Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2026-01-26 @ 11:09 AM
Study NCT ID:
NCT02348606
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2015-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000623308', 'term': 'solriamfetol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@JazzPharma.com', 'phone': '2158709177', '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': 'Through Week 14', 'eventGroups': [{'id': 'EG000', 'title': '37.5 mg of JZP-110', 'description': '37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 17, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': '75 mg of JZP-110', 'description': '75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 21, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '150 mg of JZP-110', 'description': 'Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the treatment phase, and received 150 mg JZP-110 starting on Day 4, administered orally, QD.', 'otherNumAtRisk': 117, 'deathsNumAtRisk': 117, 'otherNumAffected': 41, 'seriousNumAtRisk': 117, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': '300 mg of JZP-110', 'description': 'Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD.', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 60, 'seriousNumAtRisk': 118, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Placebo', 'description': 'Placebo administered orally, QD, for the 12 week treatment phase.', 'otherNumAtRisk': 119, 'deathsNumAtRisk': 119, 'otherNumAffected': 30, 'seriousNumAtRisk': 110, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Feeling jittery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 119, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'seriousEvents': [{'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Bile duct obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Streptococcal endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '37.5 mg of JZP-110', 'description': '37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.'}, {'id': 'OG001', 'title': '75 mg of JZP-110', 'description': '75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.'}, {'id': 'OG002', 'title': '150 mg of JZP-110', 'description': 'Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the treatment phase, and received 150 mg JZP-110 starting on Day 4, administered orally, QD.'}, {'id': 'OG003', 'title': '300 mg of JZP-110', 'description': 'Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally, QD, for the 12 week treatment phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.74', 'spread': '1.418', 'groupId': 'OG000'}, {'value': '9.08', 'spread': '1.358', 'groupId': 'OG001'}, {'value': '10.96', 'spread': '0.973', 'groupId': 'OG002'}, {'value': '12.99', 'spread': '1.038', 'groupId': 'OG003'}, {'value': '0.21', 'spread': '0.997', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to Week 12.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Fifteen subjects in the Safety Population were excluded from the Modified Intent-to Treat (mITT) Population resulting in a total of 459 subjects.'}, {'type': 'PRIMARY', 'title': 'Change in ESS Score From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '37.5 mg of JZP-110', 'description': '37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.'}, {'id': 'OG001', 'title': '75 mg of JZP-110', 'description': '75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.'}, {'id': 'OG002', 'title': '150 mg of JZP-110', 'description': 'Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the treatment phase, and received 150 mg JZP-110 starting on Day 4, administered orally, QD.'}, {'id': 'OG003', 'title': '300 mg of JZP-110', 'description': 'Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally, QD, for the 12 week treatment phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.1', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '-5.0', 'spread': '0.62', 'groupId': 'OG001'}, {'value': '-7.7', 'spread': '0.44', 'groupId': 'OG002'}, {'value': '-7.9', 'spread': '0.46', 'groupId': 'OG003'}, {'value': '-3.3', 'spread': '0.45', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 12. 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. The response variable was the change in ESS score from baseline.', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.'}, {'type': 'SECONDARY', 'title': 'Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '37.5 mg of JZP-110', 'description': '37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.'}, {'id': 'OG001', 'title': '75 mg of JZP-110', 'description': '75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.'}, {'id': 'OG002', 'title': '150 mg of JZP-110', 'description': 'Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the treatment phase, and received 150 mg JZP-110 starting on Day 4, administered orally, QD.'}, {'id': 'OG003', 'title': '300 mg of JZP-110', 'description': 'Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally, QD, for the 12 week treatment phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.4', 'groupId': 'OG000'}, {'value': '72.4', 'groupId': 'OG001'}, {'value': '89.7', 'groupId': 'OG002'}, {'value': '88.7', 'groupId': 'OG003'}, {'value': '49.1', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 Weeks', 'description': 'Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 12. PGIc was rated by subjects and measures the change in their condition since start of treatment on a 7-point scale ranging from 1 = very much improved to 7 = very much worse.\n\nThis is the key secondary endpoint.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.'}, {'type': 'SECONDARY', 'title': 'Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '37.5 mg of JZP-110', 'description': '37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.'}, {'id': 'OG001', 'title': '75 mg of JZP-110', 'description': '75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.'}, {'id': 'OG002', 'title': '150 mg of JZP-110', 'description': 'Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the treatment phase, and received 150 mg JZP-110 starting on Day 4, administered orally, QD.'}, {'id': 'OG003', 'title': '300 mg of JZP-110', 'description': 'Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally, QD, for the 12 week treatment phase.'}], 'classes': [{'title': 'Trial 1', 'categories': [{'measurements': [{'value': '3.03', 'spread': '1.881', 'groupId': 'OG000'}, {'value': '5.77', 'spread': '1.808', 'groupId': 'OG001'}, {'value': '10.87', 'spread': '1.284', 'groupId': 'OG002'}, {'value': '12.48', 'spread': '1.401', 'groupId': 'OG003'}, {'value': '-0.40', 'spread': '1.327', 'groupId': 'OG004'}]}]}, {'title': 'Trial 2', 'categories': [{'measurements': [{'value': '6.93', 'spread': '1.928', 'groupId': 'OG000'}, {'value': '9.47', 'spread': '1.849', 'groupId': 'OG001'}, {'value': '11.91', 'spread': '1.332', 'groupId': 'OG002'}, {'value': '14.94', 'spread': '1.425', 'groupId': 'OG003'}, {'value': '-0.44', 'spread': '1.380', 'groupId': 'OG004'}]}]}, {'title': 'Trial 3', 'categories': [{'measurements': [{'value': '3.59', 'spread': '1.837', 'groupId': 'OG000'}, {'value': '11.32', 'spread': '1.751', 'groupId': 'OG001'}, {'value': '11.50', 'spread': '1.261', 'groupId': 'OG002'}, {'value': '10.90', 'spread': '1.340', 'groupId': 'OG003'}, {'value': '0.58', 'spread': '1.294', 'groupId': 'OG004'}]}]}, {'title': 'Trial 4', 'categories': [{'measurements': [{'value': '6.11', 'spread': '1.845', 'groupId': 'OG000'}, {'value': '9.04', 'spread': '1.794', 'groupId': 'OG001'}, {'value': '8.93', 'spread': '1.272', 'groupId': 'OG002'}, {'value': '11.94', 'spread': '1.359', 'groupId': 'OG003'}, {'value': '1.29', 'spread': '1.305', 'groupId': 'OG004'}]}]}, {'title': 'Trial 5', 'categories': [{'measurements': [{'value': '3.57', 'spread': '1.952', 'groupId': 'OG000'}, {'value': '7.75', 'spread': '1.839', 'groupId': 'OG001'}, {'value': '8.05', 'spread': '1.347', 'groupId': 'OG002'}, {'value': '7.59', 'spread': '1.432', 'groupId': 'OG003'}, {'value': '0.18', 'spread': '1.361', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at week 12.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.'}, {'type': 'SECONDARY', 'title': 'Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-minute MWT From Baseline to Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '37.5 mg of JZP-110', 'description': '37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.'}, {'id': 'OG001', 'title': '75 mg of JZP-110', 'description': '75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.'}, {'id': 'OG002', 'title': '150 mg of JZP-110', 'description': 'Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the treatment phase, and received 150 mg JZP-110 starting on Day 4, administered orally, QD.'}, {'id': 'OG003', 'title': '300 mg of JZP-110', 'description': 'Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally, QD, for the 12 week treatment phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.53', 'spread': '1.360', 'groupId': 'OG000'}, {'value': '7.20', 'spread': '1.307', 'groupId': 'OG001'}, {'value': '11.69', 'spread': '0.932', 'groupId': 'OG002'}, {'value': '13.77', 'spread': '0.976', 'groupId': 'OG003'}, {'value': '1.24', 'spread': '0.942', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 4', 'description': 'Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to week 4.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.'}, {'type': 'SECONDARY', 'title': 'Change in ESS Score From Baseline to Week 1, Week 4, and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '37.5 mg of JZP-110', 'description': '37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.'}, {'id': 'OG001', 'title': '75 mg of JZP-110', 'description': '75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.'}, {'id': 'OG002', 'title': '150 mg of JZP-110', 'description': 'Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the treatment phase, and received 150 mg JZP-110 starting on Day 4, administered orally, QD.'}, {'id': 'OG003', 'title': '300 mg of JZP-110', 'description': 'Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally, QD, for the 12 week treatment phase.'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '-4.5', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '-4.4', 'spread': '0.65', 'groupId': 'OG001'}, {'value': '-5.5', 'spread': '0.46', 'groupId': 'OG002'}, {'value': '-6.6', 'spread': '0.46', 'groupId': 'OG003'}, {'value': '-2.6', 'spread': '0.47', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-4.7', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '-4.8', 'spread': '0.63', 'groupId': 'OG001'}, {'value': '-6.1', 'spread': '0.45', 'groupId': 'OG002'}, {'value': '-6.6', 'spread': '0.46', 'groupId': 'OG003'}, {'value': '-2.9', 'spread': '0.45', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-4.7', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '-6.3', 'spread': '0.67', 'groupId': 'OG001'}, {'value': '-6.9', 'spread': '0.48', 'groupId': 'OG002'}, {'value': '-7.7', 'spread': '0.50', 'groupId': 'OG003'}, {'value': '-3.8', 'spread': '0.49', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Weeks 1, 4, and 8', 'description': 'Change in Epworth Sleepiness Scale (ESS) score from Baseline to Weeks 1, 4, and 8. 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. The response variable was the change in ESS score from baseline.', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '37.5 mg of JZP-110', 'description': '37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.'}, {'id': 'OG001', 'title': '75 mg of JZP-110', 'description': '75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.'}, {'id': 'OG002', 'title': '150 mg of JZP-110', 'description': 'Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the treatment phase, and received 150 mg JZP-110 starting on Day 4, administered orally, QD.'}, {'id': 'OG003', 'title': '300 mg of JZP-110', 'description': 'Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally, QD, for the 12 week treatment phase.'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '58.9', 'groupId': 'OG000'}, {'value': '65.5', 'groupId': 'OG001'}, {'value': '78.3', 'groupId': 'OG002'}, {'value': '82.5', 'groupId': 'OG003'}, {'value': '47.4', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '60.7', 'groupId': 'OG000'}, {'value': '77.6', 'groupId': 'OG001'}, {'value': '84.5', 'groupId': 'OG002'}, {'value': '84.3', 'groupId': 'OG003'}, {'value': '53.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '79.3', 'groupId': 'OG001'}, {'value': '88.8', 'groupId': 'OG002'}, {'value': '87.8', 'groupId': 'OG003'}, {'value': '57.0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 1, 4, and 8', 'description': 'Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 1, Week 4, and Week 8. PGIc was rated by subjects and measures the change in their condition since treatment start on a 7-point scale ranging from 1 = very much improved to 7 = very much worse.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Reported as Improved on the Clinical Global Impression of Change (CGIc) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '37.5 mg of JZP-110', 'description': '37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.'}, {'id': 'OG001', 'title': '75 mg of JZP-110', 'description': '75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.'}, {'id': 'OG002', 'title': '150 mg of JZP-110', 'description': 'Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the treatment phase, and received 150 mg JZP-110 starting on Day 4, administered orally, QD.'}, {'id': 'OG003', 'title': '300 mg of JZP-110', 'description': 'Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally, QD, for the 12 week treatment phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.9', 'groupId': 'OG000'}, {'value': '70.7', 'groupId': 'OG001'}, {'value': '90.5', 'groupId': 'OG002'}, {'value': '88.7', 'groupId': 'OG003'}, {'value': '49.1', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "Percentage of subjects reported as improved (minimally, much, or very much) on the CGIc at Week 12. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '37.5 mg of JZP-110', 'description': '37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.'}, {'id': 'OG001', 'title': '75 mg of JZP-110', 'description': '75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.'}, {'id': 'OG002', 'title': '150 mg of JZP-110', 'description': 'Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the treatment phase, and received 150 mg JZP-110 starting on Day 4, administered orally, QD.'}, {'id': 'OG003', 'title': '300 mg of JZP-110', 'description': 'Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD.'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo administered orally, QD, for the 12 week treatment phase.'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000'}, {'value': '60.3', 'groupId': 'OG001'}, {'value': '75.7', 'groupId': 'OG002'}, {'value': '82.6', 'groupId': 'OG003'}, {'value': '46.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '60.7', 'groupId': 'OG000'}, {'value': '77.6', 'groupId': 'OG001'}, {'value': '85.2', 'groupId': 'OG002'}, {'value': '81.7', 'groupId': 'OG003'}, {'value': '52.6', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '55.4', 'groupId': 'OG000'}, {'value': '74.1', 'groupId': 'OG001'}, {'value': '87.8', 'groupId': 'OG002'}, {'value': '87.8', 'groupId': 'OG003'}, {'value': '49.1', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 1, 4, and 8', 'description': "Percentage of subjects reported as improved (minimally, much, or very much) on the CGIc at Week 1, Week 4, and Week 8. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse.", 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '37.5 mg of JZP-110', 'description': '37.5 mg JZP-110 administered orally, once daily (QD), for the 12-week treatment phase.'}, {'id': 'FG001', 'title': '75 mg of JZP-110', 'description': '75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.'}, {'id': 'FG002', 'title': '150 mg of JZP-110', 'description': 'Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the treatment phase, and received 150 mg JZP-110 starting on Day 4, administered orally, QD.'}, {'id': 'FG003', 'title': '300 mg of JZP-110', 'description': 'Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD.'}, {'id': 'FG004', 'title': 'Placebo', 'description': 'Placebo administered orally, QD, for the 12 week treatment phase.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '62'}, {'groupId': 'FG002', 'numSubjects': '117'}, {'groupId': 'FG003', 'numSubjects': '118'}, {'groupId': 'FG004', 'numSubjects': '119'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '106'}, {'groupId': 'FG003', 'numSubjects': '94'}, {'groupId': 'FG004', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'groupId': 'FG004', 'numSubjects': '18'}]}]}], 'recruitmentDetails': 'Note: 476 subjects were enrolled and randomized, however 2 subjects never received drug. This resulted in 474 subjects comprising the safety population.', 'preAssignmentDetails': 'During screening, subjects completed a medical exam. An overnight Polysomnography (PSG) assessment followed by MWT and 24-hour ABPM were conducted at baseline. After successful completion of the screening and baseline visits subjects were randomized in a 1:1:2:2:2 ratio to receive 37.5, 75, 150, or 300 mg JZP- 110 or placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}, {'value': '119', 'groupId': 'BG004'}, {'value': '474', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': '37.5 mg of JZP-110', 'description': '37.5 mg JZP-110 administered orally, QD, for the 12-week treatment phase.'}, {'id': 'BG001', 'title': '75 mg of JZP-110', 'description': '75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.'}, {'id': 'BG002', 'title': '150 mg of JZP-110', 'description': 'Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the treatment phase, and received 150 mg JZP-110 starting on Day 4, administered orally, QD.'}, {'id': 'BG003', 'title': '300 mg of JZP-110', 'description': 'Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the treatment phase and received 300 mg JZP-110 starting on Day 4, administered orally, QD.'}, {'id': 'BG004', 'title': 'Placebo', 'description': 'Placebo administered orally, QD, for the 12 week treatment phase.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.1', 'spread': '10.19', 'groupId': 'BG000'}, {'value': '54.4', 'spread': '11.46', 'groupId': 'BG001'}, {'value': '52.7', 'spread': '10.57', 'groupId': 'BG002'}, {'value': '53.2', 'spread': '10.62', 'groupId': 'BG003'}, {'value': '54.1', 'spread': '11.41', 'groupId': 'BG004'}, {'value': '53.9', 'spread': '10.75', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}, {'value': '177', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}, {'value': '77', 'groupId': 'BG004'}, {'value': '297', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '89', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}, {'value': '87', 'groupId': 'BG004'}, {'value': '361', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-08', 'size': 1953820, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-04-19T12:35', 'hasProtocol': True}, {'date': '2017-01-25', 'size': 1318169, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-04-19T12:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 476}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'dispFirstSubmitDate': '2017-11-16', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-21', 'studyFirstSubmitDate': '2015-01-15', 'dispFirstSubmitQcDate': '2017-11-16', 'resultsFirstSubmitDate': '2019-04-19', 'studyFirstSubmitQcDate': '2015-01-22', 'dispFirstPostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-21', 'studyFirstPostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12', 'timeFrame': 'Baseline to Week 12', 'description': 'Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to Week 12.'}, {'measure': 'Change in ESS Score From Baseline to Week 12', 'timeFrame': 'Baseline to Week 12', 'description': 'Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 12. 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. The response variable was the change in ESS score from baseline.'}], 'secondaryOutcomes': [{'measure': 'Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12', 'timeFrame': '12 Weeks', 'description': 'Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 12. PGIc was rated by subjects and measures the change in their condition since start of treatment on a 7-point scale ranging from 1 = very much improved to 7 = very much worse.\n\nThis is the key secondary endpoint.'}, {'measure': 'Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at week 12.'}, {'measure': 'Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-minute MWT From Baseline to Week 4', 'timeFrame': 'Baseline to Week 4', 'description': 'Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to week 4.'}, {'measure': 'Change in ESS Score From Baseline to Week 1, Week 4, and Week 8', 'timeFrame': 'Baseline to Weeks 1, 4, and 8', 'description': 'Change in Epworth Sleepiness Scale (ESS) score from Baseline to Weeks 1, 4, and 8. 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. The response variable was the change in ESS score from baseline.'}, {'measure': 'Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8', 'timeFrame': 'Weeks 1, 4, and 8', 'description': 'Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 1, Week 4, and Week 8. PGIc was rated by subjects and measures the change in their condition since treatment start on a 7-point scale ranging from 1 = very much improved to 7 = very much worse.'}, {'measure': 'Percentage of Subjects Reported as Improved on the Clinical Global Impression of Change (CGIc) at Week 12', 'timeFrame': 'Week 12', 'description': "Percentage of subjects reported as improved (minimally, much, or very much) on the CGIc at Week 12. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse."}, {'measure': 'Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8', 'timeFrame': 'Weeks 1, 4, and 8', 'description': "Percentage of subjects reported as improved (minimally, much, or very much) on the CGIc at Week 1, Week 4, and Week 8. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '34283019', 'type': 'DERIVED', 'citation': 'Rosenberg R, Thorpy MJ, Dauvilliers Y, Schweitzer PK, Zammit G, Gotfried M, Bujanover S, Scheckner B, Malhotra A. Incidence and duration of common early-onset adverse events in randomized controlled trials of solriamfetol for treatment of excessive daytime sleepiness in obstructive sleep apnea and narcolepsy. J Clin Sleep Med. 2022 Jan 1;18(1):235-244. doi: 10.5664/jcsm.9550.'}, {'pmid': '33631141', 'type': 'DERIVED', 'citation': 'Schweitzer PK, Mayer G, Rosenberg R, Malhotra A, Zammit GK, Gotfried M, Chandler P, Baladi M, Strohl KP. Randomized Controlled Trial of Solriamfetol for Excessive Daytime Sleepiness in OSA: An Analysis of Subgroups Adherent or Nonadherent to OSA Treatment. Chest. 2021 Jul;160(1):307-318. doi: 10.1016/j.chest.2021.02.033. Epub 2021 Feb 22.'}, {'pmid': '33394323', 'type': 'DERIVED', 'citation': 'Weaver TE, Menno DM, Bron M, Crosby RD, Morris S, Mathias SD. Determination of thresholds for minimally important difference and clinically important response on the functional outcomes of sleep questionnaire short version in adults with narcolepsy or obstructive sleep apnea. Sleep Breath. 2021 Sep;25(3):1707-1715. doi: 10.1007/s11325-020-02270-3. Epub 2021 Jan 4.'}, {'pmid': '33226332', 'type': 'DERIVED', 'citation': 'Rosenberg R, Baladi M, Bron M. Clinically relevant effects of solriamfetol on excessive daytime sleepiness: a posthoc analysis of the magnitude of change in clinical trials in adults with narcolepsy or obstructive sleep apnea. J Clin Sleep Med. 2021 Apr 1;17(4):711-717. doi: 10.5664/jcsm.9006.'}, {'pmid': '32353246', 'type': 'DERIVED', 'citation': 'Weaver TE, Drake CL, Benes H, Stern T, Maynard J, Thein SG, Andry JM Sr, Hudson JD, Chen D, Carter LP, Bron M, Lee L, Black J, Bogan RK. Effects of Solriamfetol on Quality-of-Life Measures from a 12-Week Phase 3 Randomized Controlled Trial. Ann Am Thorac Soc. 2020 Aug;17(8):998-1007. doi: 10.1513/AnnalsATS.202002-136OC.'}, {'pmid': '30521757', 'type': 'DERIVED', 'citation': 'Schweitzer PK, Rosenberg R, Zammit GK, Gotfried M, Chen D, Carter LP, Wang H, Lu Y, Black J, Malhotra A, Strohl KP; TONES 3 Study Investigators. Solriamfetol for Excessive Sleepiness in Obstructive Sleep Apnea (TONES 3). A Randomized Controlled Trial. Am J Respir Crit Care Med. 2019 Jun 1;199(11):1421-1431. doi: 10.1164/rccm.201806-1100OC.'}]}, 'descriptionModule': {'briefSummary': 'This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm parallel group study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Major Inclusion Criteria:\n\n1. Male or female between 18 and 75 years of age, inclusive\n2. Diagnosis of OSA according to ICSD-3 criteria\n3. Body mass index from 18 to \\<45 kg/m2\n4. Consent to use a medically acceptable method of contraception\n5. Willing and able to provide written informed consent\n\nMajor Exclusion Criteria:\n\n1. Female subjects who are pregnant, nursing, or lactating\n2. 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Received an investigational drug in the past 30 days or five half-lives\n9. Previous exposure to or participation in a clinical trial of JZP-110 (ADX-N05, R228060, or YKP10A)\n10. 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