Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2026-03-03 @ 10:06 AM
Study NCT ID:
NCT01603628
Status:
COMPLETED
Last Update Posted:
2018-08-14
First Post:
2012-05-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BOTOX® Treatment in Pediatric Lower Limb Spasticity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009128', 'term': 'Muscle Spasticity'}, {'id': 'D002547', 'term': 'Cerebral Palsy'}], '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'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System 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'}, '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': 'Baseline (Day 1) to the end of study (Week 12)', 'description': 'The Safety Population, all treated participants based on the treatment received, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.', 'eventGroups': [{'id': 'EG000', 'title': 'BOTOX® 8 U/kg', 'description': 'Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 8 U per kg of body weight (8 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly physical therapy (PT).', 'otherNumAtRisk': 128, 'deathsNumAtRisk': 128, 'otherNumAffected': 24, 'seriousNumAtRisk': 128, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BOTOX® 4 U/kg', 'description': 'Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 U per kg of body weight (4 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly PT.', 'otherNumAtRisk': 126, 'deathsNumAtRisk': 126, 'otherNumAffected': 26, 'seriousNumAtRisk': 126, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb. Participants received weekly PT.', 'otherNumAtRisk': 128, 'deathsNumAtRisk': 128, 'otherNumAffected': 35, 'seriousNumAtRisk': 128, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastoeneteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Radicular Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Tonsillar hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Ankle Score With Knee Extended at Weeks 4 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BOTOX® 8 U/kg', 'description': 'Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 8 U per kg of body weight (8 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly physical therapy (PT).'}, {'id': 'OG001', 'title': 'BOTOX® 4 U/kg', 'description': 'Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 U per kg of body weight (4 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly PT.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb. Participants received weekly PT.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.06', 'spread': '0.071', 'groupId': 'OG000'}, {'value': '-1.01', 'spread': '0.072', 'groupId': 'OG001'}, {'value': '-0.80', 'spread': '0.071', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.010', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.453', 'ciUpperLimit': '-0.063', 'pValueComment': 'MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.033', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.405', 'ciUpperLimit': '-0.018', 'pValueComment': 'MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) to Weeks 4 and 6', 'description': 'The MAS-B was used to evaluate spasticity based on grading the resistance encountered in the principal muscle group (elbow and wrist) by means of passively moving a limb through its range of motion at a study specified velocity. The resistance encountered to passive stretch was graded using a 6-point scale where: 0=no increase in muscle tone (best) to 4=affected part(s) rigid in flexion or extension (worst). For analysis purposes, the MAS-B was recoded as follows: 0=1, 1=1, 1+=2, 2=3, 3=4, 4=5. The scores at Weeks 4 and 6 were averaged. A Mixed Model Repeated Measures (MMRM) model was used for analysis. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the mITT population, all randomized participants with a valid MAS-B baseline ankle score with knee extended and at least one post-baseline measurement at Weeks 2, 4, or 6 for the MAS-B of the ankle score with knee extended and the CGI by physician, with data available for analysis.'}, {'type': 'PRIMARY', 'title': 'Average Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BOTOX® 8 U/kg', 'description': 'Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 8 U per kg of body weight (8 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly physical therapy (PT).'}, {'id': 'OG001', 'title': 'BOTOX® 4 U/kg', 'description': 'Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 U per kg of body weight (4 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly PT.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb. Participants received weekly PT.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.65', 'spread': '0.090', 'groupId': 'OG000'}, {'value': '1.49', 'spread': '0.091', 'groupId': 'OG001'}, {'value': '1.36', 'spread': '0.089', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.023', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '0.040', 'ciUpperLimit': '0.532', 'pValueComment': 'MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.299', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.115', 'ciUpperLimit': '0.374', 'pValueComment': 'MMRM including baseline MAS-B ankle score (knee extended) as a covariate and factors of age, treatment, visit, treatment-by-visit interaction, study center and previous botulinum toxin exposure where age is represented by stratification categories.', 'statisticalMethod': 'Mixed Model Repeated Measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 4 and 6', 'description': "The CGI of overall change (improvement or worsening) was assessed by the physician considering the participant's clinical condition and severity of side effects using a 9-point scale where: -4=very marked worsening to +4=very marked improvement. The scores at Weeks 4 and 6 were averaged. A Mixed Model Repeated Measures (MMRM) model was used for analysis.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the mITT population, all randomized participants with a valid MAS-B baseline ankle score with knee extended and at least one post-baseline measurement at Weeks 2, 4, or 6 for the MAS-B of the ankle score with knee extended and the CGI by physician, with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BOTOX® 8 U/kg', 'description': 'Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 8 U per kg of body weight (8 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly physical therapy (PT).'}, {'id': 'OG001', 'title': 'BOTOX® 4 U/kg', 'description': 'Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 U per kg of body weight (4 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly PT.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb. Participants received weekly PT.'}], 'classes': [{'title': 'Week 8, Active Goal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.108', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.108', 'groupId': 'OG001'}, {'value': '-0.31', 'spread': '0.105', 'groupId': 'OG002'}]}]}, {'title': 'Week 8, Passive Goal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.115', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.114', 'groupId': 'OG001'}, {'value': '-0.26', 'spread': '0.111', 'groupId': 'OG002'}]}]}, {'title': 'Week 12, Active Goal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.112', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.113', 'groupId': 'OG001'}, {'value': '-0.12', 'spread': '0.111', 'groupId': 'OG002'}]}]}, {'title': 'Week 12, Passive Goal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.114', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '0.114', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.112', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.41', 'ciLowerLimit': '0.126', 'ciUpperLimit': '0.704', 'pValueComment': 'ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.', 'groupDescription': 'Week 8, Active Goal', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.047', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '0.004', 'ciUpperLimit': '0.573', 'pValueComment': 'ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.', 'groupDescription': 'Week 8, Active Goal', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '0.145', 'ciUpperLimit': '0.756', 'pValueComment': 'ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.', 'groupDescription': 'Week 8, Passive Goal', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.004', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.44', 'ciLowerLimit': '0.141', 'ciUpperLimit': '0.740', 'pValueComment': 'ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.', 'groupDescription': 'Week 8, Passive Goal', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.49', 'ciLowerLimit': '0.191', 'ciUpperLimit': '0.797', 'pValueComment': 'ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.', 'groupDescription': 'Week 12, Active Goal', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.153', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '-0.081', 'ciUpperLimit': '0.541', 'pValueComment': 'ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.', 'groupDescription': 'Week 12, Active Goal', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.41', 'ciLowerLimit': '0.100', 'ciUpperLimit': '0.711', 'pValueComment': 'ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.', 'groupDescription': 'Week 12, Passive Goal', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.078', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-0.031', 'ciUpperLimit': '0.571', 'pValueComment': 'ANCOVA model including baseline MAS-B ankle score with knee extended as a covariate and factors of age group, treatment group, study center and previous botulinum toxin exposure where age group is represented by stratification categories.', 'groupDescription': 'Week 12, Passive Goal', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 8 and 12', 'description': 'Two functional goals, one active and one passive, were selected by the participant and family in consultation with the physician investigator and/or treating physical therapist relative to the lower limb impairment due to spasticity. The physician assessed the achievement of the goals using a 6-point scale: where -3=worse than start to +2=much more than expected: improvements clearly exceed the defined therapeutic goal. An Analysis of Covariance (ANCOVA) model was used for analysis.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the mITT population, all randomized participants with a valid MAS-B baseline ankle score with knee extended and at least one post-baseline measurement at Weeks 2, 4, or 6 for the MAS-B of the ankle score with knee extended and the CGI by physician, with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Severity of Spasticity of the Ankle With Knee Extended and Knee Flexed (R2-R1) Calculated Using the Modified Tardieu Scale (MTS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BOTOX® 8 U/kg', 'description': 'Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 8 U per kg of body weight (8 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly physical therapy (PT).'}, {'id': 'OG001', 'title': 'BOTOX® 4 U/kg', 'description': 'Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 U per kg of body weight (4 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly PT.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb. Participants received weekly PT.'}], 'classes': [{'title': 'Change from Baseline to Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.44', 'spread': '1.023', 'groupId': 'OG000'}, {'value': '-5.69', 'spread': '1.024', 'groupId': 'OG001'}, {'value': '-2.44', 'spread': '1.0101', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.11', 'spread': '1.134', 'groupId': 'OG000'}, {'value': '-6.80', 'spread': '1.135', 'groupId': 'OG001'}, {'value': '-4.69', 'spread': '1.121', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.65', 'spread': '1.029', 'groupId': 'OG000'}, {'value': '-7.23', 'spread': '1.049', 'groupId': 'OG001'}, {'value': '-3.32', 'spread': '1.029', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.42', 'spread': '1.317', 'groupId': 'OG000'}, {'value': '-5.82', 'spread': '1.308', 'groupId': 'OG001'}, {'value': '-3.36', 'spread': '1.291', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.59', 'spread': '1.070', 'groupId': 'OG000'}, {'value': '-3.07', 'spread': '1.074', 'groupId': 'OG001'}, {'value': '-1.98', 'spread': '1.057', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.158', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.99', 'ciLowerLimit': '-4.768', 'ciUpperLimit': '0.779', 'pValueComment': 'ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.', 'groupDescription': 'Change from Baseline to Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.020', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.25', 'ciLowerLimit': '-5.974', 'ciUpperLimit': '-0.524', 'pValueComment': 'ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.', 'groupDescription': 'Change from Baseline to Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.363', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.42', 'ciLowerLimit': '-4.489', 'ciUpperLimit': '1.648', 'pValueComment': 'ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.', 'groupDescription': 'Change from Baseline to Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.171', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.11', 'ciLowerLimit': '-5.127', 'ciUpperLimit': '0.914', 'pValueComment': 'ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.', 'groupDescription': 'Change from Baseline to Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.020', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.33', 'ciLowerLimit': '-6.143', 'ciUpperLimit': '-0.525', 'pValueComment': 'ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.', 'groupDescription': 'Change from Baseline to Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.006', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.92', 'ciLowerLimit': '-6.688', 'ciUpperLimit': '-1.148', 'pValueComment': 'ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.', 'groupDescription': 'Change from Baseline to Week 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.254', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.07', 'ciLowerLimit': '-5.621', 'ciUpperLimit': '1.491', 'pValueComment': 'ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.', 'groupDescription': 'Change from Baseline to Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.165', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.46', 'ciLowerLimit': '-5.935', 'ciUpperLimit': '1.014', 'pValueComment': 'ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.', 'groupDescription': 'Change from Baseline to Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.078', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.61', 'ciLowerLimit': '-5.517', 'ciUpperLimit': '0.296', 'pValueComment': 'ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.', 'groupDescription': 'Change from Baseline to Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.451', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.09', 'ciLowerLimit': '-3.944', 'ciUpperLimit': '1.758', 'pValueComment': 'ANCOVA model including baseline MTS ankle score with knee extended as a covariate and factors of age group, treatment group, study center, and previous botulinum toxin exposure where age group is represented by stratification categories.', 'groupDescription': 'Change from Baseline to Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) to Weeks 2, 4, 6, 8 and 12', 'description': 'The MTS measured the difference between slow and fast range of motion (R2-R1) and respective change from baseline to each posttreatment office visit. The MTS of the ankle was used to determine the passive range of movement at different movement velocities, V1 (as slow as possible) and V3 (as fast as possible) with the relative difference between a slow and fast velocity passive stretch determining the dynamic component of the muscle contracture for the joint. The investigator measured 2 joint angles by goniometer: the R1 angle which is the angle of catch after a fast velocity (V3) stretch and the R2 angle defined as the passive joint range of movement following a slow velocity (V1) stretch. The R2-R1 value indicated the level of the dynamic component of spasticity in the joint. The difference between R2 and R1 range of motion and respective change from baseline to each posttreatment office visit on the MTS was derived. An Analysis of Covariance (ANCOVA) model was used for analysis.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the mITT population, all randomized participants with a valid MAS-B baseline ankle score with knee extended and at least one post-baseline measurement at Weeks 2, 4, or 6 for the MAS-B of the ankle score with knee extended and the CGI by physician, with data available for analysis at the given time-point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BOTOX® 8 U/kg', 'description': 'Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 8 units (U) per kg of body weight (8 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly physical therapy (PT).'}, {'id': 'FG001', 'title': 'BOTOX® 4 U/kg', 'description': 'Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 U per kg of body weight (4 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly PT.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb. Participants received weekly PT.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '126'}, {'groupId': 'FG002', 'numSubjects': '130'}]}, {'type': 'Safety Population: Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '126'}, {'groupId': 'FG002', 'numSubjects': '128'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '125'}, {'groupId': 'FG001', 'numSubjects': '123'}, {'groupId': 'FG002', 'numSubjects': '128'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Personal Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other Miscellaneous Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Pediatric participants with lower limb spasticity were randomized 1:1:1 to one of three treatment groups: BOTOX® 4 or 8 U/kg (unit per kilogram) or placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '384', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'BOTOX® 8 U/kg', 'description': 'Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 8 U per kg of body weight (8 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly physical therapy (PT).'}, {'id': 'BG001', 'title': 'BOTOX® 4 U/kg', 'description': 'Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 U per kg of body weight (4 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly PT.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb. Participants received weekly PT.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '384', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6.7', 'spread': '3.90', 'groupId': 'BG000'}, {'value': '6.4', 'spread': '3.58', 'groupId': 'BG001'}, {'value': '6.6', 'spread': '3.89', 'groupId': 'BG002'}, {'value': '6.6', 'spread': '3.79', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '384', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '177', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '207', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '384', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '233', 'groupId': 'BG003'}]}]}, {'title': 'Black', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '384', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '384', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '384', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}, {'title': 'Other Not Specified', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '384', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Modified Ashworth Scale-Bohannon (MAS-B) Ankle Score with Knee Extended', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}, {'value': '382', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.52', 'groupId': 'BG000'}, {'value': '3.5', 'spread': '0.53', 'groupId': 'BG001'}, {'value': '3.5', 'spread': '0.50', 'groupId': 'BG002'}, {'value': '3.5', 'spread': '0.52', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The MAS-B evaluates spasticity, grading the resistance encountered in the principal muscle group (elbow and wrist) by passively moving a limb through its range of motion at a specified velocity. The resistance encountered to passive stretch was graded on a 6-point scale: 0=no increase in muscle tone (best) to 4=affected part(s) rigid in flexion or extension (worst). For analysis purposes, the MAS-B was recoded as follows: 0=1, 1=1, 1+=2, 2=3, 3=4, 4=5.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '2 participants in the Placebo arm are not included in the analysis.'}], 'populationDescription': 'All randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-16', 'size': 529484, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-06-12T16:36', 'hasProtocol': False}, {'date': '2016-07-25', 'size': 809187, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-06-12T16:36', 'hasProtocol': True}]}}, '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': 384}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-16', 'studyFirstSubmitDate': '2012-05-21', 'resultsFirstSubmitDate': '2018-06-12', 'studyFirstSubmitQcDate': '2012-05-21', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-16', 'studyFirstPostDateStruct': {'date': '2012-05-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Ankle Score With Knee Extended at Weeks 4 and 6', 'timeFrame': 'Baseline (Day 1) to Weeks 4 and 6', 'description': 'The MAS-B was used to evaluate spasticity based on grading the resistance encountered in the principal muscle group (elbow and wrist) by means of passively moving a limb through its range of motion at a study specified velocity. The resistance encountered to passive stretch was graded using a 6-point scale where: 0=no increase in muscle tone (best) to 4=affected part(s) rigid in flexion or extension (worst). For analysis purposes, the MAS-B was recoded as follows: 0=1, 1=1, 1+=2, 2=3, 3=4, 4=5. The scores at Weeks 4 and 6 were averaged. A Mixed Model Repeated Measures (MMRM) model was used for analysis. A negative change from Baseline indicates improvement.'}, {'measure': 'Average Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 6', 'timeFrame': 'Weeks 4 and 6', 'description': "The CGI of overall change (improvement or worsening) was assessed by the physician considering the participant's clinical condition and severity of side effects using a 9-point scale where: -4=very marked worsening to +4=very marked improvement. The scores at Weeks 4 and 6 were averaged. A Mixed Model Repeated Measures (MMRM) model was used for analysis."}], 'secondaryOutcomes': [{'measure': 'Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale', 'timeFrame': 'Weeks 8 and 12', 'description': 'Two functional goals, one active and one passive, were selected by the participant and family in consultation with the physician investigator and/or treating physical therapist relative to the lower limb impairment due to spasticity. The physician assessed the achievement of the goals using a 6-point scale: where -3=worse than start to +2=much more than expected: improvements clearly exceed the defined therapeutic goal. An Analysis of Covariance (ANCOVA) model was used for analysis.'}, {'measure': 'Change From Baseline in Severity of Spasticity of the Ankle With Knee Extended and Knee Flexed (R2-R1) Calculated Using the Modified Tardieu Scale (MTS)', 'timeFrame': 'Baseline (Day 1) to Weeks 2, 4, 6, 8 and 12', 'description': 'The MTS measured the difference between slow and fast range of motion (R2-R1) and respective change from baseline to each posttreatment office visit. The MTS of the ankle was used to determine the passive range of movement at different movement velocities, V1 (as slow as possible) and V3 (as fast as possible) with the relative difference between a slow and fast velocity passive stretch determining the dynamic component of the muscle contracture for the joint. The investigator measured 2 joint angles by goniometer: the R1 angle which is the angle of catch after a fast velocity (V3) stretch and the R2 angle defined as the passive joint range of movement following a slow velocity (V1) stretch. The R2-R1 value indicated the level of the dynamic component of spasticity in the joint. The difference between R2 and R1 range of motion and respective change from baseline to each posttreatment office visit on the MTS was derived. An Analysis of Covariance (ANCOVA) model was used for analysis.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pediatrics', 'Muscle Spasticity', 'Cerebral Palsy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.allerganclinicaltrials.com', 'label': 'Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with lower limb spasticity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimum weight of 10 kg/22 lb\n* Cerebral palsy with dynamic muscle contracture /spasticity of the ankle\n\nExclusion Criteria:\n\n* Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or mitochondrial disease\n* Uncontrolled epilepsy\n* Botulinum Toxin therapy of any serotype for any condition within the last 6 months\n* History of surgical intervention of the lower study leg or planned surgery of any limb during the study\n* Previous casting of the study limb for spasticity within 6 months or with a dynamic splint within 3 months, or planned casting or dynamic splinting for spasticity of the study limb or affected upper limb during the study'}, 'identificationModule': {'nctId': 'NCT01603628', 'briefTitle': 'BOTOX® Treatment in Pediatric Lower Limb Spasticity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'BOTOX® Treatment in Pediatric Lower Limb Spasticity: Double-blind Study', 'orgStudyIdInfo': {'id': '191622-111'}, 'secondaryIdInfos': [{'id': '2012-000042-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BOTOX® 4 U/kg', 'description': 'Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 U per kg of body weight (4 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly physical therapy (PT).', 'interventionNames': ['Biological: botulinum toxin Type A']}, {'type': 'EXPERIMENTAL', 'label': 'BOTOX® 8 U/kg', 'description': 'Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 8 U per kg of body weight (8 U/kg) into specified muscles of the lower limb on Day 1. Participants received weekly PT.', 'interventionNames': ['Biological: botulinum toxin Type A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal Saline (Placebo)', 'description': 'Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb on Day 1. Participants received weekly PT.', 'interventionNames': ['Drug: Normal Saline (Placebo)']}], 'interventions': [{'name': 'botulinum toxin Type A', 'type': 'BIOLOGICAL', 'otherNames': ['BOTOX®'], 'description': 'Participants received intramuscular injections of botulinum toxin Type A into specified muscles of the lower limb on Day 1.', 'armGroupLabels': ['BOTOX® 4 U/kg', 'BOTOX® 8 U/kg']}, {'name': 'Normal Saline (Placebo)', 'type': 'DRUG', 'description': 'Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb on Day 1.', 'armGroupLabels': ['Normal Saline (Placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91106', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'AMS Neurology', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '91767', 'city': 'Pomona', 'state': 'California', 'country': 'United States', 'facility': 'Harrison Clinical Management', 'geoPoint': {'lat': 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