Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-02-24 @ 5:46 AM
Study NCT ID:
NCT02348632
Status:
COMPLETED
Last Update Posted:
2019-06-25
First Post:
2015-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009290', 'term': 'Narcolepsy'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}, {'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'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000623308', 'term': 'solriamfetol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@JazzPharma.com', 'phone': '215-970-7145', 'title': 'Director, Disclosure & Transparency', 'organization': 'Jazz Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'The sponsor can review trial results communications prior to public release and can embargo such communications for a period of at least 60 days from the time submitted to sponsor for review. If requested by sponsor, the PI will withhold publication for up to an additional 30 days. Furthermore, the first publication of study results must be a joint publication of all study sites unless a joint manuscript has not been submitted for publication within 12 months of completion of the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The Safety Population consisted of all subjects who received at least 1 dose of study medication. Adverse events are reported across the entire study (e.g., the open-label and randomized withdrawal periods combined).', 'eventGroups': [{'id': 'EG000', 'title': 'JZP-110', 'description': 'Subjects completed a 2-week Titration phase. They then entered the maintenance phase of up to 50 weeks at the stable dose that was reached at the end of the Titration Phase.', 'otherNumAtRisk': 643, 'deathsNumAtRisk': 643, 'otherNumAffected': 269, 'seriousNumAtRisk': 643, 'deathsNumAffected': 1, 'seriousNumAffected': 27}, {'id': 'EG001', 'title': 'Placebo', 'description': 'JZP-110 administered orally, QD, for the 2-week randomized withdrawal period, at the same dose subjects were currently receiving.', 'otherNumAtRisk': 142, 'deathsNumAtRisk': 142, 'otherNumAffected': 3, 'seriousNumAtRisk': 142, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'seriousEvents': [{'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Prostate cancer stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Stillbirth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Bipolar I disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hallucination, auditory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Prostatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Anaemia postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Ear canal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Skull fractured base', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Procedural hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cluster headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Retinal vein occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Gastrointestinal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 643, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 142, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Epworth Sleepiness Scale (ESS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'JZP-110', 'description': 'Subjects completed a 2-week Titration phase. They then entered the maintenance phase of up to 50 weeks at the stable dose that was reached at the end of the Titration Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'JZP-110 administered orally, QD, for the 2-week randomized withdrawal period, at the same dose subjects were currently receiving.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '0.41', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Start of randomized withdrawal phase to end of randomized withdrawal (2 weeks)', 'description': 'Change in Epworth Sleepiness Scale (ESS) score during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. A negative change from baseline represents improvement in excessive sleepiness.\n\nThe ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. This analysis included treatment group and randomization stratification factor (narcolepsy vs. OSA) as fixed effects. The ESS score at the beginning of the randomized withdrawal period was used as the covariate. The response variable was the change in ESS score from the beginning to the end of 2- week randomized withdrawal period.', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': '282 subjects were randomized into the randomized withdrawal period. Two subjects who were treated in the randomized withdrawal period did not have evaluable efficacy data during that period. Therefore, the mITT Population comprised 280 subjects, 141 who received placebo and 139 who received JZP-110.'}, {'type': 'SECONDARY', 'title': 'Subjects Reported as Worse on the Patient Global Impression of Change (PGIc)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'JZP-110', 'description': 'Subjects completed a 2-week Titration phase. They then entered the maintenance phase of up to 50 weeks at the stable dose that was reached at the end of the Titration Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'JZP-110 administered orally, QD, for the 2-week randomized withdrawal period, at the same dose subjects were currently receiving.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.2', 'groupId': 'OG000'}, {'value': '64.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)', 'description': 'Percentage of subjects reported as worse (minimally worse, much worse, or very much worse) on the PGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': '282 subjects were randomized into the randomized withdrawal period. Two subjects who were treated in the randomized withdrawal period did not have evaluable efficacy data during that period. Therefore, the mITT Population comprised 280 subjects, 141 who received placebo and 139 who received JZP-110.'}, {'type': 'SECONDARY', 'title': 'Subjects Reported as Worse on the Clinical Global Impression of Change (CGIc)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'JZP-110', 'description': 'Subjects completed a 2-week Titration phase. They then entered the maintenance phase of up to 50 weeks at the stable dose that was reached at the end of the Titration Phase.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'JZP-110 administered orally, QD, for the 2-week randomized withdrawal period, at the same dose subjects were currently receiving.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.7', 'groupId': 'OG000'}, {'value': '63.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)', 'description': 'Subjects reported as worse (very much worse, much worse, and minimally worse) on the CGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': '282 subjects were randomized into the randomized withdrawal period. Two subjects who were treated in the randomized withdrawal period did not have evaluable efficacy data during that period. Therefore, the mITT Population comprised 280 subjects, 141 who received placebo and 139 who received JZP-110.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'JZP-110', 'description': 'Subjects completed a 2-week Titration phase. They then entered the maintenance phase of up to 50 weeks at the stable dose that was reached at the end of the Titration Phase.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo administered orally, QD, for the 2-week randomized withdrawal period.'}], 'periods': [{'title': 'Open-label Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '643'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '458'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '185'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Randomized Withdrawal Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}, {'groupId': 'FG001', 'numSubjects': '142'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '141'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 645 subjects were enrolled in the study; 2 subjects withdrew from the study prior to receiving study drug. A total of 643 subjects received at least 1 dose of JZP-110 in the open-label phase and were included in the Safety Population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Open-label Period', 'description': '643 subjects comprised the safety population.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.31', 'spread': '14.155', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '306', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '337', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '109', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '506', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-11-17', 'size': 2195665, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-04-19T12:14', 'hasProtocol': True}, {'date': '2016-11-17', 'size': 681382, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-04-19T12:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 645}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'dispFirstSubmitDate': '2018-12-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-04', 'studyFirstSubmitDate': '2015-01-15', 'dispFirstSubmitQcDate': '2018-12-05', 'resultsFirstSubmitDate': '2019-04-19', 'studyFirstSubmitQcDate': '2015-01-22', 'dispFirstPostDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-04', 'studyFirstPostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Epworth Sleepiness Scale (ESS) Score', 'timeFrame': 'Start of randomized withdrawal phase to end of randomized withdrawal (2 weeks)', 'description': 'Change in Epworth Sleepiness Scale (ESS) score during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. A negative change from baseline represents improvement in excessive sleepiness.\n\nThe ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. This analysis included treatment group and randomization stratification factor (narcolepsy vs. OSA) as fixed effects. The ESS score at the beginning of the randomized withdrawal period was used as the covariate. The response variable was the change in ESS score from the beginning to the end of 2- week randomized withdrawal period.'}], 'secondaryOutcomes': [{'measure': 'Subjects Reported as Worse on the Patient Global Impression of Change (PGIc)', 'timeFrame': 'Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)', 'description': 'Percentage of subjects reported as worse (minimally worse, much worse, or very much worse) on the PGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline.'}, {'measure': 'Subjects Reported as Worse on the Clinical Global Impression of Change (CGIc)', 'timeFrame': 'Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)', 'description': 'Subjects reported as worse (very much worse, much worse, and minimally worse) on the CGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Narcolepsy', 'Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '36084494', 'type': 'DERIVED', 'citation': 'Malhotra A, Strollo PJ Jr, Pepin JL, Schweitzer P, Lammers GJ, Hedner J, Redline S, Chen D, Chandler P, Bujanover S, Strohl K. Effects of solriamfetol treatment on body weight in participants with obstructive sleep apnea or narcolepsy. Sleep Med. 2022 Dec;100:165-173. doi: 10.1016/j.sleep.2022.08.005. Epub 2022 Aug 14.'}, {'pmid': '34606437', 'type': 'DERIVED', 'citation': 'Weaver TE, Pepin JL, Schwab R, Shapiro C, Hedner J, Ahmed M, Foldvary-Schaefer N, Strollo PJ, Mayer G, Sarmiento K, Baladi M, Bron M, Chandler P, Lee L, Malhotra A. Long-term effects of solriamfetol on quality of life and work productivity in participants with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. J Clin Sleep Med. 2021 Oct 1;17(10):1995-2007. doi: 10.5664/jcsm.9384.'}, {'pmid': '33179591', 'type': 'DERIVED', 'citation': 'Schweitzer PK, Strohl KP, Mayer G, Rosenberg R, Chandler P, Baladi M, Lee L, Malhotra A. Effects of solriamfetol in a long-term trial of participants with obstructive sleep apnea who are adherent or nonadherent to airway therapy. J Clin Sleep Med. 2021 Apr 1;17(4):659-668. doi: 10.5664/jcsm.8992.'}, {'pmid': '31691827', 'type': 'DERIVED', 'citation': 'Malhotra A, Shapiro C, Pepin JL, Hedner J, Ahmed M, Foldvary-Schaefer N, Strollo PJ, Mayer G, Sarmiento K, Baladi M, Chandler P, Lee L, Schwab R. Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea. Sleep. 2020 Feb 13;43(2):zsz220. doi: 10.1093/sleep/zsz220.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Major Inclusion Criteria:\n\n1. Subject meets one of the following:\n\n 1. Completed Study 14-002 or 14-003 (Group A)\n 2. Completed Study 14-004, 15-004, 15-005, ADX-N05 201 or ADX-N05 202 (Group B)\n2. Body mass index from 18 to \\<45 kg/m2\n3. Consent to use a medically acceptable method of contraception\n4. Willing and able to provide written informed consent\n\nMajor Exclusion Criteria:\n\n1. Female subjects who are pregnant, nursing, or lactating\n2. Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy or OSA that is associated with excessive sleepiness\n3. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria\n4. Presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy or safety assessments, or the ability of the subject to complete the trial per the judgment of the Investigator\n5. History of bariatric surgery within the past year or a history of roux-en-y procedure\n6. Presence or history of significant cardiovascular disease\n7. Use of any over the counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness\n8. Received an investigational drug other than JZP-110 in the past 30 days or five half-lives (whichever is longer)\n9. History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products'}, 'identificationModule': {'nctId': 'NCT02348632', 'briefTitle': '"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jazz Pharmaceuticals'}, 'officialTitle': 'A Long-Term Safety and Maintenance of Efficacy Study ofJZP-110 [(R)-2-amino-3 Phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': '14-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '75 mg - 300 mg of JZP-110', 'description': 'Once Daily Dosing', 'interventionNames': ['Drug: JZP-110']}], 'interventions': [{'name': 'JZP-110', 'type': 'DRUG', 'armGroupLabels': ['75 mg - 300 mg of JZP-110']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35213', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Sleep Disorders Center of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pulmonary Associates', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Preferred Research Partners', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Medical Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'So Cal Institute For Respiratory Diseases, Inc.', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92054', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Sleep Medicine', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'The Research Center of Southern California', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Center for Narcolepsy', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Research Network Inc.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'VA San Diego Healthcare System', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Santa Monica Clinical Trials', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Critical care Pulmonary & Sleep Associates, LLC', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '33009', 'city': 'Hallandale', 'state': 'Florida', 'country': 'United States', 'facility': 'MD Clinical', 'geoPoint': {'lat': 25.9812, 'lon': -80.14838}}, {'zip': '32765', 'city': 'Oviedo', 'state': 'Florida', 'country': 'United States', 'facility': 'Oviedo Medical Research, LLC', 'geoPoint': {'lat': 28.67, 'lon': -81.20812}}, {'zip': '33707', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Group of St. Petersburg', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Pediatric Research Institute', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Sleep Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'NeuroTrials Research Inc.', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '31201', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'SleepMed of Central Georgia', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Feinberg School of Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago Nursing School', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66214', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'Rowe Neurology Institute RNI - Lenexa', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '66606', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': 'Veritas Clinical Specialties LTD', 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '402318', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentucky Research Group', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Advanced Neurodiagnostic Center', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Center for Sleep & Wake Disorders', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '24590', 'city': 'Newton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Neurocare, Inc.', 'geoPoint': {'lat': 42.33704, 'lon': -71.20922}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital Sleep Disorders & Research Center', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48314', 'city': 'Sterling Heights', 'state': 'Michigan', 'country': 'United States', 'facility': 'Clinical Neurophysiology Services', 'geoPoint': {'lat': 42.58031, 'lon': -83.0302}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Lung Center', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Sleep Medicine & Research center, St. Lukes Hospital', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '65201', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '63143', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Clayton Sleep Institute', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Clinilabs', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '28602', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Hickory Research Center', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Hickory Research Center, ARSM Research, LLC', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Raleigh Neurology Associates', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Wilmington', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '44122', 'city': 'Beachwood', 'state': 'Ohio', 'country': 'United States', 'facility': 'Northcoast Clinical Trials Inc.', 'geoPoint': {'lat': 41.4645, 'lon': -81.50873}}, {'zip': '45245', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Sleep Management Institute', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45255', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'CTI Clinical Research Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44130', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Southwest Cleveland Sleep Research Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43017', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Sleep Medicine & Neuroscience Institute', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}, {'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mercy St. Anne & Mercy St. Charles Sleep Disorders Center', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Center for Sleep and Circadian Neurobiology', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Sleep Medicine Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29406', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Lowcountry Lung Critical Care', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29201', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Sleep Med of South Carolina Clinical Research Solutions', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'FutureSearch Trials of Neurology LP', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77063', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Todd J. Swick', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Sleep Therapy & Research Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23510', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'EVMS Sleep Medicine', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '22182', 'city': 'Vienna', 'state': 'Virginia', 'country': 'United States', 'facility': 'American Sleep Medicine', 'geoPoint': {'lat': 38.90122, 'lon': -77.26526}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L2E 7H9', 'city': 'Niagra Falls', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Niagra Clinical Research'}, {'zip': 'M4P 1P2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Sleep Institute', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'm5K 2A7', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Psychiatric Research Foundation', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M6J 3S3', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Pediatric Sleep Research Inc', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H4J 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CARSM Sleep Laboratory & Clinic', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '33200', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Unesta Research Center', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'facility': 'University of Turku , Sleep Research Centre', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '38700', 'city': 'La Tronche', 'country': 'France', 'facility': 'Grenoble University Hospital', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Hospital Roger Salengro', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '75004', 'city': 'Paris', 'country': 'France', 'facility': 'Universite Paris 5 Hôtel-Dieu', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75018', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Bichat - Claude Bernard', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '44263', 'city': 'Dortmund', 'country': 'Germany', 'facility': 'Somnolab Dortmund', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'zip': '19055', 'city': 'Schwerin', 'country': 'Germany', 'facility': 'Klinische Forschung Schwerin GmbH', 'geoPoint': {'lat': 53.62937, 'lon': 11.41316}}, {'zip': '2103 SW', 'city': 'Heemstede', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Sleep Wake Center SEIN Heemstede', 'geoPoint': {'lat': 52.34992, 'lon': 4.62301}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jazz Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}