Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:37 AM
Study NCT ID:
NCT00257660
Status:
COMPLETED
Last Update Posted:
2022-09-28
First Post:
2005-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014103', 'term': 'Torticollis'}], 'ancestors': [{'id': 'D004421', 'term': 'Dystonia'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'Senior Director, Medical Development, Neurology', 'organization': 'Ipsen'}, 'certainAgreement': {'otherDetails': 'A publication of results from all sites in this multicenter study is expected. If the sponsor no longer plans this or 6 months after study completion at all sites, the PI may publish the results. He will supply any proposed publication to the sponsor for review and comment at least 30 days before submission for publication. If the sponsor believes a patent application should be filed, the publication will be delayed for another 60 days or until patent filing; with a maximum delay of 90 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Dysport 500 Units', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible', 'otherNumAtRisk': 55, 'otherNumAffected': 11, 'seriousNumAtRisk': 55, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible', 'otherNumAtRisk': 61, 'otherNumAffected': 5, 'seriousNumAtRisk': 61, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}], 'seriousEvents': [{'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport 500 Units', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}], 'classes': [{'title': 'Change in TWSTRS total score', 'categories': [{'measurements': [{'value': '-13.99', 'spread': '12.33', 'groupId': 'OG000'}, {'value': '-5.23', 'spread': '9.33', 'groupId': 'OG001'}]}]}, {'title': 'Baseline TWSTRS total score', 'categories': [{'measurements': [{'value': '43.83', 'spread': '7.97', 'groupId': 'OG000'}, {'value': '45.81', 'spread': '8.78', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 TWSTRS total score', 'categories': [{'measurements': [{'value': '30.04', 'spread': '12.65', 'groupId': 'OG000'}, {'value': '40.22', 'spread': '11.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.84', 'ciLowerLimit': '-12.94', 'ciUpperLimit': '-4.74', 'pValueComment': 'A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\\<0.05 was considered significant.', 'estimateComment': 'Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the analysis at Week 4 excludes the scores for the 7 subjects who were not assessed.\n\nMean difference = difference in adjusted least squares mean (Dysport - Placebo).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Treatment group, baseline TWSTRS score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'TWSTRS is comprised of three different components which are severity, disability \\& pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 4 subjects for Dysport and 3 for placebo who were not assessed on TWSTRS score at Week 4. As there was no imputation of missing TWSTRS score values, these 7 subjects were not taken into account.'}, {'type': 'SECONDARY', 'title': 'Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport 500 Units', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}], 'classes': [{'title': 'Change in TWSTRS total score', 'categories': [{'measurements': [{'value': '-13.82', 'spread': '11.53', 'groupId': 'OG000'}, {'value': '-5.59', 'spread': '11.37', 'groupId': 'OG001'}]}]}, {'title': 'Baseline TWSTRS total score', 'categories': [{'measurements': [{'value': '43.83', 'spread': '7.97', 'groupId': 'OG000'}, {'value': '45.81', 'spread': '8.78', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 TWSTRS total score', 'categories': [{'measurements': [{'value': '29.31', 'spread': '10.99', 'groupId': 'OG000'}, {'value': '39.64', 'spread': '13.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-8.81', 'ciLowerLimit': '-12.91', 'ciUpperLimit': '-4.71', 'pValueComment': 'A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\\<0.05 was considered significant.', 'estimateComment': 'Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the Week 8 analysis excludes the scores for the 24 subjects who were not assessed.\n\nMean difference = difference in adjusted least squares mean (Dysport - Placebo).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Treatment group, baseline TWSTRS score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8', 'description': 'TWSTRS is comprised of three different components which are severity, disability \\& pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 9 subjects for Dysport and 15 for placebo who were not assessed on TWSTRS score at Week 8. As there was no imputation of missing TWSTRS score values, these 24 subjects were not taken into account.'}, {'type': 'SECONDARY', 'title': 'Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport 500 Units', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}], 'classes': [{'title': 'Change in TWSTRS total score', 'categories': [{'measurements': [{'value': '-6.98', 'spread': '11.12', 'groupId': 'OG000'}, {'value': '-4.53', 'spread': '7.75', 'groupId': 'OG001'}]}]}, {'title': 'Baseline TWSTRS total score', 'categories': [{'measurements': [{'value': '43.83', 'spread': '7.97', 'groupId': 'OG000'}, {'value': '45.81', 'spread': '8.78', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 TWSTRS total score', 'categories': [{'measurements': [{'value': '36.04', 'spread': '11.76', 'groupId': 'OG000'}, {'value': '40.76', 'spread': '11.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-4.12', 'ciLowerLimit': '-7.55', 'ciUpperLimit': '-0.68', 'pValueComment': 'A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\\<0.05 was considered significant.', 'estimateComment': 'Baseline TWSTRS total scores are analysed for all subjects of ITT population, while the Week 12 analysis excludes the scores for the 27 subjects who were not assessed.\n\nMean difference = difference in adjusted least squares mean (Dysport - Placebo).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Treatment group, baseline TWSTRS score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'TWSTRS is comprised of three different components which are severity, disability \\& pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 10 subjects for Dysport and 17 for placebo who were not assessed on TWSTRS score at Week 12. As there was no imputation of missing TWSTRS score values, these 27 subjects were not taken into account.'}, {'type': 'SECONDARY', 'title': 'Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport 500 Units', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}], 'classes': [{'title': 'Change in Subject VAS for CD symptoms', 'categories': [{'measurements': [{'value': '-24.2', 'spread': '29.5', 'groupId': 'OG000'}, {'value': '-6.7', 'spread': '20.8', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Subject VAS for CD symptoms', 'categories': [{'measurements': [{'value': '67.7', 'spread': '19.7', 'groupId': 'OG000'}, {'value': '63.6', 'spread': '18.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 Subject VAS for CD symptoms', 'categories': [{'measurements': [{'value': '44.3', 'spread': '24.4', 'groupId': 'OG000'}, {'value': '55.7', 'spread': '20.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-15.2', 'ciLowerLimit': '-24.0', 'ciUpperLimit': '-6.4', 'pValueComment': 'A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\\<0.05 was considered significant.', 'estimateComment': 'Analysis at baseline (and on change at Week 4) excludes 4 subjects (and 13 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Treatment group, baseline Subject VAS symptom score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. There were 5 subjects on Dysport and 8 on placebo who were not assessed on the change in subject VAS score for CD symptoms at Week 4. There was no imputation of missing VAS scores, so these 13 subjects were not taken into account.'}, {'type': 'SECONDARY', 'title': 'Investigator VAS for CD Symptom Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport 500 Units', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}], 'classes': [{'title': 'Change in Investigator VAS for CD symptoms', 'categories': [{'measurements': [{'value': '-23.1', 'spread': '22.1', 'groupId': 'OG000'}, {'value': '-9.1', 'spread': '20.2', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Investigator VAS for CD symptoms', 'categories': [{'measurements': [{'value': '62.3', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '65.3', 'spread': '18.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 Investigator VAS for CD symptoms', 'categories': [{'measurements': [{'value': '40.3', 'spread': '21.7', 'groupId': 'OG000'}, {'value': '56.8', 'spread': '21.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-14.2', 'ciLowerLimit': '-22.3', 'ciUpperLimit': '-6.1', 'pValueComment': 'A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\\<0.05 was considered significant.', 'estimateComment': 'Analysis at baseline (and on change at Week 4) excludes 3 subjects (and 8 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Treatment group, baseline Investigator VAS CD symptom score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4', 'description': 'The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on intention to treat population which consisted of 55 subjects receiving Dysport and 61 Placebo. There were 3 subjects for Dysport and 5 for placebo who were not assessed on the change in investigator VAS score at Week 4. As there was no imputation of missing VAS scores, these 8 subjects were not taken into account.'}, {'type': 'SECONDARY', 'title': 'Subject VAS for CD Symptom Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport 500 Units', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}], 'classes': [{'title': 'Change in subject VAS for CD symptoms', 'categories': [{'measurements': [{'value': '-24.6', 'spread': '30.0', 'groupId': 'OG000'}, {'value': '-5.4', 'spread': '25.4', 'groupId': 'OG001'}]}]}, {'title': 'Baseline subject VAS for CD symptoms', 'categories': [{'measurements': [{'value': '67.7', 'spread': '19.7', 'groupId': 'OG000'}, {'value': '63.6', 'spread': '18.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 subject VAS for CD symptoms', 'categories': [{'measurements': [{'value': '44.7', 'spread': '24.9', 'groupId': 'OG000'}, {'value': '57.8', 'spread': '27.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-16.95', 'ciLowerLimit': '-25.8', 'ciUpperLimit': '-8.1', 'pValueComment': 'A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\\<0.05 was considered significant.', 'estimateComment': 'Analysis at baseline (and on change at Week 8) excludes 4 subjects (and 4 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Treatment group, baseline Subject VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 8', 'description': 'The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100mm (worst possible symptoms).', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 8 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 4 patients on placebo with missing baseline and Week 4 values.'}, {'type': 'SECONDARY', 'title': "Investigator's VAS for CD Symptom Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport 500 Units', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}], 'classes': [{'title': 'Change in Investigator VAS for CD symptoms', 'categories': [{'measurements': [{'value': '-20.5', 'spread': '22.7', 'groupId': 'OG000'}, {'value': '-5.0', 'spread': '21.3', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Investigator VAS for CD symptoms', 'categories': [{'measurements': [{'value': '62.3', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '65.3', 'spread': '18.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 Investigator VAS for CD symptoms', 'categories': [{'measurements': [{'value': '40.8', 'spread': '22.3', 'groupId': 'OG000'}, {'value': '60.8', 'spread': '24.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-16.0', 'ciLowerLimit': '-24.2', 'ciUpperLimit': '-7.8', 'pValueComment': 'A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\\<0.05 was considered significant.', 'estimateComment': 'Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 3 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Treatment group, baseline Investigator VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 8', 'description': 'The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 8 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 3 patients with missing baseline and Week 4 values.'}, {'type': 'SECONDARY', 'title': 'Subject VAS for CD Symptom Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport 500 Units', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}], 'classes': [{'title': 'Change in subject VAS for CD symptoms', 'categories': [{'measurements': [{'value': '-14.4', 'spread': '25.2', 'groupId': 'OG000'}, {'value': '-4.6', 'spread': '23.3', 'groupId': 'OG001'}]}]}, {'title': 'Baseline subject VAS for CD symptoms', 'categories': [{'measurements': [{'value': '67.7', 'spread': '19.7', 'groupId': 'OG000'}, {'value': '63.6', 'spread': '18.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 subject VAS for CD symptoms', 'categories': [{'measurements': [{'value': '55.4', 'spread': '25.5', 'groupId': 'OG000'}, {'value': '58.2', 'spread': '25.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-11.05', 'ciLowerLimit': '-19.0', 'ciUpperLimit': '-3.1', 'pValueComment': 'A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\\<0.05 was considered significant.', 'estimateComment': 'Analysis at baseline (and on change at Week 12) excludes 4 subjects (and 4 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Treatment group, baseline Subject VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 12', 'description': 'The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 12 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 4 patients on placebo with missing baseline, Week 4 and Week 8 values.'}, {'type': 'SECONDARY', 'title': "Investigator's VAS for CD Symptom Assessment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport 500 Units', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}], 'classes': [{'title': 'Change in Investigator VAS for CD symptoms', 'categories': [{'measurements': [{'value': '-8.5', 'spread': '18.9', 'groupId': 'OG000'}, {'value': '-5.8', 'spread': '15.8', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Investigator VAS for CD symptoms', 'categories': [{'measurements': [{'value': '62.3', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '65.3', 'spread': '18.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 Investigator VAS for CD symptoms', 'categories': [{'measurements': [{'value': '54.8', 'spread': '20.8', 'groupId': 'OG000'}, {'value': '60.0', 'spread': '21.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.028', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-7.05', 'ciLowerLimit': '-13.3', 'ciUpperLimit': '-0.8', 'pValueComment': 'A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\\<0.05 was considered significant.', 'estimateComment': 'Analysis at baseline (and on change at Week 12) excludes 3 subjects (and 3 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Treatment group, baseline Investigator VAS Pain score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 12', 'description': 'The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms) to 100 mm (worst possible symptoms).', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. Missing assessments at Week 12 were imputed using Last Observation Carried Forward (LOCF) methodology. There was no imputation for 3 patients with missing baseline, Week 4 and Week 8 values.'}, {'type': 'SECONDARY', 'title': 'SF-36 Mental Health Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport 500 Units', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}], 'classes': [{'title': 'Change in SF-36 Mental health summary Score', 'categories': [{'measurements': [{'value': '4.11', 'spread': '9.18', 'groupId': 'OG000'}, {'value': '2.48', 'spread': '8.12', 'groupId': 'OG001'}]}]}, {'title': 'Baseline SF-36 Mental health summary Score', 'categories': [{'measurements': [{'value': '44.52', 'spread': '10.41', 'groupId': 'OG000'}, {'value': '43.31', 'spread': '11.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 SF-36 Mental health summary Score', 'categories': [{'measurements': [{'value': '49.00', 'spread': '8.69', 'groupId': 'OG000'}, {'value': '43.41', 'spread': '12.30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.061', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '3.65', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '7.47', 'pValueComment': 'A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\\<0.05 was considered significant.', 'estimateComment': 'Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 37 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Treatment group, baseline SF-36 mental health summary score, center and previous treatment by botulinum toxin or not were fitted in the ANCOVA model.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Mental Health Summary Score is derived from four individual domains (vitality, social functioning, role limitations due to emotional problems and mental health).', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. There were 13 subjects on Dysport and 24 on placebo who were not assessed on the change in mental health summary at Week 8. There was no imputation of missing scores, so these 37 subjects were not taken into account.'}, {'type': 'SECONDARY', 'title': 'SF-36 Physical Health Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport 500 Units', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}], 'classes': [{'title': 'Change in SF-36 Physical health summary score', 'categories': [{'measurements': [{'value': '4.37', 'spread': '5.46', 'groupId': 'OG000'}, {'value': '-0.64', 'spread': '6.41', 'groupId': 'OG001'}]}]}, {'title': 'Baseline SF-36 Physical health summary score', 'categories': [{'measurements': [{'value': '39.42', 'spread': '8.84', 'groupId': 'OG000'}, {'value': '43.18', 'spread': '7.89', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 SF-36 Physical health summary score', 'categories': [{'measurements': [{'value': '43.70', 'spread': '8.76', 'groupId': 'OG000'}, {'value': '42.49', 'spread': '8.84', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '4.66', 'ciLowerLimit': '1.73', 'ciUpperLimit': '7.58', 'pValueComment': 'A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\\<0.05 was considered significant.', 'estimateComment': 'Analysis at baseline (and on change at Week 8) excludes 3 subjects (and 37 subjects respectively) of ITT population who were not assessed. Mean difference=difference in adjusted least squares mean (Dysport-placebo)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Treatment group, baseline SF-36 physical health summary score, center and previous treatment by botulinum toxin or not were fitted in ANCOVA model.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Physical Health Summary Score is derived from four individual domains (physical functioning, role physical, bodily pain and general health).', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on intention to treat population which consisted of 55 subjects on Dysport and 61 on Placebo. There were 13 subjects on Dysport and 24 on placebo who were not assessed on the change in physical health summary at Week 8. There was no imputation of missing scores, so these 37 subjects were not taken into account.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Considered by the Investigator to be Overall Treatment Successes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dysport 500 Units', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '7.206', 'ciLowerLimit': '3.01', 'ciUpperLimit': '17.26', 'pValueComment': 'A hierarchical testing procedure was applied for the primary and secondary outcome measures ranked in the order of priority listed. At each step of the hierarchical testing procedure, there was one comparison and p\\<0.05 was considered significant.', 'groupDescription': 'The number of participants considered treatment successes was analysed using a logistic model with treatment, strata (naive or non-naive) and center as factors in the model.', 'statisticalMethod': 'odds ratio', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The odds ratio represents the odds of success on Dysport versus Placebo stratified for strata and country'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'The number of participants considered to be overall treatment successes by the investigator at week 12 was assessed.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on intention to treat population which consisted of 55 participants on Dysport and 61 on Placebo.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dysport 500 Units', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'PI & Subject Schedule Conflicts', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'No longer wanted to do blood draws', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were recruited at 16 centres in the USA and 4 centres in Russia from October 2005 until September 2006'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dysport 500 Units', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.9', 'spread': '13.4', 'groupId': 'BG000'}, {'value': '53.9', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '53.0', 'spread': '12.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-15', 'studyFirstSubmitDate': '2005-11-22', 'resultsFirstSubmitDate': '2010-01-06', 'studyFirstSubmitQcDate': '2005-11-22', 'lastUpdatePostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-04-20', 'studyFirstPostDateStruct': {'date': '2005-11-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)', 'timeFrame': 'Baseline and Week 4', 'description': 'TWSTRS is comprised of three different components which are severity, disability \\& pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.'}], 'secondaryOutcomes': [{'measure': 'Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)', 'timeFrame': 'Baseline and Week 8', 'description': 'TWSTRS is comprised of three different components which are severity, disability \\& pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.'}, {'measure': 'Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score', 'timeFrame': 'Baseline and Week 12', 'description': 'TWSTRS is comprised of three different components which are severity, disability \\& pain. There is an ordinal scale for each component and the score range for each is the following: for severity from 0 (absence of severity) to 35 (max severity), for disability from 0 (no disability) to 30 (max disability) and for pain from 0 (no pain) to 20 (max pain). TWSTRS total score is the sum of the 3 component scores, with a range from 0 to a maximum of 85. The change in TWSTRS total score is the score at week 4 minus the score at baseline.'}, {'measure': 'Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment', 'timeFrame': 'Baseline and Week 4', 'description': 'The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).'}, {'measure': 'Investigator VAS for CD Symptom Assessment', 'timeFrame': 'Baseline and Week 4', 'description': 'The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).'}, {'measure': 'Subject VAS for CD Symptom Assessment', 'timeFrame': 'Baseline and Week 8', 'description': 'The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100mm (worst possible symptoms).'}, {'measure': "Investigator's VAS for CD Symptom Assessment", 'timeFrame': 'Baseline and week 8', 'description': 'The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).'}, {'measure': 'Subject VAS for CD Symptom Assessment', 'timeFrame': 'Baseline and week 12', 'description': 'The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms)to 100 mm (worst possible symptoms).'}, {'measure': "Investigator's VAS for CD Symptom Assessment", 'timeFrame': 'Baseline and week 12', 'description': 'The assessment was a continuous 100 mm horizonal line with a scale of 0 mm (no symptoms) to 100 mm (worst possible symptoms).'}, {'measure': 'SF-36 Mental Health Summary Score', 'timeFrame': 'Week 8', 'description': 'SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Mental Health Summary Score is derived from four individual domains (vitality, social functioning, role limitations due to emotional problems and mental health).'}, {'measure': 'SF-36 Physical Health Summary Score', 'timeFrame': 'Week 8', 'description': 'SF-36 is a Quality of Life scale comprising eight individual domains. The QoL score for each domain is on a scale from 0 (worst health possible) to 100 (best health possible). SF-36 Physical Health Summary Score is derived from four individual domains (physical functioning, role physical, bodily pain and general health).'}, {'measure': 'Number of Participants Considered by the Investigator to be Overall Treatment Successes', 'timeFrame': 'Week 12', 'description': 'The number of participants considered to be overall treatment successes by the investigator at week 12 was assessed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cervical Dystonia']}, 'referencesModule': {'references': [{'pmid': '20359934', 'type': 'RESULT', 'citation': 'Truong D, Brodsky M, Lew M, Brashear A, Jankovic J, Molho E, Orlova O, Timerbaeva S; Global Dysport Cervical Dystonia Study Group. Long-term efficacy and safety of botulinum toxin type A (Dysport) in cervical dystonia. Parkinsonism Relat Disord. 2010 Jun;16(5):316-23. doi: 10.1016/j.parkreldis.2010.03.002. Epub 2010 Mar 31.'}, {'pmid': '25324317', 'type': 'DERIVED', 'citation': 'Mordin M, Masaquel C, Abbott C, Copley-Merriman C. Factors affecting the health-related quality of life of patients with cervical dystonia and impact of treatment with abobotulinumtoxinA (Dysport): results from a randomised, double-blind, placebo-controlled study. BMJ Open. 2014 Oct 16;4(10):e005150. doi: 10.1136/bmjopen-2014-005150.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport manufactured at a new manufacturing facility in Europe.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cervical dystonia with at least 18 months since onset, and previously untreated with botulinum toxin or previously treated with botulinum toxin type A or B with a minimum interval of 16 weeks since the last injection and having returned at least to their usual pre-treatment status\n* TWSTRS severity, disability and total scores meeting the defined criteria at baseline\n\nExclusion Criteria:\n\n* Pure anterocollis or pure retrocollis\n* In apparent remission from cervical dystonia\n* Previous poor response to the last two botulinum toxin type A or type B treatments\n* Being treated with type B toxin due to lack of efficacy to type A toxin or have known neutralizing antibodies to type A toxin'}, 'identificationModule': {'nctId': 'NCT00257660', 'briefTitle': 'Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'A Phase III Multicentre, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Dysport® for the Treatment of Cervical Dystonia', 'orgStudyIdInfo': {'id': 'Y-47-52120-051'}, 'secondaryIdInfos': [{'id': '2005-000709-70', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Drug: abobotulinumtoxinA (Dysport®)', 'interventionNames': ['Biological: Botulinum toxin type A']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Botulinum toxin type A', 'type': 'BIOLOGICAL', 'otherNames': ['AbobotulinumtoxinA (Dysport®)'], 'description': '500 units', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '500 units', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "St. Joseph's Hospital and Medical Center", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': "Parkinson's and Movement Disorder Institute", 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC School of Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University Medical Center', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Beth Israel Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegeheny General', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwest', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Neuroscience', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '123367', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Scientific Research Institute of Neurology, RAMS', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '125047', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Clinic "Cecil Plus"', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '194354', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Municipal Multi-Speciality Hospital #2', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197022', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'St Petersburg Pavlov State Medical University', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'overallOfficials': [{'name': 'Ipsen Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/members/ourmembers/', 'timeFrame': 'Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.', 'ipdSharing': 'YES', 'description': 'Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.\n\nAny requests should be submitted to www.vivli.org for assessment by an independent scientific review board.', 'accessCriteria': "Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}