Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-02-03 @ 5:51 AM
Study NCT ID:
NCT02198794
Status:
COMPLETED
Last Update Posted:
2022-04-01
First Post:
2014-07-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Reducing Involuntary Movements in Participants With 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': 'USMedInfo@tevapharm.com', 'phone': '1-888-483-8279', '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': 'Baseline up to the end of follow-up (4 weeks after the last dose of study drug; mean exposure: up to approximately 866.1 days)', 'description': 'Adverse events were analyzed as one group combined for Parts A and B and as a separate group for Part C per planned analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A and Part B Participants', 'description': 'Participants received SD-809 orally BID starting at 12 mg/day, which was titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who declined to participate in Part B, continued at their stable dose of SD-809 BID up to Week 158. Participants who agreed to participate in Part B, received SD-809 or placebo matched to SD-809 for 1 week in randomized withdrawal period and thereafter received SD-809 (stable dose) for 12 weeks.', 'otherNumAtRisk': 337, 'deathsNumAtRisk': 337, 'otherNumAffected': 172, 'seriousNumAtRisk': 337, 'deathsNumAffected': 8, 'seriousNumAffected': 68}, {'id': 'EG001', 'title': 'Part C: SD-809', 'description': 'EU participants who completed Part B and were willing to continue in the study continued treatment with SD-809 for 52 weeks at the current dose administered during the 12-week open-label period of Part B.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 5, 'seriousNumAtRisk': 80, 'deathsNumAffected': 2, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 32, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 28, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 56, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 23, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 34, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 29, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 31, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 41, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 51, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 45, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 25, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastric ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pancreatic duct stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hepatic cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cholecystitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Colonic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Mycobacterium avium complex infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Burns second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Carbon monoxide poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Traumatic haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Anal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Benign breast neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Squamous cell carcinoma of the tongue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Generalised non-convulsive epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Depressive symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Homicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypomania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Schizoaffective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Stress urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Iliac artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Schizophrenia, paranoid type', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 337, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part A, B, and C: Number of Participants With Treatment-Emergent AEs (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SD-809', 'description': 'Participants received SD-809 orally BID starting at 12 mg/day, which was titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who declined to participate in Part B, continued at their stable dose of SD-809 BID up to Week 158.'}, {'id': 'OG001', 'title': 'Part C: SD-809', 'description': 'EU participants who completed Part B and were willing to continue in the study continued treatment with SD-809 for 52 weeks at the current dose administered during the 12-week open-label period of Part B.'}], 'classes': [{'title': 'Any TEAEs', 'categories': [{'measurements': [{'value': '269', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Severe TEAEs', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Drug-Related TEAEs', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'TEAEs Leading to Withdrawal From Study', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to the end of follow-up (4 weeks after the last dose of study drug; mean exposure: up to approximately 866.1 days)', 'description': 'AEs were analyzed as one group combined for parts A and B per planned analysis. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE=prevents normal daily activities. Drug-related TEAEs: TEAEs with possible, probable, or definite relationship to study drug. Serious AEs: death, a life-threatening AE, 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 participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A treatment-emergent AE was defined as an AE that began after the first administration of study medication or existing AEs that worsened after the first dose of study medication. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who were administered any study drug.'}, {'type': 'PRIMARY', 'title': 'Part B: Change From Day 1 Visit in Total Motor AIMS Score at Day 7 Visit, as Assessed by Blinded Central Video Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Placebo', 'description': 'Participants received placebo matched to SD-809 for 1 week in randomized withdrawal period and thereafter received SD-809 (stable dose) for 12 weeks.'}, {'id': 'OG001', 'title': 'Part B: SD-809', 'description': 'Participants received SD-809 (stable dose) for 1 week in randomized withdrawal period and continued to receive the same dose of SD-809 for an additional 12 weeks.'}], 'classes': [{'title': 'Pre-withdrawal', 'categories': [{'measurements': [{'value': '5.7', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '0.49', 'groupId': 'OG001'}]}]}, {'title': 'Change at Post-withdrawal', 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.121', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.42', 'ciUpperLimit': '0.17', 'pValueComment': 'Threshold for significance at 0.05 level.', 'groupDescription': 'The statistical model was an analysis of covariance (ANCOVA) with treatment group and dopamine receptor antagonist status at the pre-withdrawal visit as fixed effects and the pre-withdrawal visit value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of Part B, Day 7 of Part B', '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. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The randomized withdrawal modified intent-to-treat (mITT) population included all participants enrolled in Part B who received study drug during the randomized withdrawal period and had a total motor AIMS score as assessed by blinded central video rating at both the pre-withdrawal visit and the post-withdrawal visit.'}, {'type': 'SECONDARY', 'title': 'Part A: Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: SD-809', 'description': 'Participants received SD-809 orally BID starting at 12 mg/day, which was titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who declined to participate in Part B, continued at their stable dose of SD-809 BID up to Week 158.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.6', 'spread': '0.37', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 145', 'description': 'The AIMS is an assessment tool used to detect and follow the severity of tardive dyskinesia (TD) over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Change From Baseline in Total Motor AIMS Score at Week 158, as Assessed by the Site Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: SD-809', 'description': 'Participants received SD-809 orally BID starting at 12 mg/day, which was titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who declined to participate in Part B, continued at their stable dose of SD-809 BID up to Week 158.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.3', 'spread': '0.85', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 158', '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. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Percent Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: SD-809', 'description': 'Participants received SD-809 orally BID starting at 12 mg/day, which was titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who declined to participate in Part B, continued at their stable dose of SD-809 BID up to Week 158.'}], 'classes': [{'categories': [{'measurements': [{'value': '-57.0', 'spread': '2.43', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 145', '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. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Percent Change From Baseline in Total Motor AIMS Score at Week 158, as Assessed by the Site Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: SD-809', 'description': 'Participants received SD-809 orally BID starting at 12 mg/day, which was titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who declined to participate in Part B, continued at their stable dose of SD-809 BID up to Week 158.'}], 'classes': [{'categories': [{'measurements': [{'value': '-54.9', 'spread': '6.76', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 158', '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. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Percentage of Participants Who Had a 50% or Greater Reduction From Baseline in Total Motor AIMS Score, as Assessed by the Site Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: SD-809', 'description': 'Participants received SD-809 orally BID starting at 12 mg/day, which was titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who declined to participate in Part B, continued at their stable dose of SD-809 BID up to Week 158.'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 145', '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. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Percentage of Participants Who Had a 70% or Greater Reduction From Baseline in Total Motor AIMS Score, as Assessed by the Site Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: SD-809', 'description': 'Participants received SD-809 orally BID starting at 12 mg/day, which was titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who declined to participate in Part B, continued at their stable dose of SD-809 BID up to Week 158.'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 145', '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. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Change From Baseline in AIMS Items 8, 9, and 10 Score at Week 145, as Assessed by the Site Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: SD-809', 'description': 'Participants received SD-809 orally BID starting at 12 mg/day, which was titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who declined to participate in Part B, continued at their stable dose of SD-809 BID up to Week 158.'}], 'classes': [{'title': 'Severity of abnormal movements', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.07', 'groupId': 'OG000'}]}]}, {'title': 'Incapacitation due to abnormal movements', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.08', 'groupId': 'OG000'}]}]}, {'title': "Participant's awareness of abnormal movements", 'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.09', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 145', '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. Items 8 to 10 deal with global severity as judged by the examiner, and the participant's awareness of the movements and the distress associated with them. Item 8 (used as an overall severity index indicating severity of abnormal movements) was rated on a 5-point anchored scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Items 9 and 10 (provide additional information with regard to participant's incapacitation due to abnormal movements and participant's awareness of abnormal movements) were rated on a 5-point anchored scale ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Higher scores indicated more severe disease.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Percentage of Participants Who Were a Treatment Success, Based on the Clinical Global Impression of Change (CGIC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: SD-809', 'description': 'Participants received SD-809 orally BID starting at 12 mg/day, which was titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who declined to participate in Part B, continued at their stable dose of SD-809 BID up to Week 158.'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 145', 'description': "A treatment success was defined as much or very much improved on the CGIC from baseline of this study. The CGIC is a single-item questionnaire that asks the investigator to assess a participant's TD symptoms at specific visits/weeks after initiating therapy. The CGIC uses a 7-point Likert scale, ranging from -3 to +3 (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = not changed, 1 = minimally improved, 2 = much improved, 3 = very much improved), to assess overall response to therapy.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Percentage of Participants Who Were a Treatment Success, Based on the Patient Global Impression of Change (PGIC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: SD-809', 'description': 'Participants received SD-809 orally BID starting at 12 mg/day, which was titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who declined to participate in Part B, continued at their stable dose of SD-809 BID up to Week 158.'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 145', 'description': 'A treatment success was defined as much or very much improved on the PGIC from baseline of this study. The PGIC is single-item questionnaire that asks the participant to assess their TD symptoms at specific visits/weeks after initiating therapy. The PGIC uses a 7-point Likert scale, ranging from -3 to +3 (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = not changed, 1 = minimally improved, 2 = much improved, 3 = very much improved), to assess overall response to therapy.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part A: Change From Baseline in Modified CDQ-24 Score at Week 158', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: SD-809', 'description': 'Participants received SD-809 orally BID starting at 12 mg/day, which was titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who declined to participate in Part B, continued at their stable dose of SD-809 BID up to Week 158.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.3', 'spread': '2.61', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 158', 'description': 'The CDQ-24 is a disease-specific quality of life questionnaire developed for use in participants 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. The following domains were 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 participants on a scale of 0 = never or no impairment to 4 = always or very severe impairment. Total score ranged from 0 - 96, with higher score indicative of severe impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SD-809', 'description': 'Participants received SD-809 orally BID starting at 12 mg/day, which was titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who declined to participate in Part B, continued at their stable dose of SD-809 BID up to Week 158.'}, {'id': 'FG001', 'title': 'Part B: Placebo', 'description': 'Participants received placebo matched to SD-809 for 1 week in randomized withdrawal period and thereafter received SD-809 (stable dose) for 12 weeks.'}, {'id': 'FG002', 'title': 'Part B: SD-809', 'description': 'Participants received SD-809 (stable dose) for 1 week in randomized withdrawal period and continued to receive the same dose of SD-809 for an additional 12 weeks.'}, {'id': 'FG003', 'title': 'Part C: SD-809', 'description': 'EU participants who completed Part B and were willing to continue in the study continued treatment with SD-809 for 52 weeks at the current dose administered during the 12-week open-label period of Part B.'}], 'periods': [{'title': 'Part A: Open-Label (158 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '337'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '337'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Intent-to-Treat (ITT) Population', 'comment': 'All participants who enrolled in the study, regardless of whether or not received study drug.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '337'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Participants Who Participated in Part A But Not in Part B', 'achievements': [{'groupId': 'FG000', 'numSubjects': '195'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Participants Who Agreed to Continue in Part B', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'Participants who are noted as "Completed" for Part A: completed the study in Part A (Week 158) plus continued in Part B.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '305'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Noncompliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Study terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Agreed to continue in Part B', 'reasons': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Part B: Randomized (13 Weeks)', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized withdrawal ITT population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Participants of Part A who agreed to participate in Part B', 'groupId': 'FG001', 'numSubjects': '71'}, {'comment': 'Participants of Part A who agreed to participate in Part B', 'groupId': 'FG002', 'numSubjects': '71'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Randomized Withdrawal mITT Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '65'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '68'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Part C: Safety Assessment (52 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '73'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '343 participants who completed previous SD-809 studies, including study SD-809-C-18 (NCT02195700) or SD-809-C-23 (NCT02291861) were enrolled and 337 participants were eligible for analysis. 6 participants were not evaluable and were excluded from the analysis due to site data integrity issues as reported to the United States Food and Drug Administration (US FDA).', 'preAssignmentDetails': 'Study included 3 parts: A, B, and C. Participants in Part A who were on a stable dose for ≥4 weeks after a 6-week titration, were invited to participate in Part B. Participants who are noted as "Completed" for Part A: completed the study in Part A plus continued in Part B. EU participants who completed Part B were invited to participate in Part C.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '337', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SD-809', 'description': 'Participants received SD-809 orally BID starting at 12 mg/day, which was titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who declined to participate in Part B, continued at their stable dose of SD-809 BID up to Week 158.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.9', 'spread': '10.65', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '188', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '149', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '300', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'American Indian or Alaskan Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Black', 'measurements': [{'value': '69', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '264', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Total Motor Abnormal Involuntary Movement Scale (AIMS) Score', 'classes': [{'categories': [{'measurements': [{'value': '10.7', 'spread': '4.68', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'AIMS Individual Items (8-10) Scores', 'classes': [{'title': 'Severity of abnormal movements', 'categories': [{'measurements': [{'value': '2.6', 'spread': '0.78', 'groupId': 'BG000'}]}]}, {'title': 'Incapacitation due to abnormal movements', 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.07', 'groupId': 'BG000'}]}]}, {'title': "Participant's awareness of abnormal movements", 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.08', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "AIMS is composed of 12 clinician-administered and -scored items. Item 8 (used as an overall severity index indicating severity of abnormal movements) was rated on a 5-point anchored scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Items 9 and 10 (provide additional information with regard to participant's incapacitation due to abnormal movements and participant's awareness of abnormal movements) were rated on a 5-point anchored scale ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Higher scores indicated more severe disease.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Modified Craniocervical Dystonia Questionnaire 24 (CDQ-24) Score', 'classes': [{'categories': [{'measurements': [{'value': '29.2', 'spread': '18.96', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'CDQ-24 is a disease-specific quality of life questionnaire developed for use in participants with craniocervical dystonia. CDQ-24 was modified such that the questions focus more directly on the impact of TD on quality of life. The following domains were evaluated in mCDQ-24: stigma, emotional well-being, pain, activities of daily living, and social/family life. Each of the 24 questions were rated by participants on a scale of 0 = never or no impairment to 4 = always or very severe impairment. Total score ranged from 0 - 96, with higher score indicative of severe impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'ITT population included all participants who were enrolled in the study, regardless of whether or not a participant received a dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-02', 'size': 1794080, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-11-30T07:49', 'hasProtocol': True}, {'date': '2019-12-03', 'size': 1437430, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-11-30T07:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 343}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-31', 'studyFirstSubmitDate': '2014-07-22', 'resultsFirstSubmitDate': '2020-11-30', 'studyFirstSubmitQcDate': '2014-07-22', 'lastUpdatePostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-09', 'studyFirstPostDateStruct': {'date': '2014-07-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A, B, and C: Number of Participants With Treatment-Emergent AEs (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal', 'timeFrame': 'Baseline up to the end of follow-up (4 weeks after the last dose of study drug; mean exposure: up to approximately 866.1 days)', 'description': 'AEs were analyzed as one group combined for parts A and B per planned analysis. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE=prevents normal daily activities. Drug-related TEAEs: TEAEs with possible, probable, or definite relationship to study drug. Serious AEs: death, a life-threatening AE, 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 participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A treatment-emergent AE was defined as an AE that began after the first administration of study medication or existing AEs that worsened after the first dose of study medication. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.'}, {'measure': 'Part B: Change From Day 1 Visit in Total Motor AIMS Score at Day 7 Visit, as Assessed by Blinded Central Video Rating', 'timeFrame': 'Day 1 of Part B, Day 7 of Part B', '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. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.'}], 'secondaryOutcomes': [{'measure': 'Part A: Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating', 'timeFrame': 'Baseline, Week 145', 'description': 'The AIMS is an assessment tool used to detect and follow the severity of tardive dyskinesia (TD) over time. The AIMS is composed of 12 clinician-administered and -scored items. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.'}, {'measure': 'Part A: Change From Baseline in Total Motor AIMS Score at Week 158, as Assessed by the Site Rating', 'timeFrame': 'Baseline, Week 158', '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. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.'}, {'measure': 'Part A: Percent Change From Baseline in Total Motor AIMS Score at Week 145, as Assessed by the Site Rating', 'timeFrame': 'Baseline, Week 145', '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. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.'}, {'measure': 'Part A: Percent Change From Baseline in Total Motor AIMS Score at Week 158, as Assessed by the Site Rating', 'timeFrame': 'Baseline, Week 158', '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. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.'}, {'measure': 'Part A: Percentage of Participants Who Had a 50% or Greater Reduction From Baseline in Total Motor AIMS Score, as Assessed by the Site Rating', 'timeFrame': 'Baseline to Week 145', '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. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.'}, {'measure': 'Part A: Percentage of Participants Who Had a 70% or Greater Reduction From Baseline in Total Motor AIMS Score, as Assessed by the Site Rating', 'timeFrame': 'Baseline to Week 145', '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. A total motor score from Items 1 to 7 (orofacial, extremity, and truncal movements) was calculated. Items 1 through 7 included facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). Each item was rated on a 5-point anchored scale ranging from 0 (no dyskinesia) to 4 (severe dyskinesia). Total motor AIMS score for Items 1-7 ranged from 0 to 28, with higher scores indicative of more severe dyskinesia.'}, {'measure': 'Part A: Change From Baseline in AIMS Items 8, 9, and 10 Score at Week 145, as Assessed by the Site Rating', 'timeFrame': 'Baseline, Week 145', '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. Items 8 to 10 deal with global severity as judged by the examiner, and the participant's awareness of the movements and the distress associated with them. Item 8 (used as an overall severity index indicating severity of abnormal movements) was rated on a 5-point anchored scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Items 9 and 10 (provide additional information with regard to participant's incapacitation due to abnormal movements and participant's awareness of abnormal movements) were rated on a 5-point anchored scale ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Higher scores indicated more severe disease."}, {'measure': 'Part A: Percentage of Participants Who Were a Treatment Success, Based on the Clinical Global Impression of Change (CGIC)', 'timeFrame': 'Baseline up to Week 145', 'description': "A treatment success was defined as much or very much improved on the CGIC from baseline of this study. The CGIC is a single-item questionnaire that asks the investigator to assess a participant's TD symptoms at specific visits/weeks after initiating therapy. The CGIC uses a 7-point Likert scale, ranging from -3 to +3 (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = not changed, 1 = minimally improved, 2 = much improved, 3 = very much improved), to assess overall response to therapy."}, {'measure': 'Part A: Percentage of Participants Who Were a Treatment Success, Based on the Patient Global Impression of Change (PGIC)', 'timeFrame': 'Baseline up to Week 145', 'description': 'A treatment success was defined as much or very much improved on the PGIC from baseline of this study. The PGIC is single-item questionnaire that asks the participant to assess their TD symptoms at specific visits/weeks after initiating therapy. The PGIC uses a 7-point Likert scale, ranging from -3 to +3 (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = not changed, 1 = minimally improved, 2 = much improved, 3 = very much improved), to assess overall response to therapy.'}, {'measure': 'Part A: Change From Baseline in Modified CDQ-24 Score at Week 158', 'timeFrame': 'Baseline, Week 158', 'description': 'The CDQ-24 is a disease-specific quality of life questionnaire developed for use in participants 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. The following domains were 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 participants on a scale of 0 = never or no impairment to 4 = always or very severe impairment. Total score ranged from 0 - 96, with higher score indicative of severe impairment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dyskinesias', 'Movement Disorders', 'Central Nervous System Diseases', 'Nervous System Diseases', 'Neurologic Manifestations', 'Signs and Symptoms'], 'conditions': ['Tardive Dyskinesia']}, 'referencesModule': {'references': [{'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.'}, {'pmid': '31296586', 'type': 'DERIVED', 'citation': 'Fernandez HH, Stamler D, Davis MD, Factor SA, Hauser RA, Jimenez-Shahed J, Ondo WG, Jarskog LF, Woods SW, Bega D, LeDoux MS, Shprecher DR, Anderson KE. Long-term safety and efficacy of deutetrabenazine for the treatment of tardive dyskinesia. J Neurol Neurosurg Psychiatry. 2019 Dec;90(12):1317-1323. doi: 10.1136/jnnp-2018-319918. Epub 2019 Jul 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of SD-809 in reducing the severity of abnormal involuntary movements of moderate to severe tardive dyskinesia. The purpose of part B is to establish the durability of effect of SD-809 following 1-week period of randomized withdrawal (SD-809 and placebo), followed by 12 weeks of maintenance with SD-809.', 'detailedDescription': 'Participants who complete study SD-809-C-18 (NCT02195700), SD-809-C-23 (NCT02291861), or any other SD-809 study will be enrolled in this study. This study include a screening period (Part A), a titration period (Part A), a long-term treatment period (Part A), a double-blind, randomized withdrawal period (Part B), treatment after completion of the randomized withdrawal period (Part B), and a post-treatment safety follow-up period (Part A and Part B). EU participants who complete Part B will be invited to participate in Part C.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], '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* Participant has successfully completed a controlled study of SD-809 for treatment of moderate to severe tardive dyskinesia\n* Participants 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 participants must not be pregnant and agree to an acceptable method of contraception\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 (other than Study C-18, Study C-23, or any other eligible TEV-50717 parent study) and received study drug 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': 'NCT02198794', 'acronym': 'RIM-TD', 'briefTitle': 'Reducing Involuntary Movements in Participants With Tardive Dyskinesia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'An Open-Label, Long-Term Safety Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia', 'orgStudyIdInfo': {'id': 'SD-809-C-20'}, 'secondaryIdInfos': [{'id': '2014-001891-73', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: SD-809', 'description': 'Participants will receive SD-809 orally twice daily (BID) starting at 12 mg/day, which will be titrated based on dyskinesia control and tolerability up to a maximum total dose of 48 mg/day. Participants who decline to participate in Part B, will continue at their stable dose of SD-809 BID up to Week 158.', 'interventionNames': ['Drug: SD-809']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B: Placebo', 'description': 'Participants will receive placebo matched to SD-809 for 1 week in randomized withdrawal period and thereafter will receive SD-809 (stable dose) for 12 weeks.', 'interventionNames': ['Drug: SD-809', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part B: SD-809', 'description': 'Participants will receive SD-809 (stable dose) for 1 week in randomized withdrawal period and will continue to receive the same dose of SD-809 for an additional 12 weeks.', 'interventionNames': ['Drug: SD-809']}, {'type': 'EXPERIMENTAL', 'label': 'Part C: SD-809', 'description': 'EU participants who complete Part B and willing to continue in the study will continue treatment with SD-809 for 52 weeks at the dose administered during the 12-week open-label period of Part B.', 'interventionNames': ['Drug: SD-809']}], 'interventions': [{'name': 'SD-809', 'type': 'DRUG', 'otherNames': ['Deutetrabenazine; TEV-50717'], 'description': 'SD-809 will be administered per dose and schedule specified in the arm.', 'armGroupLabels': ['Part A: SD-809', 'Part B: Placebo', 'Part B: SD-809', 'Part C: SD-809']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo matching to SD-809 will be administered per schedule specified in the arm.', 'armGroupLabels': ['Part B: 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': '92614', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 160', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 176', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 121', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095-1769', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 147', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90650', 'city': 'Norwalk', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 174', 'geoPoint': {'lat': 33.90224, 'lon': -118.08173}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 130', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 102', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92408', 'city': 'San Bernardino', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 104', 'geoPoint': {'lat': 34.10834, 'lon': -117.28977}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 110', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94901', 'city': 'San Rafael', 'state': 'California', 'country': 'United 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': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32025', 'city': 'Lake City', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 150', 'geoPoint': {'lat': 30.18968, 'lon': -82.63929}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 153', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33165', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 162', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 112', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33980', 'city': 'Port Charlotte', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 144', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', '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': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Teva Investigational Site 154', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21061', 'city': 'Glen Burnie', 'state': 'Maryland', 'country': 'United States', 'facility': 'Teva Investigational Site 101', 'geoPoint': {'lat': 39.16261, 'lon': -76.62469}}, {'zip': '63141', 'city': 'Creve Coeur', 'state': 'Missouri', 'country': 'United States', 'facility': 'Teva Investigational Site 118', 'geoPoint': {'lat': 38.66089, 'lon': -90.42262}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Teva Investigational Site 142', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63104', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Teva Investigational Site 175', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63109', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Teva Investigational Site 161', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68526-9467', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Teva Investigational Site 178', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Teva Investigational Site 128', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '27610', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 146', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '44125', 'city': 'Garfield Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Teva Investigational Site 114', 'geoPoint': {'lat': 41.417, 'lon': -81.60596}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 133', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '38163', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Teva Investigational Site 149', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 151', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '84105', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Teva Investigational Site 115', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Teva Investigational Site 141', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '99352', 'city': 'Richland', 'state': 'Washington', 'country': 'United States', 'facility': 'Teva Investigational Site 167', 'geoPoint': {'lat': 46.28569, 'lon': -119.28446}}, {'zip': '53188', 'city': 'Waukesha', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Teva Investigational Site 166', 'geoPoint': {'lat': 43.01168, 'lon': -88.23148}}, {'zip': '736 01', 'city': 'Havířov', 'country': 'Czechia', 'facility': 'Teva Investigational Site 559', 'geoPoint': {'lat': 49.77984, 'lon': 18.43688}}, {'zip': '999999', 'city': 'Hostivice', 'country': 'Czechia', 'facility': 'Teva Investigational Site 556', 'geoPoint': {'lat': 50.08158, 'lon': 14.25856}}, {'zip': '412 01', 'city': 'Litoměřice', 'country': 'Czechia', 'facility': 'Teva Investigational Site 535', 'geoPoint': {'lat': 50.53348, 'lon': 14.1318}}, {'zip': '312 00', 'city': 'Pilsen', 'country': 'Czechia', 'facility': 'Teva Investigational Site 557', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'zip': '100 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Teva Investigational Site 533', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '16000', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Teva Investigational Site 530', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '07551', 'city': 'Gera', 'country': 'Germany', 'facility': 'Teva Investigational Site 502', 'geoPoint': {'lat': 50.88029, 'lon': 12.08187}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Teva Investigational Site 504', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '999999', 'city': 'Balassagyarmat', 'country': 'Hungary', 'facility': 'Teva Investigational Site 540', 'geoPoint': {'lat': 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