Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT00606593
Status:
COMPLETED
Last Update Posted:
2016-03-14
First Post:
2008-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Almorexant (ACT-078573) in Elderly Subjects With Chronic Primary Insomnia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C519150', 'term': 'almorexant'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+41 61 565 65 65', 'title': 'Pascal Charef/Clinical Trial Leader', 'organization': 'Actelion Pharmaceuticals Ltd'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events and serious adverse events were collected during each treatment period. Each treatment period included up to 4 days after the last administration of study treatment.', 'description': 'Safety population', 'eventGroups': [{'id': 'EG000', 'title': 'Single-blind Placebo', 'description': 'Treatment administered during screening period', 'otherNumAtRisk': 112, 'otherNumAffected': 5, 'seriousNumAtRisk': 112, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Two capsules containing placebo, orally administered on each of 2 consecutive nights', 'otherNumAtRisk': 107, 'otherNumAffected': 12, 'seriousNumAtRisk': 107, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'ACT-078573 25 mg', 'description': 'Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights', 'otherNumAtRisk': 106, 'otherNumAffected': 12, 'seriousNumAtRisk': 106, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'ACT-078573 50 mg', 'description': 'Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights', 'otherNumAtRisk': 106, 'otherNumAffected': 10, 'seriousNumAtRisk': 106, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'ACT-078573 100 mg', 'description': 'Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights', 'otherNumAtRisk': 106, 'otherNumAffected': 11, 'seriousNumAtRisk': 106, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'ACT-078573 200 mg', 'description': 'Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights', 'otherNumAtRisk': 108, 'otherNumAffected': 10, 'seriousNumAtRisk': 108, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'SOMNOLENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'DEPRESSED LEVEL OF CONSCIOUSNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'DRY MOUTH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ELECTROCARDIOGRAM ST SEGMENT DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'EXCORIATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'SKIN IRRITATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'RASH ERYTHEMATOUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ATRIOVENTRICULAR BLOCK SECOND DEGREE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'BALANCE DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'BLOOD CREATININE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'BLOOD GLUCOSE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'BLOOD UREA INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'CONJUNCTIVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'EAR INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'EXOSTOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'EYE INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'EYE INFECTION VIRAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'GAIT DISTURBANCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'HICCUPS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'LOWER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'MUSCLE SPASMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'MUSCULAR WEAKNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'PHOTOSENSITIVITY REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'POLLAKIURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'RHINITIS SEASONAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'SEDATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'SINUS CONGESTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'URETHRAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'URINARY INCONTINENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'CONTUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'DRY SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'EYE INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'MUSCULOSKELETAL STIFFNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'SEASONAL ALLERGY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'SUPRAVENTRICULAR EXTRASYSTOLES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'seriousEvents': [{'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Wake Time After Sleep Onset (WASO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two capsules containing placebo, orally administered on each of 2 consecutive nights'}, {'id': 'OG001', 'title': 'ACT-078573 25 mg', 'description': 'Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights'}, {'id': 'OG002', 'title': 'ACT-078573 50 mg', 'description': 'Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights'}, {'id': 'OG003', 'title': 'ACT-078573 100 mg', 'description': 'Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights'}, {'id': 'OG004', 'title': 'ACT-078573 200 mg', 'description': 'Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights'}], 'classes': [{'categories': [{'measurements': [{'value': '109.1', 'spread': '36.0', 'groupId': 'OG000'}, {'value': '98.7', 'spread': '35.5', 'groupId': 'OG001'}, {'value': '90.0', 'spread': '35.7', 'groupId': 'OG002'}, {'value': '77.7', 'spread': '33.2', 'groupId': 'OG003'}, {'value': '62.6', 'spread': '27.5', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square means treatment effect', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.4', 'ciLowerLimit': '-17.0', 'ciUpperLimit': '-3.9', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square means treatment effect', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.2', 'ciLowerLimit': '-25.7', 'ciUpperLimit': '-12.6', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least square means treatment effect', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-31.4', 'ciLowerLimit': '-38.0', 'ciUpperLimit': '-24.9', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least square means treatment effect', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-46.5', 'ciLowerLimit': '-53.3', 'ciUpperLimit': '-39.9', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 treatment nights', 'description': 'WASO was the time in minutes scored as wake between the onset of persistent sleep and lights on, where the onset of persistent sleep was the beginning of the first continuous 20 epochs (10 min) scored as non-wake.\n\nMean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable due to protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the WASO was missing (e.g., persistent sleep did not occur), the missing value was substituted with the highest value recorded for the subject during the study (single-blind period included).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of evaluable patients for this parameter in the per protocol set. Only subjects with all 5 valid values are included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Mean Total Sleep Time (TST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '100', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Two capsules containing placebo, orally administered on each of 2 consecutive nights'}, {'id': 'OG001', 'title': 'ACT-078573 25 mg', 'description': 'Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights'}, {'id': 'OG002', 'title': 'ACT-078573 50 mg', 'description': 'Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights'}, {'id': 'OG003', 'title': 'ACT-078573 100 mg', 'description': 'Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights'}, {'id': 'OG004', 'title': 'ACT-078573 200 mg', 'description': 'Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights'}], 'classes': [{'categories': [{'measurements': [{'value': '339.7', 'spread': '43.2', 'groupId': 'OG000'}, {'value': '353.8', 'spread': '40.1', 'groupId': 'OG001'}, {'value': '360.9', 'spread': '41.7', 'groupId': 'OG002'}, {'value': '374.2', 'spread': '39.6', 'groupId': 'OG003'}, {'value': '394.7', 'spread': '34.6', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square means treatment effect', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.3', 'ciLowerLimit': '7.4', 'ciUpperLimit': '21.2', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least square means treatment effect', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.5', 'ciLowerLimit': '14.6', 'ciUpperLimit': '28.4', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least square means treatment effect', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.7', 'ciLowerLimit': '27.8', 'ciUpperLimit': '41.6', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Least square means treatment effect', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '55.1', 'ciLowerLimit': '48.2', 'ciUpperLimit': '62.0', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 treatment nights', 'description': 'TST was the amount of actual sleep time measured in minutes scored as non-wake (i.e., sleep stage 1, 2, slow-wave sleep, or rapid eye movement (sleep)).\n\nMean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable by protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the TST was missing (e.g., the subject did not sleep or persistent sleep did not occur), the missing value was substituted with the worst value recorded for the subject during the study (single-blind period included).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of evaluable patients for this parameter in the per protocol set. Only subjects with all 5 valid values are included in this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Sequence 200/100/P/50/25', 'description': 'Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: almorexant (ACT-078573) 200 mg/ACT-078573 100 mg/Placebo/ACT-078573 50 mg/ACT-078573 25mg.'}, {'id': 'FG001', 'title': 'Treatment Sequence 100/50/200/25/P', 'description': 'Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 100 mg/ACT-078573 50 mg/ACT-078573 200 mg/ACT-078573 25 mg/placebo.'}, {'id': 'FG002', 'title': 'Treatment Sequence 50/25/100/P/200', 'description': 'Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 50 mg/ACT-078573 25 mg/ACT-078573 100 mg/placebo/ACT-078573 200 mg.'}, {'id': 'FG003', 'title': 'Treatment Sequence 25/P/50/200/100', 'description': 'Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 25 mg/placebo/ACT-078573 50 mg/ACT-078573 200 mg/ACT-078573 100 mg.'}, {'id': 'FG004', 'title': 'Treatment Sequence P/200/25/100/50', 'description': 'Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: placebo/ACT-078573 200 mg/ACT-078573 25 mg/ACT-078573 100 mg/ACT-078573 50 mg.'}, {'id': 'FG005', 'title': 'Treatment Sequence 25/50/P/100/200', 'description': 'Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 25 mg/ACT-078573 50 mg/placebo/ACT-078573 100 mg/ACT-078573 200 mg.'}, {'id': 'FG006', 'title': 'Treatment Sequence P/25/200/50/100', 'description': 'Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: placebo/ACT-078573 25 mg/ACT-078573 200 mg/ACT-078573 50 mg/ACT-078573 100 mg.'}, {'id': 'FG007', 'title': 'Treatment Sequence 200/P/100/25/50', 'description': 'Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 200 mg/placebo/ACT-078573 100 mg/ACT-078573 25 mg/ACT-078573 50 mg.'}, {'id': 'FG008', 'title': 'Treatment Sequence 100/200/50/P/25', 'description': 'Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 100 mg/ACT-078573 200 mg/ACT-078573 50 mg/placebo/ACT-078573 25 mg.'}, {'id': 'FG009', 'title': 'Treatment Sequence 50/100/25/200/P', 'description': 'Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 50 mg/ACT-078573 100 mg/ACT-078573 25 mg/ACT-078573 200 mg/placebo.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomized participants', 'groupId': 'FG000', 'numSubjects': '11'}, {'comment': 'Randomized participants', 'groupId': 'FG001', 'numSubjects': '11'}, {'comment': 'Randomized participants', 'groupId': 'FG002', 'numSubjects': '11'}, {'comment': 'Randomized participants', 'groupId': 'FG003', 'numSubjects': '11'}, {'comment': 'Randomized participants', 'groupId': 'FG004', 'numSubjects': '12'}, {'comment': 'Randomized participants', 'groupId': 'FG005', 'numSubjects': '11'}, {'comment': 'Randomized participants', 'groupId': 'FG006', 'numSubjects': '11'}, {'comment': 'Randomized participants. One participant actually received the treatment sequence 200/P/100/ 50/25', 'groupId': 'FG007', 'numSubjects': '11'}, {'comment': 'Randomized participants', 'groupId': 'FG008', 'numSubjects': '12'}, {'comment': 'Randomized participants', 'groupId': 'FG009', 'numSubjects': '11'}]}, {'type': '1st Double-blind Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '11'}, {'groupId': 'FG007', 'numSubjects': '11'}, {'groupId': 'FG008', 'numSubjects': '12'}, {'groupId': 'FG009', 'numSubjects': '11'}]}, {'type': '2nd Double-blind Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '10'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '12'}, {'groupId': 'FG009', 'numSubjects': '11'}]}, {'type': '3rd Double-blind Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '10'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '12'}, {'groupId': 'FG009', 'numSubjects': '11'}]}, {'type': '4th Double-blind Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '10'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '11'}, {'groupId': 'FG009', 'numSubjects': '11'}]}, {'type': '5th Double-blind Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '10'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '11'}, {'groupId': 'FG009', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '11'}, {'groupId': 'FG006', 'numSubjects': '10'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '11'}, {'groupId': 'FG009', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Withdrawal of consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Administrative/Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '242 subjects were screened at 18 centers in the United States and received single-blind placebo treatment. The first subject screening visit was 12 Dec 2007, the first subject was treated on 19 Dec 2007. 112 subjects were randomized, the first assigned double-blind treatment, was on 26 Dec 2007. Last subject, last clinic visit ended on 4 Apr 2008.', 'preAssignmentDetails': 'The study consisted of a 2-4-week screening phase on single-blind placebo, a 4-8-week treatment phase, and a 28 day safety follow-up. Subjects were randomized to one of 10 treatment sequences.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patient Flow', 'description': 'The study consisted of a 2-4-week screening phase (including 2 consecutive screening polysomnography (PSG) nights on single blind placebo), a 4- to 8-week treatment phase, and a 28 day safety follow-up. The treatment phase immediately followed randomization and included 5 treatment periods, each consisting of 2 consecutive treatment PSG nights on the assigned study treatment separated by 5 to 12 days of washout. Subjects were randomized to one of 10 treatment sequences.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.0', 'spread': '4.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '78', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'dispFirstSubmitDate': '2010-02-11', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-11', 'studyFirstSubmitDate': '2008-01-04', 'dispFirstSubmitQcDate': '2010-02-11', 'resultsFirstSubmitDate': '2012-12-21', 'studyFirstSubmitQcDate': '2008-01-22', 'dispFirstPostDateStruct': {'date': '2010-02-15', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-03-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-06', 'studyFirstPostDateStruct': {'date': '2008-02-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Wake Time After Sleep Onset (WASO)', 'timeFrame': '2 treatment nights', 'description': 'WASO was the time in minutes scored as wake between the onset of persistent sleep and lights on, where the onset of persistent sleep was the beginning of the first continuous 20 epochs (10 min) scored as non-wake.\n\nMean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable due to protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the WASO was missing (e.g., persistent sleep did not occur), the missing value was substituted with the highest value recorded for the subject during the study (single-blind period included).'}], 'secondaryOutcomes': [{'measure': 'Mean Total Sleep Time (TST)', 'timeFrame': '2 treatment nights', 'description': 'TST was the amount of actual sleep time measured in minutes scored as non-wake (i.e., sleep stage 1, 2, slow-wave sleep, or rapid eye movement (sleep)).\n\nMean values were calculated based on 2 treatment PSG nights. PSG nights identified as non-evaluable by protocol violation were excluded. If a mean value could not be calculated because the value for 1 PSG night was missing or non-evaluable, the valid value for the other PSG night was used. If during a double-blind treatment period a valid PSG was performed but the TST was missing (e.g., the subject did not sleep or persistent sleep did not occur), the missing value was substituted with the worst value recorded for the subject during the study (single-blind period included).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['insomnia', 'elderly', 'sleeplessness'], 'conditions': ['Chronic Primary Insomnia']}, 'descriptionModule': {'briefSummary': 'A 2-night polysomnography / 5-way cross-over study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in elderly subjects with primary insomnia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elderly subjects (\\> 64 years) with a diagnosis of primary insomnia.\n\nExclusion Criteria:\n\n* History of any sleep disorder, or any Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) axis I disorder other than primary insomnia.\n* Sleep apnea, or restless legs syndrome.\n* Daytime napping of more than 1 hour per day.\n* Important caffeine consumption, heavy tobacco use, alcohol or drug abuse within 2 years prior to the screening visit.\n* Unwillingness to refrain from drugs, over-the-counter or herbal medication having an effect on sleep or behavior.'}, 'identificationModule': {'nctId': 'NCT00606593', 'briefTitle': 'Almorexant (ACT-078573) in Elderly Subjects With Chronic Primary Insomnia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Midnight Pharma, LLC'}, 'officialTitle': 'Multicenter, Double-blind, Randomized, Placebo-controlled, 5-period, 5-treatment Crossover, Dose-finding Study to Evaluate the Efficacy and Safety of Oral Administration of ACT-078573 in Elderly Subjects With Chronic Primary Insomnia', 'orgStudyIdInfo': {'id': 'AC-057A201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABECD', 'description': '5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo', 'interventionNames': ['Drug: ACT-078573 oral capsules at 25 and 100 mg and matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BCADE', 'description': '5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo', 'interventionNames': ['Drug: ACT-078573 and matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'CDBEA', 'description': '5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo', 'interventionNames': ['Drug: ACT-078573 and matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'DECAB', 'description': '5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo', 'interventionNames': ['Drug: ACT-078573 and matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'EADBC', 'description': '5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo', 'interventionNames': ['Drug: ACT-078573 and matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'DCEBA', 'description': '5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo', 'interventionNames': ['Drug: ACT-078573 and matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'EDACB', 'description': '5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo', 'interventionNames': ['Drug: ACT-078573 and matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'AEBDC', 'description': '5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo', 'interventionNames': ['Drug: ACT-078573 and matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BACED', 'description': '5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo', 'interventionNames': ['Drug: ACT-078573 and matching placebo']}, {'type': 'EXPERIMENTAL', 'label': 'CBDAE', 'description': '5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo', 'interventionNames': ['Drug: ACT-078573 and matching placebo']}], 'interventions': [{'name': 'ACT-078573 oral capsules at 25 and 100 mg and matching placebo', 'type': 'DRUG', 'description': '5-period, 5-treatment crossover: sequences: ABECD, BCADE, CDBEA, DECAB, EADBC DCEBA, EDACB, AEBDC, BACED, CBDAE Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo', 'armGroupLabels': ['ABECD']}, {'name': 'ACT-078573 and matching placebo', 'type': 'DRUG', 'description': 'ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo', 'armGroupLabels': ['BCADE']}, {'name': 'ACT-078573 and matching placebo', 'type': 'DRUG', 'description': 'ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment 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at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo', 'armGroupLabels': ['EDACB']}, {'name': 'ACT-078573 and matching placebo', 'type': 'DRUG', 'description': 'ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo', 'armGroupLabels': ['AEBDC']}, {'name': 'ACT-078573 and matching placebo', 'type': 'DRUG', 'description': 'ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo', 'armGroupLabels': ['CBDAE']}, {'name': 'ACT-078573 and matching placebo', 'type': 'DRUG', 'description': 'ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo', 'armGroupLabels': ['BACED']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Central Arkansas Research', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Sleep Medicine Services, Inc.', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Sleep Medicine Services, Inc.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'California Clinical Trials Medical Group, Inc.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'PAB Clinical Research', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Research Associates', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34110', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'OmniTrials', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '33026', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Broward Research Group & Sleep-Wake Disorders Center of South Florida', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Neurotrials Research, Inc.', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Sleep Disorders Center of Georgia', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Vince and Associates Clinical Research', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '41017', 'city': 'Crestview Hills', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Community Research', 'geoPoint': {'lat': 39.02728, 'lon': -84.58494}}, {'zip': '48098', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Clinical Neurophysiology Services, P.C.', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Sleep Disorders & Research Center', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '89104', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Clinical Research Center of Nevada', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45227', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Tri-State Sleep Disorders Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Health Systems', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Lynn Health Sciences Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '29201', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Sleep Disorders Center', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Sleep Medicine Associates P.A.', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'James K. Walsh, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sleep Medicine and Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Midnight Pharma, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}