Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-02-27 @ 1:09 AM
Study NCT ID:
NCT01518257
Status:
COMPLETED
Last Update Posted:
2014-08-07
First Post:
2012-01-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Botulinum Toxin Type A as Treatment for Osteoarthritis Knee Pain
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 30 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': {'eventGroups': [{'id': 'EG000', 'title': 'Botulinum Toxin Type A', 'description': 'A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.', 'otherNumAtRisk': 61, 'otherNumAffected': 7, 'seriousNumAtRisk': 61, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.', 'otherNumAtRisk': 60, 'otherNumAffected': 14, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'seriousEvents': [{'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A', 'description': 'A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.4', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '1.28', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 4', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '1.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all treated participants based on the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Western Ontario and McMaster Universities Arthritis (WOMAC™) Total Index Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A', 'description': 'A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '104.5', 'spread': '36.53', 'groupId': 'OG000'}, {'value': '107.6', 'spread': '37.44', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 8 (n=59,59)', 'categories': [{'measurements': [{'value': '-46.5', 'spread': '35.21', 'groupId': 'OG000'}, {'value': '-43.8', 'spread': '47.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'The WOMAC Total Index Score consisted of 24 components rated on a scale of 0 to 10. The Total Index Score included the WOMAC Pain Score (5 questions about pain where: 0=no pain to 10=extreme pain), the WOMAC Physical Function score (17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty) and the WOMAC Stiffness Score (2 questions about stiffness where: 0=no stiffness to 10=extreme stiffness) for a total possible Index Score of 0 (best) to 240 (worst). A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all treated participants based on the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in WOMAC Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A', 'description': 'A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '23.9', 'spread': '6.76', 'groupId': 'OG000'}, {'value': '24.3', 'spread': '7.01', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 8 (n=59,59)', 'categories': [{'measurements': [{'value': '-10.7', 'spread': '7.27', 'groupId': 'OG000'}, {'value': '-11.0', 'spread': '9.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'The WOMAC Pain Score included 5 questions about pain where: 0=no pain to 10=extreme pain for a total possible score of 0 (best) to 50 (worst). A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all treated participants based on the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in WOMAC Physical Function Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A', 'description': 'A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '71.0', 'spread': '28.43', 'groupId': 'OG000'}, {'value': '73.3', 'spread': '29.77', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 8 (n=59,59 )', 'categories': [{'measurements': [{'value': '-31.7', 'spread': '26.41', 'groupId': 'OG000'}, {'value': '-28.6', 'spread': '35.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'The WOMAC Physical Function Score included 17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty for a total possible score of 0 (best) to 170 (worst). A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all treated participants based on the actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Change Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A', 'description': 'A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'The participants 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 indicated worsening and positive scores indicated improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Safety population (all treated participants based on the actual treatment received) with data available for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A', 'description': 'A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.4', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '1.28', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 8', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '2.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all treated participants based on the actual treatment received.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A', 'description': 'A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.4', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '1.28', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 12', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '2.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all treated participants based on the actual treatment received.'}, {'type': 'POST_HOC', 'title': 'Change From Baseline in the Average Daily Worst Pain Intensity Score in the Nociceptive Pain Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A', 'description': 'A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.4', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '1.35', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 4', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '1.58', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 8', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '2.01', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 12', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '2.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8 and 12', 'description': 'The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Safety population (all treated participants based on the actual treatment received) in a subgroup of patients with nociceptive pain (pain that is caused by nerves that react to injury or damage) at Baseline.'}, {'type': 'POST_HOC', 'title': 'Change From Baseline in WOMAC Pain Score in the Nociceptive Pain Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A', 'description': 'A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '22.7', 'spread': '5.95', 'groupId': 'OG000'}, {'value': '22.9', 'spread': '6.98', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 8 (n=35,31)', 'categories': [{'measurements': [{'value': '-11.0', 'spread': '7.09', 'groupId': 'OG000'}, {'value': '-7.5', 'spread': '9.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'The WOMAC Pain Score included 5 questions about pain where: 0=no pain to 10=extreme pain for a total possible score of 0 (best) to 50 (worst). A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Safety population (all treated participants based on the actual treatment received) in a subgroup of patients with nociceptive pain (pain that is caused by nerves that react to injury or damage) at Baseline.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Botulinum Toxin Type A', 'description': 'A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other Miscellaneous Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Botulinum Toxin Type A', 'description': 'A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '40 to 64 Years', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}, {'title': '≥ 65 Years', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'dispFirstSubmitDate': '2014-01-27', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-15', 'studyFirstSubmitDate': '2012-01-23', 'dispFirstSubmitQcDate': '2014-01-27', 'resultsFirstSubmitDate': '2014-07-15', 'studyFirstSubmitQcDate': '2012-01-23', 'dispFirstPostDateStruct': {'date': '2014-02-27', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-15', 'studyFirstPostDateStruct': {'date': '2012-01-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 4', 'timeFrame': 'Baseline, Week 4', 'description': 'The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.'}, {'measure': 'Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 8', 'timeFrame': 'Baseline, Week 8', 'description': 'The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.'}, {'measure': 'Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Western Ontario and McMaster Universities Arthritis (WOMAC™) Total Index Score', 'timeFrame': 'Baseline, Week 8', 'description': 'The WOMAC Total Index Score consisted of 24 components rated on a scale of 0 to 10. The Total Index Score included the WOMAC Pain Score (5 questions about pain where: 0=no pain to 10=extreme pain), the WOMAC Physical Function score (17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty) and the WOMAC Stiffness Score (2 questions about stiffness where: 0=no stiffness to 10=extreme stiffness) for a total possible Index Score of 0 (best) to 240 (worst). A negative change from Baseline indicated improvement.'}, {'measure': 'Change From Baseline in WOMAC Pain Score', 'timeFrame': 'Baseline, Week 8', 'description': 'The WOMAC Pain Score included 5 questions about pain where: 0=no pain to 10=extreme pain for a total possible score of 0 (best) to 50 (worst). A negative change from Baseline indicated improvement.'}, {'measure': 'Change From Baseline in WOMAC Physical Function Score', 'timeFrame': 'Baseline, Week 8', 'description': 'The WOMAC Physical Function Score included 17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty for a total possible score of 0 (best) to 170 (worst). A negative change from Baseline indicated improvement.'}, {'measure': 'Patient Global Impression of Change Score', 'timeFrame': 'Week 8', 'description': 'The participants 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 indicated worsening and positive scores indicated improvement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of a single intra-articular (IA) injection of botulinum toxin Type A compared with placebo as treatment for osteoarthritis (OA) knee pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Painful osteoarthritis in the study knee\n* Able to walk without assistive walking devices, able to perform usual daily activities, and agree to maintain similar activity level throughout the study\n\nExclusion Criteria:\n\n* Chronic pain conditions other than knee osteoarthritis\n* Presence of bursitis, meniscus tear, ligament tear, or significant injury to the study knee within 1 year\n* Surgery to the study knee within 24 weeks\n* Treatment with hyaluronic acid in the study knee within 24 weeks\n* Treatment with corticosteroids in the study knee within 12 weeks\n* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis\n* Previous treatment with botulinum toxin of any serotype for any reason'}, 'identificationModule': {'nctId': 'NCT01518257', 'briefTitle': 'Safety and Efficacy Study of Botulinum Toxin Type A as Treatment for Osteoarthritis Knee Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': '191622-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'botulinum toxin Type A', 'description': 'A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.', 'interventionNames': ['Biological: botulinum toxin Type A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'botulinum toxin Type A', 'type': 'BIOLOGICAL', 'otherNames': ['BOTOX®'], 'description': 'A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.', 'armGroupLabels': ['botulinum toxin Type A']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': 'A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aalborg', 'country': 'Denmark', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}