Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
Study NCT ID:
NCT02291861
Status:
COMPLETED
Last Update Posted:
2021-11-09
First Post:
2014-11-12
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Addressing Involuntary Movements in Tardive Dyskinesia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071057', 'term': 'Tardive Dyskinesia'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}], 'ancestors': [{'id': 'D004409', 'term': 'Dyskinesia, Drug-Induced'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000609690', 'term': 'deutetrabenazine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ustevatrials@tevapharm.com', 'phone': '215-591-3000', 'title': 'Director, Clinical Research', 'organization': 'Teva Branded Pharmaceutical Products, R&D Inc'}, 'certainAgreement': {'otherDetails': "Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 to Week 12', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo tablets taken twice daily for 12 weeks.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 14, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'SD-809 12 mg/Day', 'description': 'SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 9, 'seriousNumAtRisk': 74, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'SD-809 24 mg/Day', 'description': 'SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 9, 'seriousNumAtRisk': 73, 'deathsNumAffected': 1, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'SD-809 36 mg/Day', 'description': 'SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 10, 'seriousNumAtRisk': 74, 'deathsNumAffected': 1, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'seriousEvents': [{'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pancreatic mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Alcohol interaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Face injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Skeletal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Neuroendocrine carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Psychomotor hyperactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model For Repeated Measures (MMRM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets taken twice daily for 12 weeks.'}, {'id': 'OG001', 'title': 'SD-809 12 mg/Day', 'description': 'SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.'}, {'id': 'OG002', 'title': 'SD-809 24 mg/Day', 'description': 'SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.'}, {'id': 'OG003', 'title': 'SD-809 36 mg/Day', 'description': 'SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '0.42', 'groupId': 'OG001'}, {'value': '-3.2', 'spread': '0.45', 'groupId': 'OG002'}, {'value': '-3.3', 'spread': '0.42', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-3.09', 'ciUpperLimit': '-0.79', 'pValueComment': 'Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.', 'estimateComment': 'SD-809 - placebo', 'groupDescription': 'A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.\n\nThe primary endpoint compared the change in total motor AIMS score from baseline to week 12 between the SD-809 36 mg/day group and the placebo group.', 'statisticalMethod': 'mixed model for repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-3.00', 'ciUpperLimit': '-0.63', 'pValueComment': 'Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.', 'estimateComment': 'SD-809 - placebo', 'groupDescription': 'A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.\n\nThis key secondary endpoint compared the change in total motor AIMS score from baseline to week 12 between the SD-809 24 mg/day group and the placebo group, and is the third analysis in the fixed-sequence.', 'statisticalMethod': 'mixed model for repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.217', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.84', 'ciUpperLimit': '0.42', 'pValueComment': 'Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.', 'estimateComment': 'SD-809 - placebo', 'groupDescription': 'A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.\n\nThis key secondary endpoint compared the change in total motor AIMS score from baseline to week 12 between the SD-809 12 mg/day group and the placebo group, and is the fifth analysis in the fixed-sequence.', 'statisticalMethod': 'mixed model for repeated measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 0 (Baseline), Weeks 2, 4, 8 and 12', 'description': 'AIMS is an assessment tool used to detect and follow the severity of tardive dyskinesia (TD) over time. AIMS is composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders.\n\nThis outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement.\n\nMMRM with treatment group, visit, treatment group-by-visit interaction, and baseline use of dopamine receptor antagonist (DRAs) as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT Population (N=222) included all patients in the ITT Population with a baseline AIMS score ≥6 as assessed by central video rating, were randomized to treatment, received study drug, and had at least 1 postbaseline AIMS assessment. For this outcome, participants with baseline readings and during-study readings through Week 12 are included.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets taken twice daily for 12 weeks.'}, {'id': 'OG001', 'title': 'SD-809 12 mg/Day', 'description': 'SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.'}, {'id': 'OG002', 'title': 'SD-809 24 mg/Day', 'description': 'SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.'}, {'id': 'OG003', 'title': 'SD-809 36 mg/Day', 'description': 'SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '16.3', 'upperLimit': '38.4'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '18.5', 'upperLimit': '40.8'}, {'value': '49', 'groupId': 'OG002', 'lowerLimit': '35.6', 'upperLimit': '62.5'}, {'value': '44', 'groupId': 'OG003', 'lowerLimit': '31.4', 'upperLimit': '56.7'}]}]}], 'analyses': [{'pValue': '0.059', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.11', 'ciLowerLimit': '0.960', 'ciUpperLimit': '4.645', 'estimateComment': 'SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.', 'groupDescription': 'A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.\n\nThis key secondary endpoint compared the percentage of patients considered a treatment success at week 12 between the SD-809 36 mg/day group and the placebo group, and is the second analysis in the fixed-sequence.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The statistical test was a Cochran-Mantel-Haenszel (CMH) test stratified by baseline use of dopamine receptor antagonist (DRAs).'}, {'pValue': '0.014', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.71', 'ciLowerLimit': '1.211', 'ciUpperLimit': '6.052', 'estimateComment': 'SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.', 'groupDescription': 'A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.\n\nThis key secondary endpoint compared the percentage of patients considered a treatment success at week 12 between the SD-809 24 mg/day group and the placebo group, and is the fourth analysis in the fixed-sequence.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The statistical test was a CMH test stratified by baseline use of DRAs.'}, {'pValue': '0.734', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.509', 'ciUpperLimit': '2.610', 'estimateComment': 'SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.', 'groupDescription': 'A hierarchical (fixed-sequence) testing approach was used for the analysis of the primary and key secondary endpoints to maintain the experiment-wise type I error rate of 5%.\n\nThis key secondary endpoint compared the percentage of patients considered a treatment success at week 12 between the SD-809 12 mg/day group and the placebo group, and is the sixth (last) analysis in the fixed-sequence.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The statistical test was a CMH test stratified by baseline use of DRAs.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'The CGIC is a single-item questionnaire that asks the investigator to assess a patient\'s TD symptoms at specific visits after initiating therapy. The CGIC uses a 7 point Likert Scale, ranging from very much worse (-3) to very much improved (+3), to assess overall response to therapy.\n\nA treatment success was defined as "much improved" or "very much improved" at the week 12 visit.\n\nPatients whose status at week 12 was not known, as well as patients who were not "much improved" or "very much improved" at the week 12 visit, were considered treatment failures.\n\nThe success 95% confidence interval (CI) was calculated with the Wilson (score) confidence limits.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT Population (N=222) included all patients in the ITT Population with a baseline AIMS score ≥6 as assessed by central video rating, were randomized to treatment, received study drug, and had at least 1 postbaseline AIMS assessment.'}, {'type': 'SECONDARY', 'title': 'Change in the Modified Craniocervical Dystonia Questionnaire (mCDQ-24) Total Score From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets taken twice daily for 12 weeks.'}, {'id': 'OG001', 'title': 'SD-809 12 mg/Day', 'description': 'SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.'}, {'id': 'OG002', 'title': 'SD-809 24 mg/Day', 'description': 'SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.'}, {'id': 'OG003', 'title': 'SD-809 36 mg/Day', 'description': 'SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.1', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '-5.8', 'spread': '2.03', 'groupId': 'OG001'}, {'value': '-10.2', 'spread': '2.21', 'groupId': 'OG002'}, {'value': '-10.7', 'spread': '2.04', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.207', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.6', 'ciLowerLimit': '-9.18', 'ciUpperLimit': '2.00', 'pValueComment': '5% level of significance (2-sided)', 'estimateComment': 'SD-809 - placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The statistical model was an ANCOVA with treatment group and baseline use of DRAs as fixed effects and the baseline value as a covariate.'}, {'pValue': '0.281', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.1', 'ciLowerLimit': '-8.86', 'ciUpperLimit': '2.59', 'pValueComment': '5% level of significance (2-sided)', 'estimateComment': 'SD-809 - placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The statistical model was an ANCOVA with treatment group and baseline use of DRAs as fixed effects and the baseline value as a covariate.'}, {'pValue': '0.627', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '-4.10', 'ciUpperLimit': '6.79', 'pValueComment': '5% level of significance (2-sided)', 'estimateComment': 'SD-809 - placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The statistical model was an ANCOVA with treatment group and baseline use of DRAs as fixed effects and the baseline value as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 0 (Baseline), Week 12', 'description': 'The CDQ-24 is a disease-specific quality of life questionnaire developed for use in patients with craniocervical dystonia, including both cervical dystonia (CD) and blepharospasm (BPS). The CDQ 24 was modified such that the questions focus more directly on the impact of TD (as opposed to CD/BPS) on quality of life.\n\nThe following domains are evaluated in the mCDQ-24: stigma, emotional well-being, pain, activities of daily living, and social/family life. Each of the 24 questions were rated by patients on a scale of 0=no impairment to 4=severest impairment for a total scale of 0 - 96. Negative change from baseline scores indicate improvement.\n\nFor patients with missing data at week 12, the baseline or last available value was used as the week 12 value.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT Population (N=222) included all patients in the ITT Population with a baseline AIMS score ≥6 as assessed by central video rating, were randomized to treatment, received study drug, and had at least 1 postbaseline AIMS assessment. One SD-809 12 mg/day participant was missing a baseline mCDQ-24.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Patient Global Impression of Change (PGIC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets taken twice daily for 12 weeks.'}, {'id': 'OG001', 'title': 'SD-809 12 mg/Day', 'description': 'SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.'}, {'id': 'OG002', 'title': 'SD-809 24 mg/Day', 'description': 'SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.'}, {'id': 'OG003', 'title': 'SD-809 36 mg/Day', 'description': 'SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000', 'lowerLimit': '20.6', 'upperLimit': '43.8'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '14.4', 'upperLimit': '35.4'}, {'value': '45', 'groupId': 'OG002', 'lowerLimit': '31.9', 'upperLimit': '58.7'}, {'value': '40', 'groupId': 'OG003', 'lowerLimit': '28.1', 'upperLimit': '53.2'}]}]}], 'analyses': [{'pValue': '0.296', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.51', 'ciLowerLimit': '0.694', 'ciUpperLimit': '3.285', 'pValueComment': '5% level of significance (2-sided)', 'estimateComment': 'SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The statistical test was a CMH test stratified by baseline use of DRAs.'}, {'pValue': '0.134', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.82', 'ciLowerLimit': '0.826', 'ciUpperLimit': '3.994', 'pValueComment': '5% level of significance (2-sided)', 'estimateComment': 'SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The statistical test was a CMH test stratified by baseline use of DRAs.'}, {'pValue': '0.372', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.302', 'ciUpperLimit': '1.563', 'pValueComment': '5% level of significance (2-sided)', 'estimateComment': 'SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The statistical test was a CMH test stratified by baseline use of DRAs.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'The PGIC is a single-item questionnaire that asks the patient to assess their TD symptoms at specific visits after initiating therapy. The PGIC uses a 7 point Likert Scale, ranging from very much worse (-3) to very much improved (+3), to assess overall response to therapy. A treatment success was defined as "much improved" or "very much improved" at the week 12 visit.\n\nPatients whose status at week 12 was not known, as well as patients who were not "much improved" or "very much improved" at the week 12 visit, were considered treatment failures. The success 95% CI was calculated with the Wilson (score) confidence limits.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Had a 50% or Greater Reduction in Total Motor Abnormal Involuntary Movement Scale (AIMS) From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets taken twice daily for 12 weeks.'}, {'id': 'OG001', 'title': 'SD-809 12 mg/Day', 'description': 'SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.'}, {'id': 'OG002', 'title': 'SD-809 24 mg/Day', 'description': 'SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.'}, {'id': 'OG003', 'title': 'SD-809 36 mg/Day', 'description': 'SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '22.9'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '24.2'}, {'value': '35', 'groupId': 'OG002', 'lowerLimit': '22.9', 'upperLimit': '48.7'}, {'value': '33', 'groupId': 'OG003', 'lowerLimit': '21.8', 'upperLimit': '45.9'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.80', 'ciLowerLimit': '1.395', 'ciUpperLimit': '10.359', 'pValueComment': '5% level of significance (2-sided)', 'estimateComment': 'SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The statistical test was a CMH test stratified by baseline use of DRAs.'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.96', 'ciLowerLimit': '1.460', 'ciUpperLimit': '10.716', 'pValueComment': '5% level of significance (2-sided)', 'estimateComment': 'SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The statistical test was a CMH test stratified by baseline use of DRAs.'}, {'pValue': '0.829', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.383', 'ciUpperLimit': '3.316', 'pValueComment': '5% level of significance (2-sided)', 'estimateComment': 'SD-809/placebo The odds ratio was the Mantel-Haenszel estimate of the common odds ratio.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The statistical test was a CMH test stratified by baseline use of DRAs.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (Baseline), Week 12', 'description': 'Responders who had a 50% or greater improvement in total motor modified AIMS at Week 12 as compared to baseline were reported as a percentage of participants with an outcome at Week 12. The responder 95% CI is calculated with the Wilson (score) confidence limits.\n\nAIMS is an assessment tool used to detect and follow the severity of TD over time. AIMS is composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders.\n\nThis outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population of participants. Participants with missing Week 12 data were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model for Repeated Measures (MMRM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets taken twice daily for 12 weeks.'}, {'id': 'OG001', 'title': 'SD-809 12 mg/Day', 'description': 'SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.'}, {'id': 'OG002', 'title': 'SD-809 24 mg/Day', 'description': 'SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.'}, {'id': 'OG003', 'title': 'SD-809 36 mg/Day', 'description': 'SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.6', 'spread': '4.32', 'groupId': 'OG000'}, {'value': '-20.0', 'spread': '4.34', 'groupId': 'OG001'}, {'value': '-31.9', 'spread': '4.73', 'groupId': 'OG002'}, {'value': '-33.1', 'spread': '4.38', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.5', 'ciLowerLimit': '-33.44', 'ciUpperLimit': '-9.52', 'pValueComment': '5% level of significance (2-sided). Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.', 'estimateComment': 'SD-809 - placebo', 'statisticalMethod': 'mixed model for repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.2', 'ciLowerLimit': '-32.57', 'ciUpperLimit': '-7.92', 'pValueComment': '5% level of significance (2-sided). Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.', 'estimateComment': 'SD-809 - placebo', 'statisticalMethod': 'mixed model for repeated measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.160', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.4', 'ciLowerLimit': '-20.15', 'ciUpperLimit': '3.34', 'pValueComment': '5% level of significance (2-sided). Treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.', 'estimateComment': 'SD-809 - placebo', 'statisticalMethod': 'mixed model for repeated measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 0 (Baseline), Weeks 2, 4, 8 and 12', 'description': 'AIMS is an assessment tool used to detect and follow the severity of TD over time. AIMS is composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders.\n\nThis outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement.\n\nMMRM with treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.', 'unitOfMeasure': 'percentage of baseline', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT Population (N=222) included all patients in the ITT Population with a baseline AIMS score ≥6 as assessed by central video rating, were randomized to treatment, received study drug, and had at least 1 postbaseline AIMS assessment. For this outcome, participants with baseline readings and during-study readings through Week 12 are included.'}, {'type': 'SECONDARY', 'title': 'Cumulative Percentage of Responders Based on Change in in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Recorded in Incremental Steps of 10 Percentage Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets taken twice daily for 12 weeks.'}, {'id': 'OG001', 'title': 'SD-809 12 mg/Day', 'description': 'SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.'}, {'id': 'OG002', 'title': 'SD-809 24 mg/Day', 'description': 'SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.'}, {'id': 'OG003', 'title': 'SD-809 36 mg/Day', 'description': 'SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.'}], 'classes': [{'title': '10% Improvement', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '37.5', 'upperLimit': '62.5'}, {'value': '62', 'groupId': 'OG001', 'lowerLimit': '49.0', 'upperLimit': '72.9'}, {'value': '67', 'groupId': 'OG002', 'lowerLimit': '53.4', 'upperLimit': '78.8'}, {'value': '71', 'groupId': 'OG003', 'lowerLimit': '57.9', 'upperLimit': '81.2'}]}]}, {'title': '20% Improvement', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '28.1', 'upperLimit': '52.5'}, {'value': '47', 'groupId': 'OG001', 'lowerLimit': '34.6', 'upperLimit': '59.1'}, {'value': '59', 'groupId': 'OG002', 'lowerLimit': '45.2', 'upperLimit': '71.8'}, {'value': '60', 'groupId': 'OG003', 'lowerLimit': '46.8', 'upperLimit': '71.9'}]}]}, {'title': '30% Improvement', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000', 'lowerLimit': '20.6', 'upperLimit': '43.8'}, {'value': '32', 'groupId': 'OG001', 'lowerLimit': '21.3', 'upperLimit': '44.2'}, {'value': '49', 'groupId': 'OG002', 'lowerLimit': '35.6', 'upperLimit': '62.5'}, {'value': '49', 'groupId': 'OG003', 'lowerLimit': '36.4', 'upperLimit': '61.9'}]}]}, {'title': '40% Improvement', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '8.4', 'upperLimit': '26.9'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '14.4', 'upperLimit': '35.4'}, {'value': '45', 'groupId': 'OG002', 'lowerLimit': '31.9', 'upperLimit': '58.7'}, {'value': '40', 'groupId': 'OG003', 'lowerLimit': '28.1', 'upperLimit': '53.2'}]}]}, {'title': '50% Improvement', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '22.9'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '6.9', 'upperLimit': '24.2'}, {'value': '35', 'groupId': 'OG002', 'lowerLimit': '22.9', 'upperLimit': '48.7'}, {'value': '33', 'groupId': 'OG003', 'lowerLimit': '21.8', 'upperLimit': '45.9'}]}]}, {'title': '60% Improvement', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '14.1'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '15.9'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '11.5', 'upperLimit': '33.6'}, {'value': '18', 'groupId': 'OG003', 'lowerLimit': '10.2', 'upperLimit': '30.3'}]}]}, {'title': '70% Improvement', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '9.2'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '11.5'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '4.6', 'upperLimit': '24.8'}, {'value': '16', 'groupId': 'OG003', 'lowerLimit': '7.8', 'upperLimit': '28.8'}]}]}, {'title': '80% Improvement', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '9.2'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.9'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '10.9'}, {'value': '13', 'groupId': 'OG003', 'lowerLimit': '5.3', 'upperLimit': '24.5'}]}]}, {'title': '90% Improvement', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '9.2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '6.0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '7.3'}, {'value': '5', 'groupId': 'OG003', 'lowerLimit': '1.1', 'upperLimit': '15.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (Baseline), Week 12', 'description': 'AIMS is an assessment tool used to detect and follow the severity of TD over time, composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders.\n\nThis outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement.\n\nParticipants with missing data are classified as non-responders. The responder 95% CI is calculated with the Wilson (score) confidence limits. If any of the expected cell counts are \\< 5, exact Clopper Pearson limits are presented.\n\nData report the percentage of participants who responded to the percentage improvement indicated in each row.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT Population (N=222) included all patients in the ITT Population with a baseline AIMS score ≥6 as assessed by central video rating, were randomized to treatment, received study drug, and had at least 1 postbaseline AIMS assessment.'}, {'type': 'SECONDARY', 'title': 'Participants With Adverse Events During the Overall Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo tablets taken twice daily for 12 weeks.'}, {'id': 'OG001', 'title': 'SD-809 12 mg/Day', 'description': 'SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.'}, {'id': 'OG002', 'title': 'SD-809 24 mg/Day', 'description': 'SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.'}, {'id': 'OG003', 'title': 'SD-809 36 mg/Day', 'description': 'SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.'}], 'classes': [{'title': 'Overall Treatment Period: any AE', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}]}, {'title': 'Overall Treatment Period: SAE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Overall Treatment Period: Severe AE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Overall Treatment Period: treatment-related AE', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'Dose reduction because of AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Dose suspension because of AE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Withdrawn from study because of AE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Week 12', 'description': 'An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator and includes possibly, probably and definitely related categories. Serious AEs (SAE) include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population was a subset of randomized participants and included all patients who were administered study drug (N=293).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo tablets taken twice daily for 12 weeks.'}, {'id': 'FG001', 'title': 'SD-809 12 mg/Day', 'description': 'SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.'}, {'id': 'FG002', 'title': 'SD-809 24 mg/Day', 'description': 'SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.'}, {'id': 'FG003', 'title': 'SD-809 36 mg/Day', 'description': 'SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '74'}, {'groupId': 'FG003', 'numSubjects': '75'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '74'}, {'groupId': 'FG002', 'numSubjects': '73'}, {'groupId': 'FG003', 'numSubjects': '74'}]}, {'type': 'Modified Intent to Treat Pop (mITT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '49'}, {'groupId': 'FG003', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '67'}, {'groupId': 'FG002', 'numSubjects': '65'}, {'groupId': 'FG003', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was performed at 75 study centers (38 in the US, 19 in Poland, 7 in Hungary, 6 in the Czech Republic, 3 in Slovakia, and 2 in Germany) by 75 investigators; 298 patients were enrolled.', 'preAssignmentDetails': 'Participants were randomly assigned in a 1:1:1:1 ratio to receive 1 of 3 fixed-dose regimens of SD-809 (deutetrabenazine) or placebo following a screening period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}, {'value': '293', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo tablets taken twice daily for 12 weeks.'}, {'id': 'BG001', 'title': 'SD-809 12 mg/Day', 'description': 'SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.'}, {'id': 'BG002', 'title': 'SD-809 24 mg/Day', 'description': 'SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.'}, {'id': 'BG003', 'title': 'SD-809 36 mg/Day', 'description': 'SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}, {'value': '293', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '54.6', 'spread': '12.06', 'groupId': 'BG000'}, {'value': '57.0', 'spread': '9.95', 'groupId': 'BG001'}, {'value': '55.6', 'spread': '11.34', 'groupId': 'BG002'}, {'value': '58.3', 'spread': '11.55', 'groupId': 'BG003'}, {'value': '56.4', 'spread': '11.27', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}, {'value': '293', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '162', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '131', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}, {'value': '293', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}, {'value': '232', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}, {'value': '293', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}, {'title': 'Not hispanic or latino', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '262', 'groupId': 'BG004'}]}, {'title': 'Not reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}, {'value': '293', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '82.8', 'spread': '18.51', 'groupId': 'BG000'}, {'value': '80.8', 'spread': '21.00', 'groupId': 'BG001'}, {'value': '86.8', 'spread': '18.79', 'groupId': 'BG002'}, {'value': '78.5', 'spread': '17.56', 'groupId': 'BG003'}, {'value': '82.2', 'spread': '19.16', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}, {'value': '293', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '168.3', 'spread': '9.25', 'groupId': 'BG000'}, {'value': '167.7', 'spread': '10.68', 'groupId': 'BG001'}, {'value': '168.7', 'spread': '9.39', 'groupId': 'BG002'}, {'value': '167.6', 'spread': '10.55', 'groupId': 'BG003'}, {'value': '168.1', 'spread': '9.96', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}, {'value': '293', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '29.18', 'spread': '6.128', 'groupId': 'BG000'}, {'value': '28.69', 'spread': '6.814', 'groupId': 'BG001'}, {'value': '30.64', 'spread': '7.021', 'groupId': 'BG002'}, {'value': '27.99', 'spread': '6.178', 'groupId': 'BG003'}, {'value': '29.12', 'spread': '6.587', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Education Level', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}, {'value': '293', 'groupId': 'BG004'}]}], 'categories': [{'title': '<= 12 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '167', 'groupId': 'BG004'}]}, {'title': '> 12 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '126', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Time Since Tardive Dyskinesia (TD) Diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}, {'value': '293', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '6.03', 'spread': '5.353', 'groupId': 'BG000'}, {'value': '5.49', 'spread': '5.426', 'groupId': 'BG001'}, {'value': '4.98', 'spread': '6.034', 'groupId': 'BG002'}, {'value': '5.89', 'spread': '5.342', 'groupId': 'BG003'}, {'value': '5.60', 'spread': '5.532', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Motor Abnormal Involuntary Movement Scale (AIMS) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}, {'value': '293', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '8.5', 'spread': '3.28', 'groupId': 'BG000'}, {'value': '8.6', 'spread': '3.13', 'groupId': 'BG001'}, {'value': '7.7', 'spread': '3.51', 'groupId': 'BG002'}, {'value': '8.6', 'spread': '3.84', 'groupId': 'BG003'}, {'value': '8.4', 'spread': '3.46', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and scored items.\n\nTotal Motor assessment sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia. Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Modified Craniocervical Dystonia Questionnaire (mCDQ-24)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}, {'value': '292', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '40.5', 'spread': '19.88', 'groupId': 'BG000'}, {'value': '37.2', 'spread': '20.15', 'groupId': 'BG001'}, {'value': '34.4', 'spread': '19.59', 'groupId': 'BG002'}, {'value': '34.9', 'spread': '18.34', 'groupId': 'BG003'}, {'value': '36.7', 'spread': '19.55', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The CDQ-24 is a disease-specific quality of life questionnaire developed for use in patients with craniocervical dystonia, including both cervical dystonia (CD) and blepharospasm (BPS). The CDQ 24 was modified such that the questions focus more directly on the impact of TD (as opposed to CD/BPS) on quality of life. Each of the 24 questions was rated by patients on a scale of 0=no impairment to 4=severest impairment for a total scale of 0 - 96.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'One participant in the SD-809 12 mg/day group was missing a baseline mCDQ-24 total score.'}, {'title': 'Baseline Use of a Dopamine Receptor Antagonist (DRA)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}, {'value': '293', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '222', 'groupId': 'BG004'}]}, {'title': 'No', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The randomization was stratified by baseline use of DRA (currently taking versus not currently taking a DRA).', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Safety Population was a subset of randomized participants and included all patients who were administered study drug (N=293).'}}, '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': 298}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2016-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-05', 'studyFirstSubmitDate': '2014-11-12', 'resultsFirstSubmitDate': '2018-03-15', 'studyFirstSubmitQcDate': '2014-11-12', 'lastUpdatePostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-15', 'studyFirstPostDateStruct': {'date': '2014-11-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model For Repeated Measures (MMRM)', 'timeFrame': 'Day 0 (Baseline), Weeks 2, 4, 8 and 12', 'description': 'AIMS is an assessment tool used to detect and follow the severity of tardive dyskinesia (TD) over time. AIMS is composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders.\n\nThis outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement.\n\nMMRM with treatment group, visit, treatment group-by-visit interaction, and baseline use of dopamine receptor antagonist (DRAs) as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC)', 'timeFrame': 'Week 12', 'description': 'The CGIC is a single-item questionnaire that asks the investigator to assess a patient\'s TD symptoms at specific visits after initiating therapy. The CGIC uses a 7 point Likert Scale, ranging from very much worse (-3) to very much improved (+3), to assess overall response to therapy.\n\nA treatment success was defined as "much improved" or "very much improved" at the week 12 visit.\n\nPatients whose status at week 12 was not known, as well as patients who were not "much improved" or "very much improved" at the week 12 visit, were considered treatment failures.\n\nThe success 95% confidence interval (CI) was calculated with the Wilson (score) confidence limits.'}, {'measure': 'Change in the Modified Craniocervical Dystonia Questionnaire (mCDQ-24) Total Score From Baseline to Week 12', 'timeFrame': 'Day 0 (Baseline), Week 12', 'description': 'The CDQ-24 is a disease-specific quality of life questionnaire developed for use in patients with craniocervical dystonia, including both cervical dystonia (CD) and blepharospasm (BPS). The CDQ 24 was modified such that the questions focus more directly on the impact of TD (as opposed to CD/BPS) on quality of life.\n\nThe following domains are evaluated in the mCDQ-24: stigma, emotional well-being, pain, activities of daily living, and social/family life. Each of the 24 questions were rated by patients on a scale of 0=no impairment to 4=severest impairment for a total scale of 0 - 96. Negative change from baseline scores indicate improvement.\n\nFor patients with missing data at week 12, the baseline or last available value was used as the week 12 value.'}, {'measure': 'Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Patient Global Impression of Change (PGIC)', 'timeFrame': 'Week 12', 'description': 'The PGIC is a single-item questionnaire that asks the patient to assess their TD symptoms at specific visits after initiating therapy. The PGIC uses a 7 point Likert Scale, ranging from very much worse (-3) to very much improved (+3), to assess overall response to therapy. A treatment success was defined as "much improved" or "very much improved" at the week 12 visit.\n\nPatients whose status at week 12 was not known, as well as patients who were not "much improved" or "very much improved" at the week 12 visit, were considered treatment failures. The success 95% CI was calculated with the Wilson (score) confidence limits.'}, {'measure': 'Percentage of Participants Who Had a 50% or Greater Reduction in Total Motor Abnormal Involuntary Movement Scale (AIMS) From Baseline to Week 12', 'timeFrame': 'Day 0 (Baseline), Week 12', 'description': 'Responders who had a 50% or greater improvement in total motor modified AIMS at Week 12 as compared to baseline were reported as a percentage of participants with an outcome at Week 12. The responder 95% CI is calculated with the Wilson (score) confidence limits.\n\nAIMS is an assessment tool used to detect and follow the severity of TD over time. AIMS is composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders.\n\nThis outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement.'}, {'measure': 'Percent Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model for Repeated Measures (MMRM)', 'timeFrame': 'Day 0 (Baseline), Weeks 2, 4, 8 and 12', 'description': 'AIMS is an assessment tool used to detect and follow the severity of TD over time. AIMS is composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders.\n\nThis outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement.\n\nMMRM with treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.'}, {'measure': 'Cumulative Percentage of Responders Based on Change in in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Recorded in Incremental Steps of 10 Percentage Points', 'timeFrame': 'Day 0 (Baseline), Week 12', 'description': 'AIMS is an assessment tool used to detect and follow the severity of TD over time, composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders.\n\nThis outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement.\n\nParticipants with missing data are classified as non-responders. The responder 95% CI is calculated with the Wilson (score) confidence limits. If any of the expected cell counts are \\< 5, exact Clopper Pearson limits are presented.\n\nData report the percentage of participants who responded to the percentage improvement indicated in each row.'}, {'measure': 'Participants With Adverse Events During the Overall Treatment Period', 'timeFrame': 'Day 1 to Week 12', 'description': 'An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator and includes possibly, probably and definitely related categories. Serious AEs (SAE) include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dyskinesias', 'Movement Disorders', 'Central Nervous System Diseases', 'Nervous System Diseases', 'Neurologic Manifestations', 'Signs and Symptoms'], 'conditions': ['Tardive Dyskinesia']}, 'referencesModule': {'references': [{'pmid': '28668671', 'type': 'RESULT', 'citation': 'Anderson KE, Stamler D, Davis MD, Factor SA, Hauser RA, Isojarvi J, Jarskog LF, Jimenez-Shahed J, Kumar R, McEvoy JP, Ochudlo S, Ondo WG, Fernandez HH. Deutetrabenazine for treatment of involuntary movements in patients with tardive dyskinesia (AIM-TD): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Psychiatry. 2017 Aug;4(8):595-604. doi: 10.1016/S2215-0366(17)30236-5. Epub 2017 Jun 28.'}, {'pmid': '38557959', 'type': 'DERIVED', 'citation': 'Frank S, Anderson KE, Fernandez HH, Hauser RA, Claassen DO, Stamler D, Factor SA, Jimenez-Shahed J, Barkay H, Wilhelm A, Alexander JK, Chaijale N, Barash S, Savola JM, Gordon MF, Chen M. Safety of Deutetrabenazine for the Treatment of Tardive Dyskinesia and Chorea Associated with Huntington Disease. Neurol Ther. 2024 Jun;13(3):655-675. doi: 10.1007/s40120-024-00600-1. Epub 2024 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether fixed-doses of an investigational drug, SD-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive dyskinesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of using a dopamine receptor antagonist for at least 3 months\n* Clinical diagnosis of tardive dyskinesia and has had symptoms for at least 3 months prior to screening\n* Subjects with underlying psychiatric diagnosis are stable and have no change in psychoactive medications\n* Have a mental health provider and does not anticipate any changes to treatment regimen in the next 3 months\n* History of being compliant with prescribed medications\n* Able to swallow study drug whole\n* Be in good general health and is expected to attend all study visits and complete study assessments\n* Female subjects must not be pregnant and must agree to an acceptable method of contraception throughout the study\n\nExclusion Criteria:\n\n* Currently receiving medication for the treatment of tardive dyskinesia\n* Have a neurological condition other than tardive dyskinesia that may interfere with assessing the severity of dyskinesias\n* Have a serious untreated or undertreated psychiatric illness\n* Have recent history or presence of violent behavior\n* Have unstable or serious medical illness\n* Have evidence of hepatic impairment\n* Have evidence of renal impairment\n* Have known allergy to any component of SD-809 or tetrabenazine\n* Has participated in an investigational drug or device trial and received study drug or device within 30 days\n* Have acknowledged use of illicit drugs\n* Have a history of alcohol or substance abuse in the previous 12 months'}, 'identificationModule': {'nctId': 'NCT02291861', 'acronym': 'AIM-TD', 'briefTitle': 'Addressing Involuntary Movements in Tardive Dyskinesia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia', 'orgStudyIdInfo': {'id': 'SD-809-C-23'}, 'secondaryIdInfos': [{'id': '2014-003135-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablets taken twice daily for 12 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SD-809 12 mg/day', 'description': 'SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.', 'interventionNames': ['Drug: SD-809']}, {'type': 'EXPERIMENTAL', 'label': 'SD-809 24 mg/day', 'description': 'SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.', 'interventionNames': ['Drug: SD-809']}, {'type': 'EXPERIMENTAL', 'label': 'SD-809 36 mg/day', 'description': 'SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.', 'interventionNames': ['Drug: SD-809']}], 'interventions': [{'name': 'SD-809', 'type': 'DRUG', 'otherNames': ['deutetrabenzine', 'Austedo'], 'description': 'SD-809 tablets dose titrated for 4 weeks until target randomized dose is reached. The dose is maintained for an additional 8 weeks. Tablets were swallowed whole with water and taken with food.', 'armGroupLabels': ['SD-809 12 mg/day', 'SD-809 24 mg/day', 'SD-809 36 mg/day']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets taken twice daily for 12 weeks. Tablets were swallowed whole with water and taken with food.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35404', 'city': 'Tuscaloosa', 'state': 'Alabama', 'country': 'United States', 'facility': 'Teva Investigational Site 145', 'geoPoint': {'lat': 33.20984, 'lon': -87.56917}}, {'zip': '92804', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 107', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92805', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 108', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 123', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '92251', 'city': 'Imperial', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 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States', 'facility': 'Teva Investigational Site 169', 'geoPoint': {'lat': 37.97353, 'lon': -122.53109}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Teva Investigational Site 129', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Teva Investigational Site 139', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Teva Investigational Site 156', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 157', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 117', 'geoPoint': 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'country': 'United States', 'facility': 'Teva Investigational Site 155', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Teva Investigational Site 165', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Teva Investigational Site 131', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Teva Investigational Site 113', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Teva Investigational Site 164', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Teva Investigational Site 154', 'geoPoint': {'lat': 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