Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-30 @ 12:48 PM
Study NCT ID:
NCT01249404
Status:
COMPLETED
Last Update Posted:
2022-09-28
First Post:
2010-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dysport® Adult Lower Limb Spasticity Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'C542869', 'term': 'abobotulinumtoxinA'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical.trials@ipsen.com', 'title': 'Medical Director, Neurology', 'organization': 'Ipsen'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From baseline up to Week 24 +/- 2 weeks.', 'description': 'Adverse event (AE) data is reported as treatment emergent AEs; an AE was reported as emergent if it arose (i.e. started or worsened in severity) after the subject received study medication and were monitored from the time that the subject gave informed consent to the end of the study. All AEs were elicited by direct, non-leading questioning or by spontaneous reports. The safety population consisted of all randomised subjects who received at least 1 injection of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received intramuscular (i.m.) injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).', 'otherNumAtRisk': 127, 'otherNumAffected': 22, 'seriousNumAtRisk': 127, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).', 'otherNumAtRisk': 128, 'otherNumAffected': 21, 'seriousNumAtRisk': 128, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.', 'otherNumAtRisk': 130, 'otherNumAffected': 11, 'seriousNumAtRisk': 130, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pulmonary embolism', 'notes': 'Death (in placebo subject)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Loss of consciousness', 'notes': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Femur Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Least Squares Mean Change From Baseline to Week 4 in the MAS Score in the Gastrocnemius-soleus Complex (GSC) (Knee Extended)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '-0.5'}, {'value': '-0.8', 'groupId': 'OG001', 'lowerLimit': '-0.9', 'upperLimit': '-0.7'}, {'value': '-0.5', 'groupId': 'OG002', 'lowerLimit': '-0.7', 'upperLimit': '-0.4'}]}]}], 'analyses': [{'pValue': '=0.2859', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least squares (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.1', 'estimateComment': 'LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.', 'groupDescription': 'The least squares mean change from baseline to Week 4 for MAS in the Dysport® 1000 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect analysis of covariance (ANCOVA) model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '=0.0091', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '-0.1', 'estimateComment': 'LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.', 'groupDescription': 'The least squares mean change from baseline to Week 4 for MAS in the Dysport® 1500 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 1, 4 and 12, at discretionary visits at Weeks 16, 20 and 24, and at end of study. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM)), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. The least squares mean change from baseline at Week 4 is reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4.'}, {'type': 'SECONDARY', 'title': "Physician's Global Assesment (PGA) of Treatment Response at Week 4", 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '1.1'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '1.1'}, {'value': '0.7', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '0.9'}]}]}], 'analyses': [{'pValue': '=0.0640', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.0', 'ciUpperLimit': '0.5', 'estimateComment': 'LS means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on visit results with treatment, BTX treatment status at baseline and centre as covariates.', 'groupDescription': 'The mean PGA at Week 4 in the Dysport® 1000 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '=0.0665', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.0', 'ciUpperLimit': '0.5', 'estimateComment': 'LS means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on visit results with treatment, BTX treatment status at baseline and centre as covariates.', 'groupDescription': 'The mean PGA at Week 4 in the Dysport® 1500 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0466', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.2', 'estimateComment': 'LS means for each treatment group and treatment comparisons and the p-values are obtained from an analysis of variance on visit results based on ranked values with treatment, BTX treatment status at baseline and centre as explanatory variables.', 'groupDescription': 'The LS mean rank values were back transformed to the original scale to give ranked PGA scores in an attempt to better normalise the data and restore power.', 'statisticalMethod': 'ANCOVA on rank PGA scores', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0406', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.2', 'estimateComment': 'LS means for each treatment group and treatment comparisons and the p-values are obtained from an analysis of variance on visit results based on ranked values with treatment, BTX treatment status at baseline and centre as explanatory variables.', 'groupDescription': 'The LS mean rank values were back transformed to the original scale to give ranked PGA scores in an attempt to better normalise the data and restore power.', 'statisticalMethod': 'ANCOVA on rank PGA scores', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At Week 4', 'description': "An assessment of overall treatment response was conducted at Weeks 4 and 12, and discretionary visits at Weeks 16, 20 and 24 and at end of study by an investigator who had not assessed the MAS. The investigator rated the response to treatment in the subject's lower limb after injection of Dysport® relative to the status at the baseline. Answers were made on a 9 point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. The mean PGA score at Week 4 is reported.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data at Week 4 are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Least Squares Mean Change From Baseline to Week 4 in Comfortable Barefoot Walking Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '0.07'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.06'}, {'value': '0.05', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.07'}]}]}], 'analyses': [{'pValue': '=0.7247', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.03', 'estimateComment': 'LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.', 'groupDescription': 'The least squares mean change from baseline to Week 4 for barefoot comfortable walking speed in the Dysport® 1000 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect analysis of covariance (ANCOVA) model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '=0.7266', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.02', 'estimateComment': 'LS Means for each treatment group and treatment comparisons as well as the p-values are obtained from an ANCOVA on the change from baseline with treatment, baseline MAS score, BTX treatment status at baseline and centre as covariates.', 'groupDescription': 'The least squares mean change from baseline to Week 4 for barefoot comfortable walking speed in the Dysport® 1500 U and Placebo groups were compared using 2 contrast analyses within a single mixed effect ANCOVA model, controlling for the baseline values, the randomisation stratification factor (BTX treatment status at baseline) and the centre, all as fixed effects.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Comfortable walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made barefoot, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Week 4 is reported.', 'unitOfMeasure': 'm/s', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data at baseline and Week 4 are included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Least Squares Mean Change From Baseline in MAS Score in the GSC (Knee Extended) at Weeks 1 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '-0.3'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '-0.4'}, {'value': '-0.4', 'groupId': 'OG002', 'lowerLimit': '-0.5', 'upperLimit': '-0.2'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '-0.2'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '-0.4'}, {'value': '-0.4', 'groupId': 'OG002', 'lowerLimit': '-0.5', 'upperLimit': '-0.2'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1 and 12', 'description': 'Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 1, 4 and 12, at discretionary visits at Weeks 16, 20 and 24, and at end of study. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. The least squares mean change from baseline at Weeks 1 and 12 are reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Least Squares Mean Change From Baseline in MAS Score in the Soleus (Knee Flexed) at Weeks 1, 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '-0.2'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '-0.4'}, {'value': '-0.4', 'groupId': 'OG002', 'lowerLimit': '-0.6', 'upperLimit': '-0.3'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '-0.5'}, {'value': '-0.8', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '-0.7'}, {'value': '-0.4', 'groupId': 'OG002', 'lowerLimit': '-0.6', 'upperLimit': '-0.3'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '-0.4'}, {'value': '-0.6', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '-0.4'}, {'value': '-0.3', 'groupId': 'OG002', 'lowerLimit': '-0.4', 'upperLimit': '-0.1'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Muscle tone in the treated limb was assessed by MAS in the soleus (with the knee flexed) at baseline, at Weeks 1, 4 and 12, at discretionary visits at Weeks 16, 20 and 24, and at end of study. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'PGA of Treatment Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '0.7'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '0.8'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '0.7'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At Week 12', 'description': "An assessment of overall treatment response was conducted at Weeks 4 and 12, and discretionary visits at Weeks 16, 20 and 24 and at end of study by an investigator who had not assessed the MAS. The investigator rated the response to treatment in the subject's lower limb after injection of Dysport® relative to the status at the baseline. Answers were made on a 9 point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. The mean PGA scores at Week 12 are reported.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data at Week 12 are included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Least Squares Mean Change From Baseline in Comfortable Barefoot Walking Speed at Weeks 1 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.07'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.05'}, {'value': '0.04', 'groupId': 'OG002', 'lowerLimit': '0.02', 'upperLimit': '0.05'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.09'}, {'value': '0.06', 'groupId': 'OG001', 'lowerLimit': '0.04', 'upperLimit': '0.08'}, {'value': '0.05', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.07'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1 and 12', 'description': 'Comfortable walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made barefoot, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1 and 12 are reported.', 'unitOfMeasure': 'm/s', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Least Squares Mean Change From Baseline in Comfortable Walking Speed With Shoes at Weeks 1, 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '0.07'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.07'}, {'value': '0.04', 'groupId': 'OG002', 'lowerLimit': '0.02', 'upperLimit': '0.05'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '0.07'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.06'}, {'value': '0.06', 'groupId': 'OG002', 'lowerLimit': '0.04', 'upperLimit': '0.08'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.08'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.07'}, {'value': '0.05', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.07'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Comfortable walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made with shoes, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.', 'unitOfMeasure': 'm/s', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Least Squares Mean Change From Baseline in Maximal Barefoot Walking Speed at Weeks 1, 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.08'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.07'}, {'value': '0.05', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.07'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.10'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.06'}, {'value': '0.05', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.08'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '0.12'}, {'value': '0.06', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.08'}, {'value': '0.06', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.09'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Maximal walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made barefoot, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and are reported.', 'unitOfMeasure': 'm/s', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Least Squares Mean Change From Baseline in Maximal Walking Speed With Shoes at Weeks 1, 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '0.07'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.07'}, {'value': '0.04', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.06'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '0.08'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.07'}, {'value': '0.05', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.08'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.10'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.08'}, {'value': '0.05', 'groupId': 'OG002', 'lowerLimit': '0.02', 'upperLimit': '0.08'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Maximal walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made with shoes, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.', 'unitOfMeasure': 'm/s', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Least Squares Mean Change From Baseline in Cadence With Comfortable Walking Speed With Shoes at Weeks 1, 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.10'}, {'value': '0.07', 'groupId': 'OG001', 'lowerLimit': '0.04', 'upperLimit': '0.10'}, {'value': '0.04', 'groupId': 'OG002', 'lowerLimit': '0.01', 'upperLimit': '0.07'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.10'}, {'value': '0.06', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.10'}, {'value': '0.06', 'groupId': 'OG002', 'lowerLimit': '0.02', 'upperLimit': '0.09'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.12'}, {'value': '0.06', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.09'}, {'value': '0.05', 'groupId': 'OG002', 'lowerLimit': '0.01', 'upperLimit': '0.08'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Cadence was assessed during the 10-metre walking speed test at comfortable walking speed and with shoes. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.', 'unitOfMeasure': 'steps/s', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Least Squares Mean Change From Baseline in Average Step Length With Comfortable Walking Speed With Shoes at Weeks 1, 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.03'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.03'}, {'value': '0.02', 'groupId': 'OG002', 'lowerLimit': '0.01', 'upperLimit': '0.03'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.03'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.02'}, {'value': '0.03', 'groupId': 'OG002', 'lowerLimit': '0.02', 'upperLimit': '0.04'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.03'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.04'}, {'value': '0.03', 'groupId': 'OG002', 'lowerLimit': '0.01', 'upperLimit': '0.04'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Average step length was assessed during the 10-metre walking speed test at comfortable walking speed and with shoes. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.', 'unitOfMeasure': 'm/step', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Least Squares Mean Change From Baseline in Cadence With Comfortable Barefoot Walking Speed at Weeks 1, 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '0.07', 'upperLimit': '0.13'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.08'}, {'value': '0.05', 'groupId': 'OG002', 'lowerLimit': '0.02', 'upperLimit': '0.08'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.11'}, {'value': '0.06', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.10'}, {'value': '0.06', 'groupId': 'OG002', 'lowerLimit': '0.02', 'upperLimit': '0.09'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.12', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '0.15'}, {'value': '0.08', 'groupId': 'OG001', 'lowerLimit': '0.05', 'upperLimit': '0.12'}, {'value': '0.07', 'groupId': 'OG002', 'lowerLimit': '0.04', 'upperLimit': '0.11'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Cadence was assessed during the 10-metre walking speed test at comfortable walking speed and barefoot. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported', 'unitOfMeasure': 'steps/s', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Least Squares Mean Change From Baseline in Average Step Length With Comfortable Barefoot Walking Speed at Weeks 1, 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.02'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.02'}, {'value': '0.01', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.02'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.03'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.03'}, {'value': '0.02', 'groupId': 'OG002', 'lowerLimit': '0.01', 'upperLimit': '0.03'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.03'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.03'}, {'value': '0.02', 'groupId': 'OG002', 'lowerLimit': '0.01', 'upperLimit': '0.03'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Average step length was assessed during the 10-metre walking speed test at comfortable walking speed and barefoot. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.', 'unitOfMeasure': 'm/step', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Least Squares Mean Change From Baseline in Cadence With Maximal Walking Speed With Shoes at Weeks 1, 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.09'}, {'value': '0.07', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.10'}, {'value': '0.04', 'groupId': 'OG002', 'lowerLimit': '0.01', 'upperLimit': '0.08'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.09'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.09'}, {'value': '0.05', 'groupId': 'OG002', 'lowerLimit': '0.02', 'upperLimit': '0.09'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.12'}, {'value': '0.07', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.11'}, {'value': '0.04', 'groupId': 'OG002', 'lowerLimit': '-0.00', 'upperLimit': '0.08'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Cadence was assessed during the 10-metre walking speed test at maximal walking speed and with shoes. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.', 'unitOfMeasure': 'steps/s', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Least Squares Mean Change From Baseline in Average Step Length With Maximal Walking Speed With Shoes at Weeks 1, 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.03'}, {'value': '0.01', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.03'}, {'value': '0.02', 'groupId': 'OG002', 'lowerLimit': '0.01', 'upperLimit': '0.04'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.03'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.03'}, {'value': '0.02', 'groupId': 'OG002', 'lowerLimit': '0.01', 'upperLimit': '0.03'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.03'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.03'}, {'value': '0.03', 'groupId': 'OG002', 'lowerLimit': '0.01', 'upperLimit': '0.04'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Average step length was assessed during the 10-metre walking speed test at maximal walking speed and with shoes. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.', 'unitOfMeasure': 'm/step', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Least Squares Mean Change From Baseline in Cadence With Maximal Barefoot Walking Speed at Weeks 1, 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.07', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.11'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.09'}, {'value': '0.06', 'groupId': 'OG002', 'lowerLimit': '0.02', 'upperLimit': '0.09'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.12'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.09'}, {'value': '0.07', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '0.10'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.12', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '0.16'}, {'value': '0.08', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.12'}, {'value': '0.06', 'groupId': 'OG002', 'lowerLimit': '0.02', 'upperLimit': '0.11'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Cadence was assessed during the 10-metre walking speed test at maximal walking speed and barefoot. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.', 'unitOfMeasure': 'steps/s', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Least Squares Mean Change From Baseline in Average Step Length With Maximal Barefoot Walking Speed at Weeks 1, 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.03'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.03'}, {'value': '0.02', 'groupId': 'OG002', 'lowerLimit': '0.01', 'upperLimit': '0.03'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.04'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.03'}, {'value': '0.02', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.03'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.02', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.03'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.03'}, {'value': '0.02', 'groupId': 'OG002', 'lowerLimit': '0.01', 'upperLimit': '0.04'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Average step length was assessed during the 10-metre walking speed test at maximal walking speed and barefoot. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.', 'unitOfMeasure': 'm/step', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Least Squares Mean Change From Baseline in the Tardieu Scale in the GSC (Knee Extended) at Weeks 1, 4 and 12: Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}], 'classes': [{'title': 'Week 1: Angle of Arrest (XV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '3.4'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '3.3'}, {'value': '1.7', 'groupId': 'OG002', 'lowerLimit': '0.7', 'upperLimit': '2.6'}]}]}, {'title': 'Week 4: Angle of Arrest (XV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '1.9'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '2.6'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '2.5'}]}]}, {'title': 'Week 12: Angle of Arrest (XV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '-0.9', 'upperLimit': '1.7'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '-0.9', 'upperLimit': '1.6'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '-0.8', 'upperLimit': '1.7'}]}]}, {'title': 'Week 1: Angle of Catch (XV3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '6.5'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '6.7'}, {'value': '3.2', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '4.5'}]}]}, {'title': 'Week 4: Angle of Catch (XV3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '6.3'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '6.8'}, {'value': '3.4', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '4.9'}]}]}, {'title': 'Week 12: Angle of Catch (XV3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '4.6'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '4.5'}, {'value': '2.6', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '4.2'}]}]}, {'title': 'Week 1: Spasticity Angle (X)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG000', 'lowerLimit': '-3.7', 'upperLimit': '-1.3'}, {'value': '-3.2', 'groupId': 'OG001', 'lowerLimit': '-4.4', 'upperLimit': '-2.0'}, {'value': '-1.7', 'groupId': 'OG002', 'lowerLimit': '-2.8', 'upperLimit': '-0.5'}]}]}, {'title': 'Week 4: Spasticity Angle (X)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.0', 'groupId': 'OG000', 'lowerLimit': '-5.2', 'upperLimit': '-2.8'}, {'value': '-4.0', 'groupId': 'OG001', 'lowerLimit': '-5.2', 'upperLimit': '-2.8'}, {'value': '-2.5', 'groupId': 'OG002', 'lowerLimit': '-3.7', 'upperLimit': '-1.3'}]}]}, {'title': 'Week 12: Spasticity Angle (X)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'groupId': 'OG000', 'lowerLimit': '-3.7', 'upperLimit': '-1.1'}, {'value': '-2.8', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '-1.5'}, {'value': '-2.3', 'groupId': 'OG002', 'lowerLimit': '-3.5', 'upperLimit': '-1.0'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'The Tardieu Scale in the GSC was used to assess spasticity with the knee extended. Assessments were made at slow (V1) and fast (V3) speeds of stretch. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest (XV1), either due to subject discomfort or a mechanical resistance. The same movement is repeated at a fast speed to determine the angle of catch and release (XV3). The spasticity angle (X) was calculated as the difference between XV1 and XV3. The Tardieu Scale ratings were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits if required at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.', 'unitOfMeasure': 'Degrees', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Least Squares Mean Change From Baseline in the Tardieu Scale in the GSC (Knee Extended) at Weeks 1, 4 and 12: Spasticity Grade (Y)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '-0.1'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-0.4', 'upperLimit': '-0.2'}, {'value': '-0.2', 'groupId': 'OG002', 'lowerLimit': '-0.3', 'upperLimit': '-0.1'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '-0.2'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '-0.3'}, {'value': '-0.1', 'groupId': 'OG002', 'lowerLimit': '-0.2', 'upperLimit': '-0.0'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '-0.2'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '-0.3'}, {'value': '-0.1', 'groupId': 'OG002', 'lowerLimit': '-0.2', 'upperLimit': '-0.0'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'The Tardieu Scale in the GSC was used to assess spasticity with the knee extended. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 = no resistance throughout passive movement; 1 = slight resistance throughout passive movement; 2 = clear catch at precise angle, interrupting passive movement, followed by release; 3 = fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release; 4 = unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. The Tardieu Scale ratings were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits if required at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline for spasticity grade at Weeks 1, 4 and 12 are reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Least Squares Mean Change From Baseline in the Tardieu Scale in the Soleus (Knee Flexed) at Weeks 1, 4 and 12: Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}], 'classes': [{'title': 'Week 1: Angle of Arrest (XV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '3.2'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '2.5'}, {'value': '1.4', 'groupId': 'OG002', 'lowerLimit': '0.4', 'upperLimit': '2.3'}]}]}, {'title': 'Week 4: Angle of Arrest (XV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '2.3'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '2.1'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '2.4'}]}]}, {'title': 'Week 12: Angle of Arrest (XV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '1.5'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '1.1'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '-1.0', 'upperLimit': '1.1'}]}]}, {'title': 'Week 1: Angle of Catch (XV3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '5.8'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '5.8'}, {'value': '2.5', 'groupId': 'OG002', 'lowerLimit': '0.9', 'upperLimit': '4.1'}]}]}, {'title': 'Week 4: Angle of Catch (XV3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '6.6'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '6.4'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '1.5', 'upperLimit': '4.4'}]}]}, {'title': 'Week 12: Angle of Catch (XV3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '5.4'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '5.1'}, {'value': '2.7', 'groupId': 'OG002', 'lowerLimit': '1.2', 'upperLimit': '4.1'}]}]}, {'title': 'Week 1: Spasticity Angle (X)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'groupId': 'OG000', 'lowerLimit': '-3.1', 'upperLimit': '-0.2'}, {'value': '-2.8', 'groupId': 'OG001', 'lowerLimit': '-4.2', 'upperLimit': '-1.4'}, {'value': '-1.3', 'groupId': 'OG002', 'lowerLimit': '-2.6', 'upperLimit': '-0.1'}]}]}, {'title': 'Week 4: Spasticity Angle (X)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'groupId': 'OG000', 'lowerLimit': '-4.9', 'upperLimit': '-2.4'}, {'value': '-4.2', 'groupId': 'OG001', 'lowerLimit': '-5.5', 'upperLimit': '-3.0'}, {'value': '-1.8', 'groupId': 'OG002', 'lowerLimit': '-3.1', 'upperLimit': '-0.6'}]}]}, {'title': 'Week 12: Spasticity Angle (X)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'groupId': 'OG000', 'lowerLimit': '-4.6', 'upperLimit': '-2.1'}, {'value': '-3.9', 'groupId': 'OG001', 'lowerLimit': '-5.2', 'upperLimit': '-2.7'}, {'value': '-2.8', 'groupId': 'OG002', 'lowerLimit': '-4.1', 'upperLimit': '-1.6'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'The Tardieu Scale in the soleus was used to assess spasticity with the knee flexed. Assessments were made at slow (V1) and fast (V3) speeds of stretch. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest (XV1), either due to subject discomfort or a mechanical resistance. The same movement is repeated at a fast speed to determine the angle of catch and release (XV3). The spasticity angle (X) was calculated as the difference between XV1 and XV3. The Tardieu Scale ratings were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits if required at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.', 'unitOfMeasure': 'Degrees', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Least Squares Mean Change From Baseline in the Tardieu Scale in the Soleus (Knee Flexed) at Weeks 1, 4 and 12: Spasticity Grade (Y)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '-0.1'}, {'value': '-0.3', 'groupId': 'OG001', 'lowerLimit': '-0.4', 'upperLimit': '-0.2'}, {'value': '-0.1', 'groupId': 'OG002', 'lowerLimit': '-0.2', 'upperLimit': '-0.0'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '-0.3'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '-0.4'}, {'value': '-0.1', 'groupId': 'OG002', 'lowerLimit': '-0.2', 'upperLimit': '-0.0'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '-0.3'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '-0.3'}, {'value': '-0.1', 'groupId': 'OG002', 'lowerLimit': '-0.2', 'upperLimit': '-0.0'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'The Tardieu Scale in the soleus was used to assess spasticity with the knee flexed. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 = no resistance throughout passive movement; 1 = slight resistance throughout passive movement; 2 = clear catch at precise angle, interrupting passive movement, followed by release; 3 = fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release; 4 = unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. The Tardieu Scale ratings were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits if required at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline for spasticity grade at Weeks 1, 4 and 12 are reported.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Least Squares Mean Change From Baseline in the Range of Active Dorsiflexion at Weeks 1, 4 and 12 (Knee Extended and Flexed)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}], 'classes': [{'title': 'Week 1: Knee Extended', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '3.0'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '3.7'}, {'value': '1.1', 'groupId': 'OG002', 'lowerLimit': '-0.2', 'upperLimit': '2.4'}]}]}, {'title': 'Week 4: Knee Extended', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '3.1'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '5.3'}, {'value': '1.6', 'groupId': 'OG002', 'lowerLimit': '-0.1', 'upperLimit': '3.2'}]}]}, {'title': 'Week 12: Knee Extended', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '2.7'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '3.6'}, {'value': '1.7', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '3.2'}]}]}, {'title': 'Week 1: Knee Flexed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '4.4'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '3.4'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '3.3'}]}]}, {'title': 'Week 4: Knee Flexed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '4.5'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '4.9'}, {'value': '2.7', 'groupId': 'OG002', 'lowerLimit': '1.2', 'upperLimit': '4.2'}]}]}, {'title': 'Week 12: Knee Flexed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '3.6'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '2.9'}, {'value': '1.8', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '3.3'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Range of active dorsiflexion of the ankle joint, both with the knee flexed (90°) and extended (measured by goniometry) was used to assess treatment response. The measurements were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits when needed at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.', 'unitOfMeasure': 'Degrees', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Least Squares Mean Change From Baseline in Lower Limb Pain at Weeks 1, 4 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received i.m. injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '-0.1'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '0.0'}, {'value': '-0.2', 'groupId': 'OG002', 'lowerLimit': '-0.3', 'upperLimit': '-0.0'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '128', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'OG000', 'lowerLimit': '-0.3', 'upperLimit': '-0.1'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-0.4', 'upperLimit': '0.0'}, {'value': '-0.1', 'groupId': 'OG002', 'lowerLimit': '-0.3', 'upperLimit': '0.1'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '0.0'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-0.3', 'upperLimit': '0.1'}, {'value': '0.1', 'groupId': 'OG002', 'lowerLimit': '-0.1', 'upperLimit': '0.3'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': "The intensity of lower limb pain was evaluated using the Scale of Pain Intensity (SPIN) which provided a pictorial representation of pain in a 6-point graphic scale with the degree of red shading inside a circle representing the intensity of pain. The bottom and top of the scale are anchored by two extremes: 'no pain' (circle with no red shading and scored as 0) and 'pain as bad as it could be' (circle completely red and scored as 5), marked with either verbal or visual cues. The intervening points are represented by red circles increasing proportionally in size. The subject marks the circle that best indicates their pain intensity. The SPIN assessments were obtained prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits when needed at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.", 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a MAS score in the GSC assessed at baseline (pre-treatment) and at Week 4. Only subjects with data available at each timepoint presented are included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received intramuscular (i.m.) injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'FG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}, {'groupId': 'FG001', 'numSubjects': '129'}, {'groupId': 'FG002', 'numSubjects': '132'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '121'}, {'groupId': 'FG002', 'numSubjects': '125'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Study treatment not received', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'No MAS Score at baseline and/or Week 4', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Botulinum toxin (BTX) in upper limb', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Non compliance to visit schedule', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was designed as a mutlicentre study and included 62 investigational centres in Australia, Belgium, the Czech Republic, France, Hungary, Italy, Poland, Portugal, Russia, Slovakia and the United States. Subjects were screened at 53 centres and in 52 centres subjects were randomised to receive study treatment.', 'preAssignmentDetails': 'A total of 456 subjects were screened, 388 were enrolled into the study and randomised to 1 of 3 treatment groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}, {'value': '381', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Dysport® 1000 U', 'description': 'Subjects received i.m.injections of Dysport® 1000 Units (U) (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'BG001', 'title': 'Dysport® 1500 U', 'description': 'Subjects received i.m. injections of Dysport® 1500 U (maximum total dose) into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Subjects received i.m. injections of placebo into the soleus muscle and gastrocnemius (medial and/or lateral) muscle and at least one of the distal or proximal muscles of the leg on Day 1 of the single treatment cycle.'}, {'id': 'BG003', 'title': 'Total Title'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.2', 'spread': '13.2', 'groupId': 'BG000'}, {'value': '53.3', 'spread': '12.0', 'groupId': 'BG001'}, {'value': '51.4', 'spread': '12.9', 'groupId': 'BG002'}, {'value': '52.6', 'spread': '12.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '256', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Caucasian or White', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '344', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Multiple', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The ITT population included all randomised subjects who received at least 1 injection of study medication and who had a Modified Ashworth Scale (MAS) score in the gastrocnemius-soleus (GSC) assessed at baseline (pre-treatment) and at Week 4.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 388}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'dispFirstSubmitDate': '2015-05-07', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-15', 'studyFirstSubmitDate': '2010-11-25', 'dispFirstSubmitQcDate': '2015-05-07', 'resultsFirstSubmitDate': '2017-07-03', 'studyFirstSubmitQcDate': '2010-11-25', 'dispFirstPostDateStruct': {'date': '2015-05-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-09-14', 'studyFirstPostDateStruct': {'date': '2010-11-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Least Squares Mean Change From Baseline in MAS Score in the GSC (Knee Extended) at Weeks 1 and 12', 'timeFrame': 'Baseline and Weeks 1 and 12', 'description': 'Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 1, 4 and 12, at discretionary visits at Weeks 16, 20 and 24, and at end of study. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. The least squares mean change from baseline at Weeks 1 and 12 are reported.'}, {'measure': 'Least Squares Mean Change From Baseline in MAS Score in the Soleus (Knee Flexed) at Weeks 1, 4 and 12', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Muscle tone in the treated limb was assessed by MAS in the soleus (with the knee flexed) at baseline, at Weeks 1, 4 and 12, at discretionary visits at Weeks 16, 20 and 24, and at end of study. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.'}, {'measure': 'PGA of Treatment Response at Week 12', 'timeFrame': 'At Week 12', 'description': "An assessment of overall treatment response was conducted at Weeks 4 and 12, and discretionary visits at Weeks 16, 20 and 24 and at end of study by an investigator who had not assessed the MAS. The investigator rated the response to treatment in the subject's lower limb after injection of Dysport® relative to the status at the baseline. Answers were made on a 9 point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. The mean PGA scores at Week 12 are reported."}, {'measure': 'Least Squares Mean Change From Baseline in Comfortable Barefoot Walking Speed at Weeks 1 and 12', 'timeFrame': 'Baseline and Weeks 1 and 12', 'description': 'Comfortable walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made barefoot, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1 and 12 are reported.'}, {'measure': 'Least Squares Mean Change From Baseline in Comfortable Walking Speed With Shoes at Weeks 1, 4 and 12', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Comfortable walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made with shoes, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.'}, {'measure': 'Least Squares Mean Change From Baseline in Maximal Barefoot Walking Speed at Weeks 1, 4 and 12', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Maximal walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made barefoot, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and are reported.'}, {'measure': 'Least Squares Mean Change From Baseline in Maximal Walking Speed With Shoes at Weeks 1, 4 and 12', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Maximal walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made with shoes, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.'}, {'measure': 'Least Squares Mean Change From Baseline in Cadence With Comfortable Walking Speed With Shoes at Weeks 1, 4 and 12', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Cadence was assessed during the 10-metre walking speed test at comfortable walking speed and with shoes. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.'}, {'measure': 'Least Squares Mean Change From Baseline in Average Step Length With Comfortable Walking Speed With Shoes at Weeks 1, 4 and 12', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Average step length was assessed during the 10-metre walking speed test at comfortable walking speed and with shoes. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.'}, {'measure': 'Least Squares Mean Change From Baseline in Cadence With Comfortable Barefoot Walking Speed at Weeks 1, 4 and 12', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Cadence was assessed during the 10-metre walking speed test at comfortable walking speed and barefoot. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported'}, {'measure': 'Least Squares Mean Change From Baseline in Average Step Length With Comfortable Barefoot Walking Speed at Weeks 1, 4 and 12', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Average step length was assessed during the 10-metre walking speed test at comfortable walking speed and barefoot. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.'}, {'measure': 'Least Squares Mean Change From Baseline in Cadence With Maximal Walking Speed With Shoes at Weeks 1, 4 and 12', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Cadence was assessed during the 10-metre walking speed test at maximal walking speed and with shoes. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.'}, {'measure': 'Least Squares Mean Change From Baseline in Average Step Length With Maximal Walking Speed With Shoes at Weeks 1, 4 and 12', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Average step length was assessed during the 10-metre walking speed test at maximal walking speed and with shoes. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.'}, {'measure': 'Least Squares Mean Change From Baseline in Cadence With Maximal Barefoot Walking Speed at Weeks 1, 4 and 12', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Cadence was assessed during the 10-metre walking speed test at maximal walking speed and barefoot. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.'}, {'measure': 'Least Squares Mean Change From Baseline in Average Step Length With Maximal Barefoot Walking Speed at Weeks 1, 4 and 12', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Average step length was assessed during the 10-metre walking speed test at maximal walking speed and barefoot. The evaluator walked beside the subject during the test and counted the number of steps taken during the 10-metre walk. The gait parameters were measured at baseline, Weeks 1, 4 and 12, discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.'}, {'measure': 'Least Squares Mean Change From Baseline in the Tardieu Scale in the GSC (Knee Extended) at Weeks 1, 4 and 12: Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X)', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'The Tardieu Scale in the GSC was used to assess spasticity with the knee extended. Assessments were made at slow (V1) and fast (V3) speeds of stretch. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest (XV1), either due to subject discomfort or a mechanical resistance. The same movement is repeated at a fast speed to determine the angle of catch and release (XV3). The spasticity angle (X) was calculated as the difference between XV1 and XV3. The Tardieu Scale ratings were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits if required at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.'}, {'measure': 'Least Squares Mean Change From Baseline in the Tardieu Scale in the GSC (Knee Extended) at Weeks 1, 4 and 12: Spasticity Grade (Y)', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'The Tardieu Scale in the GSC was used to assess spasticity with the knee extended. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 = no resistance throughout passive movement; 1 = slight resistance throughout passive movement; 2 = clear catch at precise angle, interrupting passive movement, followed by release; 3 = fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release; 4 = unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. The Tardieu Scale ratings were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits if required at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline for spasticity grade at Weeks 1, 4 and 12 are reported.'}, {'measure': 'Least Squares Mean Change From Baseline in the Tardieu Scale in the Soleus (Knee Flexed) at Weeks 1, 4 and 12: Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X)', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'The Tardieu Scale in the soleus was used to assess spasticity with the knee flexed. Assessments were made at slow (V1) and fast (V3) speeds of stretch. Slow speed of muscle stretch measures the range of passive motion. During a slow stretching movement, the examiner determines the angle of movement arrest (XV1), either due to subject discomfort or a mechanical resistance. The same movement is repeated at a fast speed to determine the angle of catch and release (XV3). The spasticity angle (X) was calculated as the difference between XV1 and XV3. The Tardieu Scale ratings were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits if required at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.'}, {'measure': 'Least Squares Mean Change From Baseline in the Tardieu Scale in the Soleus (Knee Flexed) at Weeks 1, 4 and 12: Spasticity Grade (Y)', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'The Tardieu Scale in the soleus was used to assess spasticity with the knee flexed. The spasticity grade (Y) assesses quality of muscle reaction on a 5-point scale (measured at fast speed): 0 = no resistance throughout passive movement; 1 = slight resistance throughout passive movement; 2 = clear catch at precise angle, interrupting passive movement, followed by release; 3 = fatigable clonus (less than 10 seconds when maintaining pressure) occurring at a precise angle, followed by release; 4 = unfatigable clonus (more than 10 seconds when maintaining pressure) occurring at precise angle. The Tardieu Scale ratings were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits if required at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline for spasticity grade at Weeks 1, 4 and 12 are reported.'}, {'measure': 'Least Squares Mean Change From Baseline in the Range of Active Dorsiflexion at Weeks 1, 4 and 12 (Knee Extended and Flexed)', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': 'Range of active dorsiflexion of the ankle joint, both with the knee flexed (90°) and extended (measured by goniometry) was used to assess treatment response. The measurements were made prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits when needed at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported.'}, {'measure': 'Least Squares Mean Change From Baseline in Lower Limb Pain at Weeks 1, 4 and 12', 'timeFrame': 'Baseline and Weeks 1, 4 and 12', 'description': "The intensity of lower limb pain was evaluated using the Scale of Pain Intensity (SPIN) which provided a pictorial representation of pain in a 6-point graphic scale with the degree of red shading inside a circle representing the intensity of pain. The bottom and top of the scale are anchored by two extremes: 'no pain' (circle with no red shading and scored as 0) and 'pain as bad as it could be' (circle completely red and scored as 5), marked with either verbal or visual cues. The intervening points are represented by red circles increasing proportionally in size. The subject marks the circle that best indicates their pain intensity. The SPIN assessments were obtained prior to the study treatment at baseline, and then after injection at Weeks 1, 4 and 12, and at discretionary visits when needed at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Weeks 1, 4 and 12 are reported."}], 'primaryOutcomes': [{'measure': 'Least Squares Mean Change From Baseline to Week 4 in the MAS Score in the Gastrocnemius-soleus Complex (GSC) (Knee Extended)', 'timeFrame': 'Baseline and Week 4', 'description': 'Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 1, 4 and 12, at discretionary visits at Weeks 16, 20 and 24, and at end of study. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM)), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. The least squares mean change from baseline at Week 4 is reported.'}], 'secondaryOutcomes': [{'measure': "Physician's Global Assesment (PGA) of Treatment Response at Week 4", 'timeFrame': 'At Week 4', 'description': "An assessment of overall treatment response was conducted at Weeks 4 and 12, and discretionary visits at Weeks 16, 20 and 24 and at end of study by an investigator who had not assessed the MAS. The investigator rated the response to treatment in the subject's lower limb after injection of Dysport® relative to the status at the baseline. Answers were made on a 9 point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. The mean PGA score at Week 4 is reported."}, {'measure': 'Least Squares Mean Change From Baseline to Week 4 in Comfortable Barefoot Walking Speed', 'timeFrame': 'Baseline and Week 4', 'description': 'Comfortable walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made barefoot, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Week 4 is reported.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Leg Spasticity']}, 'referencesModule': {'references': [{'pmid': '32741133', 'type': 'DERIVED', 'citation': "Esquenazi A, Brashear A, Deltombe T, Rudzinska-Bar M, Krawczyk M, Skoromets A, O'Dell MW, Grandoulier AS, Vilain C, Picaut P, Gracies JM. The Effect of Repeated abobotulinumtoxinA (Dysport(R)) Injections on Walking Velocity in Persons with Spastic Hemiparesis Caused by Stroke or Traumatic Brain Injury. PM R. 2021 May;13(5):488-495. doi: 10.1002/pmrj.12459. Epub 2020 Sep 11."}, {'pmid': '32108436', 'type': 'DERIVED', 'citation': 'Esquenazi A, Stoquart G, Hedera P, Jacinto LJ, Dimanico U, Constant-Boyer F, Brashear A, Grandoulier AS, Vilain C, Picaut P, Gracies JM. Efficacy and Safety of AbobotulinumtoxinA for the Treatment of Hemiparesis in Adults with Lower Limb Spasticity Previously Treated With Other Botulinum Toxins: A Secondary Analysis of a Randomized Controlled Trial. PM R. 2020 Sep;12(9):853-860. doi: 10.1002/pmrj.12348. Epub 2020 Mar 27.'}, {'pmid': '29093068', 'type': 'DERIVED', 'citation': 'Gracies JM, Esquenazi A, Brashear A, Banach M, Kocer S, Jech R, Khatkova S, Benetin J, Vecchio M, McAllister P, Ilkowski J, Ochudlo S, Catus F, Grandoulier AS, Vilain C, Picaut P; International AbobotulinumtoxinA Adult Lower Limb Spasticity Study Group. Efficacy and safety of abobotulinumtoxinA in spastic lower limb: Randomized trial and extension. Neurology. 2017 Nov 28;89(22):2245-2253. doi: 10.1212/WNL.0000000000004687. Epub 2017 Nov 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to assess the efficacy of Dysport® compared to placebo in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects aged 18 to 80 years of age\n* Post stroke or brain injury\n* Intensity of muscle tone greater than or equal to 2, as measured on the Modified Ashworth Scale\n* Ambulatory patients\n\nExclusion Criteria:\n\n* Fixed contractures\n* Physiotherapy initiated less than 4 weeks before entry\n* Previous surgery or previous treatment with phenol and/or alcohol in lower limb\n* Neurological/neuromuscular disorders which may interfere with protocol evaluations'}, 'identificationModule': {'nctId': 'NCT01249404', 'briefTitle': 'Dysport® Adult Lower Limb Spasticity Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'A Phase III, Multicentre, Double-blind, Prospective, Randomized, Placebo-controlled Study, Assessing the Efficacy and Safety of Dysport® Used for the Treatment of Lower-limb Spasticity in Adult Subjects With Hemiparesis Due to Stroke or Traumatic Brain Injury', 'orgStudyIdInfo': {'id': 'Y-55-52120-140'}, 'secondaryIdInfos': [{'id': '2009-015868-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dysport® 1000 U, IM', 'description': '1000 U, I.M. 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