Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-03-13 @ 5:34 PM
Study NCT ID:
NCT00620659
Status:
TERMINATED
Last Update Posted:
2015-05-13
First Post:
2008-01-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treatment of Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) Using Nasal Continuous Positive Airway Pressure (nCPAP) Therapy (0249-015)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Patients reported adverse experiences starting from the Screening Visit up until 14 days after the last dose of study drug.', 'description': 'Patients reported AEs at each visit, and the occurrence of serious adverse experiences was assessed during a telephone contact fourteen days after the last dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.', 'otherNumAtRisk': 117, 'otherNumAffected': 41, 'seriousNumAtRisk': 117, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'MK0249 5 mg', 'description': 'MK0249 was provided as 1 mg and 5 mg tablets.', 'otherNumAtRisk': 10, 'otherNumAffected': 6, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'MK0249 8 mg', 'description': 'MK0249 was provided as 1 mg and 5 mg tablets.', 'otherNumAtRisk': 25, 'otherNumAffected': 7, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'MK0249 10 mg', 'description': 'MK0249 was provided as 1 mg and 5 mg tablets.', 'otherNumAtRisk': 46, 'otherNumAffected': 16, 'seriousNumAtRisk': 46, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'MK0249 12 mg', 'description': 'MK0249 was provided as 1 mg and 5 mg tablets.', 'otherNumAtRisk': 39, 'otherNumAffected': 25, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Modafinil', 'description': 'Modafinil was provided as 100 mg tablets.', 'otherNumAtRisk': 111, 'otherNumAffected': 38, 'seriousNumAtRisk': 111, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Ear buzzing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Scleral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Subconjunctival ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Burping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gastric pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Malodorous burping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Stomach ache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Stomach fullness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Upset stomach', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Application site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chest pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chest tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Foot oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hand swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hangover', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Implant site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Increased thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG004', 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25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dry cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nasal sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nasal sinus discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nasal stuffiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Clamminess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cold sweat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diaphoresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hives', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Ingrown toe nail', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Localised erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 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0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Feeling of hot flushes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Generalised flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Acute pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Lymph node abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Essential thrombocythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 111, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean of Average Maintenance of Wakefulness Test Early for The Mode Dose of MK0249 Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'There were 116 participants who received placebo over 3 periods (42, 38, and 36 participants for Periods 1, 2, and 3 respectively).'}, {'id': 'OG001', 'title': 'MK0249 Mode Dose', 'description': 'The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg.\n\nThere were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively).'}], 'classes': [{'categories': [{'measurements': [{'value': '12.79', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '13.34', 'spread': '1.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.615', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The mixed model included terms for period and treatment.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At Week 2', 'description': 'The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the mode dose of MK0249 versus placebo.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.'}, {'type': 'SECONDARY', 'title': 'Mean of Average Maintenance of Wakefulness Test Early for the Mode Dose of MK0249 Versus Modafinil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0249 Mode Dose', 'description': 'The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg\n\nThere were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively).'}, {'id': 'OG001', 'title': 'Modafinil 200 mg', 'description': 'There were 106 participants who received Modafinil 200 mg over 3 periods (40, 36, and 30 participants for Periods 1, 2, and 3 respectively).'}], 'classes': [{'categories': [{'measurements': [{'value': '13.34', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '17.45', 'spread': '0.74', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-4.11', 'ciLowerLimit': '-5.92', 'ciUpperLimit': '-2.30', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The non-inferiority margin was 1.5 minutes. If the lower bound of the one-sided 95% confidence interval for MK0249 minus modafinil 200 mg was greater than -1.5 minutes, non-inferiority would be established.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At Week 2', 'description': 'The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the mode dose of MK0249 versus modafinil.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.'}, {'type': 'SECONDARY', 'title': 'Mean of Average Maintenance of Wakefulness Test Early for Top 2 Doses Pooled of MK0249 Versus Modafinil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK0249 Top 2 Doses Pooled', 'description': 'The top 2 doses (the two doses to which most patients were adaptively assigned) were 10 mg and 12 mg.\n\nThere were 74 participants who received MK0249 10 and 12 mg over 3 periods (25, 22, and 27 participants for Periods 1, 2, and 3 respectively).'}, {'id': 'OG001', 'title': 'Modafinil 200 mg', 'description': 'There were 106 participants who received Modafinil 200 mg over 3 periods (40, 36, and 30 participants for Periods 1, 2, and 3 respectively).'}], 'classes': [{'categories': [{'measurements': [{'value': '13.64', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '17.45', 'spread': '0.74', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-3.80', 'ciLowerLimit': '-5.23', 'ciUpperLimit': '-2.38', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The non-inferiority margin was 1.5 minutes. If the lower bound of the one-sided 95% confidence interval for MK0249 minus modafinil 200 mg was greater than -1.5 minutes, non-inferiority would be established.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At Week 2', 'description': 'The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the top 2 doses pooled of MK0249 versus modafinil.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impressions Scale of Severity Score as it Relates to Excessive Daytime Sleepiness (CGIS-EDS) for the Mode Dose of MK0249 Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'There were 116 participants who received placebo over 3 periods (42, 38, and 36 participants for Periods 1, 2, and 3 respectively).'}, {'id': 'OG001', 'title': 'MK0249 Mode Dose', 'description': 'The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg.\n\nThere were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.76', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '3.43', 'spread': '0.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.079', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The mixed model included terms for period and treatment.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At Week 2', 'description': 'Clinical Global Impressions Scale of Severity (CGI-S) is a subscale of the CGI which is a standard psychometric scale used to demonstrate changes and improvements in illness. CGI-S consists of a 7-point scale rated from 1 to 7. The investigator or sponsor-approved clinician judged how ill the patient was with respect to Excessive Daytime Sleepiness (EDS) at the time of the CGI-S rating (CGIS-EDS), with higher scores indicating more severe illness.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.'}, {'type': 'SECONDARY', 'title': 'Epworth Sleepiness Scale (ESS) Score for the Mode Dose of MK0249 Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'There were 116 participants who received placebo over 3 periods (42, 38, and 36 participants for Periods 1, 2, and 3 respectively).'}, {'id': 'OG001', 'title': 'MK0249 Mode Dose', 'description': 'The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg.\n\nThere were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively).'}], 'classes': [{'categories': [{'measurements': [{'value': '12.81', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '10.83', 'spread': '0.65', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The mixed model included terms for period and treatment.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At Week 2', 'description': 'The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire that provides subjective reports that equate with sleep propensity, not with \'subjective sleepiness\'. Having a high sleep propensity means having a history of dozing in situations that have a relatively low soporific nature, in which normal subjects seldom doze. The ESS consists of eight items, which are rated from 0 ("would never dose") to 3 ("high chance of dozing"). The ESS score is the total score of the 8 individual items; this total score ranges from 0 to 24 (higher total score is worse).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS population was a subset of all randomized patients with patients excluded for failure to receive at least one dose of study treatment or lack of an endpoint data. Patients with at least one dose and endpoint in at least one treatment period were included in the FAS.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MK0249/Placebo/Modafinil', 'description': 'Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.\n\nMK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.'}, {'id': 'FG001', 'title': 'Placebo/Modafinil/MK0249', 'description': 'Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.\n\nMK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.'}, {'id': 'FG002', 'title': 'Modafinil/MK0249/Placebo', 'description': 'Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.\n\nMK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.'}, {'id': 'FG003', 'title': 'MK0249/Modafinil/Placebo', 'description': 'Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.\n\nMK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.'}, {'id': 'FG004', 'title': 'Placebo/MK0249/Modafinil', 'description': 'Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.\n\nMK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.'}, {'id': 'FG005', 'title': 'Modafinil/Placebo/MK0249', 'description': 'Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.\n\nMK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.'}], 'periods': [{'title': 'Treatment Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '21'}, {'groupId': 'FG004', 'numSubjects': '21'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'comment': '1 patient discontinued from MK0249, but continued in following periods, \\& completed the study', 'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Placebo Washout Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Placebo Washout Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "The majority of patients were recruited from investigators' own databases at 24 sites in the United States. The primary therapy period was 13-Mar-2008 to 25-Feb-2009.", 'preAssignmentDetails': 'Participants maintained sleep and sleepiness diaries during a 7- to 10-day placebo run-in period. They used a nasal continuous positive airway pressure (nCPAP) device to monitor their CPAP use. At the end of the run-in period, participants stayed overnight at the clinic for nighttime polysomnography and if eligible, were randomized the next morning'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Randomized Participants', 'description': 'All participants randomized in study'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.6', 'spread': '8.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '100', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-27', 'studyFirstSubmitDate': '2008-01-10', 'resultsFirstSubmitDate': '2010-10-13', 'studyFirstSubmitQcDate': '2008-02-11', 'lastUpdatePostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-01-27', 'studyFirstPostDateStruct': {'date': '2008-02-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean of Average Maintenance of Wakefulness Test Early for The Mode Dose of MK0249 Versus Placebo', 'timeFrame': 'At Week 2', 'description': 'The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the mode dose of MK0249 versus placebo.'}], 'secondaryOutcomes': [{'measure': 'Mean of Average Maintenance of Wakefulness Test Early for the Mode Dose of MK0249 Versus Modafinil', 'timeFrame': 'At Week 2', 'description': 'The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the mode dose of MK0249 versus modafinil.'}, {'measure': 'Mean of Average Maintenance of Wakefulness Test Early for Top 2 Doses Pooled of MK0249 Versus Modafinil', 'timeFrame': 'At Week 2', 'description': 'The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a patient to remain awake. The primary endpoint was the mean of sleep latency (average of the first 4 MWTs which were at 0900, 1100, 1300, and 1500), where latency for each MWT was defined as the time to onset of the first 16 continuous seconds of any stage of sleep; if no sleep was observed according to these rules, then latency was defined as 30 minutes. The comparison was for the top 2 doses pooled of MK0249 versus modafinil.'}, {'measure': 'Clinical Global Impressions Scale of Severity Score as it Relates to Excessive Daytime Sleepiness (CGIS-EDS) for the Mode Dose of MK0249 Versus Placebo', 'timeFrame': 'At Week 2', 'description': 'Clinical Global Impressions Scale of Severity (CGI-S) is a subscale of the CGI which is a standard psychometric scale used to demonstrate changes and improvements in illness. CGI-S consists of a 7-point scale rated from 1 to 7. The investigator or sponsor-approved clinician judged how ill the patient was with respect to Excessive Daytime Sleepiness (EDS) at the time of the CGI-S rating (CGIS-EDS), with higher scores indicating more severe illness.'}, {'measure': 'Epworth Sleepiness Scale (ESS) Score for the Mode Dose of MK0249 Versus Placebo', 'timeFrame': 'At Week 2', 'description': 'The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire that provides subjective reports that equate with sleep propensity, not with \'subjective sleepiness\'. Having a high sleep propensity means having a history of dozing in situations that have a relatively low soporific nature, in which normal subjects seldom doze. The ESS consists of eight items, which are rated from 0 ("would never dose") to 3 ("high chance of dozing"). The ESS score is the total score of the 8 individual items; this total score ranges from 0 to 24 (higher total score is worse).'}]}, 'conditionsModule': {'conditions': ['Sleep Apnea, Obstructive', 'Hypopnea Syndrome', 'Excessive Daytime Sleepiness']}, 'referencesModule': {'references': [{'pmid': '23920422', 'type': 'RESULT', 'citation': 'Herring WJ, Liu K, Hutzelmann J, Snavely D, Snyder E, Ceesay P, Lines C, Michelson D, Roth T. Alertness and psychomotor performance effects of the histamine-3 inverse agonist MK-0249 in obstructive sleep apnea patients on continuous positive airway pressure therapy with excessive daytime sleepiness: a randomized adaptive crossover study. Sleep Med. 2013 Oct;14(10):955-63. doi: 10.1016/j.sleep.2013.04.010. Epub 2013 Aug 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and efficacy of MK0249 in treating refractory excessive daytime sleepiness (EDS) in patients with Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) using nasal continuous positive airway pressure (nCPAP) therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is male or female and is at least 18 years old and less than 65 years old\n* Patient must have a diagnosis of Obstructive Sleep Apnea/Hypopnea Syndrome\n* Patient has been using nCPAP treatment for at least 2 months prior to Visit 1\n* Patient is willing to stay at a sleep laboratory for 4 full days and nights for observation and assessments\n* Patient is willing to refrain from napping for the duration of the study\n\nExclusion Criteria:\n\n* Patient is pregnant, breastfeeding, or planning to become pregnant within the next 4 months\n* Patient is or has participated in a study with an investigational compound or device within 30 days of signing the informed consent\n* Patient has had asthma-related visit to the emergency room or hospitalization within 6 months of Visit 1\n* Patient has donated or received blood products within 8 weeks of signing consent or is planning on doing either for the duration of the study'}, 'identificationModule': {'nctId': 'NCT00620659', 'briefTitle': 'Treatment of Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) Using Nasal Continuous Positive Airway Pressure (nCPAP) Therapy (0249-015)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Phase IIa, Randomized, Double-blind, Placebo-controlled, 3-period Crossover, Adaptive Dose Design, Clinical Trial to Evaluate Safety & Efficacy of MK0249 in Treating Refractory Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome Appropriately Using nCPAP Therapy.', 'orgStudyIdInfo': {'id': '0249-015'}, 'secondaryIdInfos': [{'id': '2007_602'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Arm 1: Treatment period 1: MK0249; Treatment period 2: Placebo; Treatment period 3: modafinil', 'interventionNames': ['Drug: Comparator: MK0249', 'Drug: Comparator: placebo', 'Drug: Comparator: modafinil']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Arm 2: Treatment period 1: Placebo; Treatment period 2: modafinil; Treatment period 3: MK0249', 'interventionNames': ['Drug: Comparator: MK0249', 'Drug: Comparator: placebo', 'Drug: Comparator: modafinil']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Arm 3: Treatment period 1: modafinil; Treatment period 2: MK0249; Treatment period 3: Placebo', 'interventionNames': ['Drug: Comparator: MK0249', 'Drug: Comparator: placebo', 'Drug: Comparator: modafinil']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Arm 4: Treatment period 1: MK0249; Treatment period 2: modafinil; Treatment period 3: Placebo', 'interventionNames': ['Drug: Comparator: MK0249', 'Drug: Comparator: placebo', 'Drug: Comparator: modafinil']}, {'type': 'EXPERIMENTAL', 'label': '5', 'description': 'Arm 5: Treatment period 1: Placebo; Treatment period 2: MK0249; Treatment period 3: modafinil', 'interventionNames': ['Drug: Comparator: MK0249', 'Drug: Comparator: placebo', 'Drug: Comparator: modafinil']}, {'type': 'EXPERIMENTAL', 'label': '6', 'description': 'Arm 6: Treatment period 1: modafinil; Treatment period 2: Placebo; Treatment period 3: MK0249', 'interventionNames': ['Drug: Comparator: MK0249', 'Drug: Comparator: placebo', 'Drug: Comparator: modafinil']}], 'interventions': [{'name': 'Comparator: MK0249', 'type': 'DRUG', 'description': 'Patients will be assigned to receive MK0249 film coated tablet (FCT). The doses of MK0249 that are included for possible investigation (depending upon an adaptive allocation process) are 3 mg, 5 mg, 8 mg, 10 mg, and 12 mg. Study medication will be taken for 14 days, during each of the 3 treatment periods, by mouth (po) once a day (qd).', 'armGroupLabels': ['1', '2', '3', '4', '5', '6']}, {'name': 'Comparator: placebo', 'type': 'DRUG', 'description': 'Placebo; Patients will be assigned to receive placebo, across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd.', 'armGroupLabels': ['1', '2', '3', '4', '5', '6']}, {'name': 'Comparator: modafinil', 'type': 'DRUG', 'description': 'Patients will be assigned to receive modafinil 200mg oral compressed tablet (OCT), across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd.', 'armGroupLabels': ['1', '2', '3', '4', '5', '6']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}