 U', 'description': 'OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.92', 'spread': '1.222', 'groupId': 'OG000'}, {'value': '6.09', 'spread': '1.313', 'groupId': 'OG001'}, {'value': '6.00', 'spread': '1.150', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 8', 'categories': [{'measurements': [{'value': '-1.68', 'spread': '1.641', 'groupId': 'OG000'}, {'value': '-2.07', 'spread': '1.602', 'groupId': 'OG001'}, {'value': '-1.98', 'spread': '1.793', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OnabotulinumtoxinA 400 U', 'description': 'OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA 200 U', 'description': 'OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.84', 'spread': '1.629', 'groupId': 'OG000'}, {'value': '5.41', 'spread': '1.806', 'groupId': 'OG001'}, {'value': '5.34', 'spread': '1.548', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.75', 'spread': '1.567', 'groupId': 'OG000'}, {'value': '-1.61', 'spread': '1.666', 'groupId': 'OG001'}, {'value': '-1.62', 'spread': '1.805', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.82', 'spread': '1.893', 'groupId': 'OG000'}, {'value': '-1.67', 'spread': '1.763', 'groupId': 'OG001'}, {'value': '-1.81', 'spread': '1.848', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.02', 'spread': '1.899', 'groupId': 'OG000'}, {'value': '-1.52', 'spread': '1.907', 'groupId': 'OG001'}, {'value': '-1.76', 'spread': '1.976', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.81', 'spread': '1.975', 'groupId': 'OG000'}, {'value': '-1.82', 'spread': '1.870', 'groupId': 'OG001'}, {'value': '-1.75', 'spread': '2.014', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.67', 'spread': '1.841', 'groupId': 'OG000'}, {'value': '-1.64', 'spread': '2.174', 'groupId': 'OG001'}, {'value': '-1.62', 'spread': '1.901', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.79', 'spread': '1.937', 'groupId': 'OG000'}, {'value': '-1.68', 'spread': '2.066', 'groupId': 'OG001'}, {'value': '-1.78', 'spread': '2.037', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.93', 'spread': '2.289', 'groupId': 'OG000'}, {'value': '-1.81', 'spread': '2.181', 'groupId': 'OG001'}, {'value': '-1.69', 'spread': '2.008', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24', 'description': 'The WOMAC Pain Score consisted of 5 questions about pain completed by the participant where: 0=no pain to 10=extreme pain for a total possible Pain Score of 0 (best) to 50 (worst). A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received. "n" in the category is the number of participants with data available at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OnabotulinumtoxinA 400 U', 'description': 'OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA 200 U', 'description': 'OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.56', 'spread': '1.804', 'groupId': 'OG000'}, {'value': '5.35', 'spread': '1.995', 'groupId': 'OG001'}, {'value': '4.99', 'spread': '1.854', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.33', 'spread': '1.424', 'groupId': 'OG000'}, {'value': '-1.64', 'spread': '1.870', 'groupId': 'OG001'}, {'value': '-1.44', 'spread': '1.933', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.26', 'spread': '1.672', 'groupId': 'OG000'}, {'value': '-1.66', 'spread': '1.908', 'groupId': 'OG001'}, {'value': '-1.35', 'spread': '2.069', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.54', 'spread': '1.819', 'groupId': 'OG000'}, {'value': '-1.50', 'spread': '2.043', 'groupId': 'OG001'}, {'value': '-1.27', 'spread': '2.070', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.30', 'spread': '1.648', 'groupId': 'OG000'}, {'value': '-1.68', 'spread': '1.781', 'groupId': 'OG001'}, {'value': '-1.40', 'spread': '2.170', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.29', 'spread': '1.558', 'groupId': 'OG000'}, {'value': '-1.59', 'spread': '2.127', 'groupId': 'OG001'}, {'value': '-1.09', 'spread': '1.991', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.34', 'spread': '1.651', 'groupId': 'OG000'}, {'value': '-1.44', 'spread': '2.172', 'groupId': 'OG001'}, {'value': '-1.18', 'spread': '2.087', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.48', 'spread': '2.029', 'groupId': 'OG000'}, {'value': '-1.56', 'spread': '2.232', 'groupId': 'OG001'}, {'value': '-1.12', 'spread': '1.998', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24', 'description': 'The WOMAC Physical Function Score consisted of 17 questions about the difficulty of daily activities completed by the participant where: 0=no difficulty to 10=extreme difficulty for a total possible Physical Function Score of 0 (best) to 170 (worst). A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received. "n" in the category is the number of participants with data available at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Change (GIC) Using a 7-Point Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OnabotulinumtoxinA 400 U', 'description': 'OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.'}, {'id': 'OG001', 'title': 'OnabotulinumtoxinA 200 U', 'description': 'OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.97', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '1.09', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.23', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '1.10', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.35', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.00', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.30', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.14', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.36', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.10', 'groupId': 'OG002'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.42', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.20', 'groupId': 'OG002'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.28', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1, 4, 8, 12, 16, 20 and 24', 'description': 'The participant rated the change in their health status since enrollment using a 7-point scale where: +3=very much improved, +2=much improved, +1=minimally improved, 0=no change, -1=minimally worse, -2=much worse and -3=very much worse. 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A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OnabotulinumtoxinA 400 U', 'description': 'OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.'}, {'id': 'FG001', 'title': 'OnabotulinumtoxinA 200 U', 'description': 'OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '89'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '82'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Personal Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other Miscellaneous Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '176', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'OnabotulinumtoxinA 400 U', 'description': 'OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.'}, {'id': 'BG001', 'title': 'OnabotulinumtoxinA 200 U', 'description': 'OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.7', 'spread': '8.25', 'groupId': 'BG000'}, {'value': '60.2', 'spread': '8.41', 'groupId': 'BG001'}, {'value': '61.1', 'spread': '7.79', 'groupId': 'BG002'}, {'value': '60.8', 'spread': '8.02', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 176}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-05', 'studyFirstSubmitDate': '2014-08-29', 'resultsFirstSubmitDate': '2017-03-08', 'studyFirstSubmitQcDate': '2014-08-29', 'lastUpdatePostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-08', 'studyFirstPostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale', 'timeFrame': 'Baseline, Week 8', 'description': 'Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale', 'timeFrame': 'Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24', 'description': 'The WOMAC Pain Score consisted of 5 questions about pain completed by the participant where: 0=no pain to 10=extreme pain for a total possible Pain Score of 0 (best) to 50 (worst). A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale', 'timeFrame': 'Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24', 'description': 'The WOMAC Physical Function Score consisted of 17 questions about the difficulty of daily activities completed by the participant where: 0=no difficulty to 10=extreme difficulty for a total possible Physical Function Score of 0 (best) to 170 (worst). A negative change from Baseline indicates improvement.'}, {'measure': 'Patient Global Impression of Change (GIC) Using a 7-Point Scale', 'timeFrame': 'Weeks 1, 4, 8, 12, 16, 20 and 24', 'description': 'The participant rated the change in their health status since enrollment using a 7-point scale where: +3=very much improved, +2=much improved, +1=minimally improved, 0=no change, -1=minimally worse, -2=much worse and -3=very much worse. Negative scores indicate worsening and positive scores indicate improvement.'}, {'measure': 'Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale', 'timeFrame': 'Baseline, Week 24', 'description': 'Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily worst pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '29753118', 'type': 'DERIVED', 'citation': 'McAlindon TE, Schmidt U, Bugarin D, Abrams S, Geib T, DeGryse RE, Kim K, Schnitzer TJ. Efficacy and safety of single-dose onabotulinumtoxinA in the treatment of symptoms of osteoarthritis of the knee: results of a placebo-controlled, double-blind study. Osteoarthritis Cartilage. 2018 Oct;26(10):1291-1299. doi: 10.1016/j.joca.2018.05.001. Epub 2018 May 9.'}], 'seeAlsoLinks': [{'url': 'http://www.allerganclinicaltrials.com', 'label': 'More Information'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of a single intra-articular injection of 2 doses of BOTOX® (onabotulinumtoxinA) compared with placebo as treatment for knee osteoarthritis symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Painful osteoarthritis\n* Able to discontinue anti-inflammatory drugs and analgesics\n* Must be ambulatory without assistive walking devices\n\nExclusion Criteria:\n\n* Chronic pain conditions other than knee osteoarthritis\n* Treatment with corticosteroids in the study knee within 12 weeks\n* Treatment with hyaluronic acid in the study knee within 24 weeks\n* Previous treatment with any botulinum toxin for any reason\n* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis'}, 'identificationModule': {'nctId': 'NCT02230956', 'briefTitle': 'BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis', 'orgStudyIdInfo': {'id': '191622-145'}, 'secondaryIdInfos': [{'id': '2014-001076-58', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OnabotulinumtoxinA 400 U', 'description': 'OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.', 'interventionNames': ['Biological: onabotulinumtoxinA']}, {'type': 'EXPERIMENTAL', 'label': 'OnabotulinumtoxinA 200 U', 'description': 'OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.', 'interventionNames': ['Biological: onabotulinumtoxinA']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'onabotulinumtoxinA', 'type': 'BIOLOGICAL', 'otherNames': ['botulinum toxin Type A', 'BOTOX®'], 'description': 'onabotulinumtoxinA (botulinum toxin Type A) injection into the intra-articular space of the study knee.', 'armGroupLabels': ['OnabotulinumtoxinA 200 U', 'OnabotulinumtoxinA 400 U']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': 'Normal Saline (placebo) injection into the intra-articular space of the study knee.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Artesia', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.86585, 'lon': -118.08312}}, {'city': 'Pardubice', 'country': 'Czechia', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'city': 'Vejle', 'country': 'Denmark', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}