Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-22 @ 7:04 AM
Study NCT ID:
NCT03829657
Status:
TERMINATED
Last Update Posted:
2023-01-20
First Post:
2019-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D054970', 'term': 'Pure Autonomic Failure'}, {'id': 'D007024', 'term': 'Hypotension, Orthostatic'}, {'id': 'D007022', 'term': 'Hypotension'}, {'id': 'D004244', 'term': 'Dizziness'}, {'id': 'D013575', 'term': 'Syncope'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D054971', 'term': 'Orthostatic Intolerance'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000601820', 'term': 'ampreloxetine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@theravance.com', 'phone': '855 633 8479', 'title': 'Medical Monitor', 'phoneExt': '+1', 'organization': 'Theravance Biopharma Ireland Limited'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'De Novo participants in the OL treatment period had limited follow-up due to early termination of the study.'}}, 'adverseEventsModule': {'timeFrame': 'OL Treatment Period: Day 1 to Week 16 (plus a 2 week follow-up period); RW Treatment Period: Week 16 to Week 24 (plus a 2 week follow-up period)', 'description': 'OL Safety Analysis Set: all enrolled participants who received at least 1 dose of ampreloxetine during the OL period.\n\nRW Treatment Safety Analysis Set: all randomized participants who received at least 1 dose of study medication (ampreloxetine or placebo) following randomization. The Safety Analysis Set and FAS were identical for the RW treatment period.', 'eventGroups': [{'id': 'EG000', 'title': 'OL Treatment Period: 0169 Placebo Rollover', 'description': 'Participants who received the placebo in study 0169, received 10 mg oral ampreloxetine once a day (QD) for up to 16 weeks.', 'otherNumAtRisk': 83, 'deathsNumAtRisk': 83, 'otherNumAffected': 41, 'seriousNumAtRisk': 83, 'deathsNumAffected': 2, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'OL Treatment Period: 0169 Ampreloxetine Rollover', 'description': 'Participants who received ampreloxetine in study 0169, received 10 mg oral ampreloxetine QD for up to 16 weeks.', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 48, 'seriousNumAtRisk': 85, 'deathsNumAffected': 3, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'OL Treatment Period: De Novo', 'description': 'Participants with symptomatic neurogenic orthostatic hypotension (nOH) who met all applicable study inclusion criteria and none of the applicable exclusion criteria, received 10 mg oral ampreloxetine QD for up to 16 weeks. These participants did not roll over from the 0169 study.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 16, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'RW Treatment Period: Placebo', 'description': 'Participants who completed the OL treatment period and were randomized to receive oral placebo QD for a further 6 weeks in the RW treatment period.', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 16, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'RW Treatment Period: Ampreloxetine', 'description': 'Participants who completed the OL treatment period and were randomized to receive 10 mg oral ampreloxetine QD for a further 6 weeks in the RW treatment period.', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 17, 'seriousNumAtRisk': 64, 'deathsNumAffected': 2, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'On and off phenomenon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Dizziness exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Hypokinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Multiple system atrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Oromandibular dystonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Radial nerve palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Restless legs syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Spasmodic dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Speech disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 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'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}, {'term': 'Spinal column injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 64, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '24.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Participants With Treatment Failure at Week 6 of RW Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RW Treatment Period: Placebo', 'description': 'Participants who completed the OL treatment period and were randomized to receive oral placebo QD for a further 6 weeks in the RW treatment period.'}, {'id': 'OG001', 'title': 'RW Treatment Period: Ampreloxetine', 'description': 'Participants who completed the OL treatment period and were randomized to receive 10 mg oral ampreloxetine QD for a further 6 weeks in the RW treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.42', 'spread': '0.068', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '0.065', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.196', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.27', 'ciUpperLimit': '1.29', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6-week randomized withdrawal period (Week 16 to Week 22)', 'description': "Treatment failure was defined as proportion of participants who met the following criteria at Week 6 following randomization: Change (worsening) from baseline in Question 1 of the Orthostatic Hypotension Symptom Assessment (OHSA#1) score of 1.0 point and worsening of disease severity as assessed by a 1-point change in Patient Global Impression of Severity (PGI-S). OHSA Question #1 assessed dizziness, lightheadedness, feeling faint, or feeling like you might blackout. PGI-S assessed patient's impression of disease severity.\n\nLeast squares mean here is the model-based proportion of participants with treatment failure using logistic regression.", 'unitOfMeasure': 'Proportion of participants', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'RW Treatment Period Full Analysis Set: all randomized participants who received at least 1 dose of study medication (ampreloxetine or placebo) following randomization.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OL Treatment Period: 0169 Placebo Rollover', 'description': 'Participants who received the placebo in study 0169, received 10 mg oral ampreloxetine once a day (QD) for up to 16 weeks.'}, {'id': 'FG001', 'title': 'OL Treatment Period: 0169 Ampreloxetine Rollover', 'description': 'Participants who received ampreloxetine in study 0169, received 10 mg oral ampreloxetine QD for up to 16 weeks.'}, {'id': 'FG002', 'title': 'OL Treatment Period: De Novo', 'description': 'Participants with symptomatic neurogenic orthostatic hypotension (nOH) who met all applicable study inclusion criteria and none of the applicable exclusion criteria, received 10 mg oral ampreloxetine QD for up to 16 weeks. These participants did not roll over from the 0169 study.'}, {'id': 'FG003', 'title': 'RW Treatment Period: Placebo', 'description': 'Participants who completed the OL treatment period and were randomized to receive oral placebo QD for a further 6 weeks in the RW treatment period.'}, {'id': 'FG004', 'title': 'RW Treatment Period: Ampreloxetine', 'description': 'Participants who completed the OL treatment period and were randomized to receive 10 mg oral ampreloxetine QD for a further 6 weeks in the RW treatment period.'}], 'periods': [{'title': 'OL Treatment Period (Week 1 to Week 16)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '85'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Failure to Meet Day 29 Continuation Criterion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'RW Treatment Period (Week 16 to Week 24)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '64'}, {'groupId': 'FG004', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '61'}, {'groupId': 'FG004', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled from February 2019 to November 2021. 203 participants were enrolled in the open label (OL) treatment period, including 170 participants from the 0169 study (NCT number: NCT03750552). 128 participants who completed the OL treatment period continued in the randomized withdrawal (RW) treatment period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '200', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'OL Treatment Period: 0169 Placebo Rollover', 'description': 'Participants who received the placebo in study 0169, received 10 mg oral ampreloxetine once a day (QD) for up to 16 weeks.'}, {'id': 'BG001', 'title': 'OL Treatment Period: 0169 Ampreloxetine Rollover', 'description': 'Participants who received ampreloxetine in study 0169, received 10 mg oral ampreloxetine QD for up to 16 weeks.'}, {'id': 'BG002', 'title': 'OL Treatment Period: De Novo', 'description': 'Participants with symptomatic neurogenic orthostatic hypotension (nOH) who met all applicable study inclusion criteria and none of the applicable exclusion criteria, received 10 mg oral ampreloxetine QD for up to 16 weeks. These participants did not roll over from the 0169 study.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.2', 'spread': '9.35', 'groupId': 'BG000'}, {'value': '68.2', 'spread': '9.00', 'groupId': 'BG001'}, {'value': '69.0', 'spread': '7.97', 'groupId': 'BG002'}, {'value': '68.4', 'spread': '8.96', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '140', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '185', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '194', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'OL Treatment Period Safety Analysis Set: all enrolled participants who received at least 1 dose of ampreloxetine during the OL period.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-05', 'size': 5424835, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-11-07T14:34', 'hasProtocol': True}, {'date': '2021-12-14', 'size': 1431596, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-11-07T14:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open Label Extension followed by Randomized Parallel Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 203}}, 'statusModule': {'whyStopped': 'Stopped early due to company decision. Company decision based on analysis results in TD-9855-0169.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-29', 'studyFirstSubmitDate': '2019-01-10', 'resultsFirstSubmitDate': '2022-11-08', 'studyFirstSubmitQcDate': '2019-01-31', 'lastUpdatePostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-29', 'studyFirstPostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants With Treatment Failure at Week 6 of RW Treatment Period', 'timeFrame': '6-week randomized withdrawal period (Week 16 to Week 22)', 'description': "Treatment failure was defined as proportion of participants who met the following criteria at Week 6 following randomization: Change (worsening) from baseline in Question 1 of the Orthostatic Hypotension Symptom Assessment (OHSA#1) score of 1.0 point and worsening of disease severity as assessed by a 1-point change in Patient Global Impression of Severity (PGI-S). OHSA Question #1 assessed dizziness, lightheadedness, feeling faint, or feeling like you might blackout. PGI-S assessed patient's impression of disease severity.\n\nLeast squares mean here is the model-based proportion of participants with treatment failure using logistic regression."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Symptomatic Neurogenic Orthostatic Hypotension', 'symptomatic nOH', 'multiple symptom atrophy', 'MSA', "Parkinson's disease", 'PD', 'pure autonomic failure', 'PAF', 'orthostatic hypotension', 'OH', 'REDWOOD', 'ampreloxetine', 'low blood pressure', 'dizziness', 'fainting', 'blacking out', 'lightheadedness', 'norepinephrine', 'hypotension', 'Neurogenic Orthostatic Hypotension', 'nOH', '170', '0170', '145', '0145', 'TD-9855', 'TD9855', 'Parkinsonism'], 'conditions': ['Symptomatic Neurogenic Orthostatic Hypotension', 'MSA', "Parkinson's Disease (PD)", 'Pure Autonomic Failure (PAF)']}, 'descriptionModule': {'briefSummary': 'A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of ampreloxetine in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure', 'detailedDescription': 'Phase 3, multi-center, randomized withdrawal study to evaluate the sustained benefit in efficacy and safety of ampreloxetine in subjects with primary autonomic failures (MSA, PD, or PAF) and symptomatic nOH. The study consists of 3 periods: (i) 16-week open-label (OL) treatment with ampreloxetine, (ii) 6-week randomized placebo-controlled treatment, and (iii) 2-week follow-up (only for patients who do not enroll in Study 0171 (long-term extension safety study)).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria (For 0169 Completers Group):\n\n* Subject has completed 4 weeks of double blind treatment in Study 0169 (V6) and, in the opinion of the Investigator, could benefit from continued treatment with ampreloxetine. Only subjects with OHSA#1 score of ≤7 will be eligible for randomization for the double-blind treatment period.\n* Subject has a minimum of 80% study medication compliance in Study 0169.\n\nInclusion Criteria (For De Novo Group):\n\n* Subject is male or female and at least 30 years old.\n* Subject must meet the diagnostic criteria of symptomatic nOH, as demonstrated by a sustained reduction in BP of ≥20 mm Hg (systolic) or ≥10 mm Hg (diastolic) within 3 min of being tilted-up ≥60o from a supine position as determined by a tilt-table test.\n* Subject must score at least a 4 on the OHSA#1 at V1.\n* For subjects with PD only: Subject has a diagnosis of PD according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria (1992).\n* For subjects with MSA only: Subject has a diagnosis of possible or probable MSA of the Parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C) according to The Gilman Criteria (2008).\n* For subjects with PAF only: Subject has documented impaired autonomic reflexes, including the Valsalva maneuver performed within 24 months from the date of randomization\n* Subject has plasma Norepinephrine (NE) levels ≥ 100 pg/mL after being in seated position for 30 minutes.\n\nExclusion Criteria (For 0169 Completers Group):\n\n* Subject has a medical, laboratory, or surgical issue(s) deemed by the investigator to be clinically significant.\n* Subject has an uncooperative attitude or reasonable likelihood of non-compliance with the protocol.\n* Subject has a concurrent disease or condition that, in the opinion of the investigator, would confound or interfere with study participation or evaluation of safety, tolerability, or pharmacokinetics of the study drug.\n\nExclusion Criteria (For De Novo Group):\n\n* Subject has a known systemic illness known to produce autonomic neuropathy, including but not limited to amyloidosis, and autoimmune neuropathies.\n* Subject has a known intolerance to other NRIs or serotonin norepinephrine reuptake inhibitors (SNRIs).\n* Subject currently uses concomitant antihypertensive medication for the treatment of essential hypertension unrelated to autonomic dysfunction.\n* Subject has used strong CYP1A2 inhibitors or inducers within 7 days or 5 half-lives, whichever is longer, prior to V1 or requires concomitant use until the follow-up visit.\n* Subject has changed dose, frequency, or type of prescribed medication for orthostatic hypotension within 7 days prior to V1.\n\n * Midodrine and droxidopa (if applicable) must be tapered off at least 7 days prior to V1.\n* Subject has known or suspected alcohol or substance abuse within the past 12 months (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision \\[DSM-IV-TR®\\] definition of alcohol or substance abuse).\n* Subject has a clinically unstable coronary artery disease, or has had a major cardiovascular or neurological event in the past 6 months.\n* Subject has used any monoamine oxidase inhibitor (MAO-I) within 14 days prior to V1.\n* Subject has a history of untreated closed angle glaucoma, or treated closed angle glaucoma that, in the opinion of an ophthalmologist, might result in an increased risk to the subject.\n* Subject has any significant uncontrolled cardiac arrhythmia.\n* Subject has a Montreal Cognitive Assessment (MoCA) ≤23.\n* Subject is unable or unwilling to complete all protocol specified procedures including questionnaires.\n* Subject had a myocardial infarction in the past 6 months or has current unstable angina.\n* Subject has known congestive heart failure (New York Heart Association \\[NYHA\\] Class 3 or 4).\n* Subject has a clinically significant abnormal laboratory finding (e.g., alanine aminotransferase \\[ALT\\] or aspartate aminotransferase \\[AST\\] \\>3.0 x upper limit of normal \\[ULN\\]; blood bilirubin \\[total\\] \\>1.5 x ULN; estimated glomerular filtration rate (eGFR) \\<30 mL/min/1.73 m2, or any abnormal laboratory value that could interfere with safety of the subject).\n* Subject has demonstrated a history of lifetime suicidal ideation and/or suicidal behavior, as outlined by the Columbia Suicide Severity Rating Scale (C-SSRS)(Baseline/Screening Version). Subject should be assessed by the rater for risk of suicide and the subject's appropriateness for inclusion in the study."}, 'identificationModule': {'nctId': 'NCT03829657', 'acronym': 'REDWOOD', 'briefTitle': 'Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic Failure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Theravance Biopharma'}, 'officialTitle': 'A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure', 'orgStudyIdInfo': {'id': '0170'}, 'secondaryIdInfos': [{'id': '2018-003941-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ampreloxetine (Open Label (OL))', 'description': 'Participants will receive ampreloxetine as a single, oral, daily dose of active drug for 16 weeks.', 'interventionNames': ['Drug: ampreloxetine']}, {'type': 'EXPERIMENTAL', 'label': 'ampreloxetine', 'description': 'After completing the OL, participants randomized to ampreloxetine will receive single, oral, daily dose of active drug for a further 6 weeks.', 'interventionNames': ['Drug: ampreloxetine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'After completing the OL, participants randomized to Placebo will receive single, oral, daily dose of placebo for 6 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ampreloxetine', 'type': 'DRUG', 'otherNames': ['TD-9855'], 'description': 'Oral tablet, QD (Daily)', 'armGroupLabels': ['ampreloxetine', 'ampreloxetine (Open Label (OL))']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral tablet, QD', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Sun Health Research Institute', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '92307', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Movement Disorder Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Neuroscience Health Center', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Springs Neurological Associates, PC', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': "Parkinson's Disease and Movement Disorders Center", 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33487', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'SFM Clinical Research, LLC', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33952', 'city': 'Port Charlotte', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurostudies, Inc', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60026', 'city': 'Glenview', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University Health System', 'geoPoint': {'lat': 42.06975, 'lon': -87.78784}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center Research Institute, Inc.', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Baptist Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati Medical Center (UCGNI)', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University - 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