Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-05-04 @ 8:02 PM
Study NCT ID:
NCT02348593
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2015-01-15
Is 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 Narcolepsy"
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009290', 'term': 'Narcolepsy'}], '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'}]}, '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': 'Through Week 14', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo administered orally, QD, for the 12 week treatment phase.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 17, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '75 mg of JZP-110', 'description': '75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 19, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '150 mg 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 then received 150 mg JZP-110 starting on Day 4, administered orally, QD.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 32, 'seriousNumAtRisk': 59, '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': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 36, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'seriousEvents': [{'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 59, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', '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': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo 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 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 then 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.12', 'spread': '1.289', 'groupId': 'OG000'}, {'value': '4.74', 'spread': '1.335', 'groupId': 'OG001'}, {'value': '9.77', 'spread': '1.327', 'groupId': 'OG002'}, {'value': '12.27', 'spread': '1.389', 'groupId': 'OG003'}]}]}], '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. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake; a positive change from baseline represents improvement in the sleep latency time. Mean sleep latency defined as the average of the first 4 MWT trials, if 3 or 4 of them are non-missing.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.'}, {'type': 'PRIMARY', 'title': 'Change in ESS Score From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo 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 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 then 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '0.67', 'groupId': 'OG001'}, {'value': '-5.4', 'spread': '0.66', 'groupId': 'OG002'}, {'value': '-6.4', 'spread': '0.68', 'groupId': 'OG003'}]}]}], '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': 'Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.'}, {'type': 'SECONDARY', 'title': 'Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo 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 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 then 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.7', 'groupId': 'OG000'}, {'value': '67.8', 'groupId': 'OG001'}, {'value': '78.2', 'groupId': 'OG002'}, {'value': '84.7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 12', '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 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': 'Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.'}, {'type': 'SECONDARY', 'title': 'Change in Sleep Latency Time on MWT Trial 1 at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo 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 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 then 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.55', 'spread': '4.658', 'groupId': 'OG000'}, {'value': '3.27', 'spread': '1.725', 'groupId': 'OG001'}, {'value': '9.87', 'spread': '1.713', 'groupId': 'OG002'}, {'value': '9.91', 'spread': '1.841', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline for sleep latency in MWT during trial 1 at 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': 'Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.'}, {'type': 'SECONDARY', 'title': 'Change in Sleep Latency Time on MWT Trial 2 at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo 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 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 then 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.41', 'spread': '1.638', 'groupId': 'OG000'}, {'value': '5.70', 'spread': '1.697', 'groupId': 'OG001'}, {'value': '9.46', 'spread': '1.674', 'groupId': 'OG002'}, {'value': '14.50', 'spread': '1.835', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline for sleep latency in MWT during trial 2 at 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': 'Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.'}, {'type': 'SECONDARY', 'title': 'Change in Sleep Latency Time on MWT Trial 3 at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo 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 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 then 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.79', 'spread': '1.799', 'groupId': 'OG000'}, {'value': '6.35', 'spread': '1.908', 'groupId': 'OG001'}, {'value': '11.31', 'spread': '1.859', 'groupId': 'OG002'}, {'value': '13.99', 'spread': '1.996', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline for sleep latency in MWT during trial 3 at 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': 'Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.'}, {'type': 'SECONDARY', 'title': 'Change in Sleep Latency Time on MWT Trial 4 at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo 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 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 then 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.33', 'spread': '1.579', 'groupId': 'OG000'}, {'value': '3.77', 'spread': '1.663', 'groupId': 'OG001'}, {'value': '9.77', 'spread': '1.606', 'groupId': 'OG002'}, {'value': '13.50', 'spread': '1.734', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline for sleep latency in MWT during trial 4 at 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': 'Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.'}, {'type': 'SECONDARY', 'title': 'Change in Sleep Latency Time on MWT Trial 5 at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo 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 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 then 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.09', 'spread': '1.808', 'groupId': 'OG000'}, {'value': '3.92', 'spread': '1.928', 'groupId': 'OG001'}, {'value': '9.25', 'spread': '1.888', 'groupId': 'OG002'}, {'value': '12.20', 'spread': '1.969', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline for sleep latency in MWT during trial 5 at 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': 'Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 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': '58', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo 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 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 then 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.16', 'spread': '1.202', 'groupId': 'OG000'}, {'value': '4.67', 'spread': '1.223', 'groupId': 'OG001'}, {'value': '9.15', 'spread': '1.246', 'groupId': 'OG002'}, {'value': '13.07', 'spread': '1.211', 'groupId': 'OG003'}]}]}], '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': 'Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '75 mg of JZP-110', 'description': '75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.'}, {'id': 'FG001', 'title': '150 mg 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 then received 150 mg JZP-110 starting on Day 4, administered orally, QD.'}, {'id': 'FG002', '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': 'FG003', 'title': 'Placebo', 'description': 'Placebo administered orally, QD, for the 12 week treatment phase.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '59'}, {'groupId': 'FG003', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '43'}, {'groupId': 'FG003', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '7'}]}]}], 'preAssignmentDetails': '239 subjects were randomized in a 1:1:1:1 ratio to receive placebo, 75 mg JZP-110, 150 mg JZP-110 or 300 mg JZP-110. 236 subjects received at least 1 dose of study medication and comprised the Safety Population; the remaining 3 subjects were randomized in error (did not receive study medication) and were excluded from the Safety Population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '236', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '75 mg of JZP-110', 'description': '75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.'}, {'id': 'BG001', 'title': '150 mg 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 then received 150 mg JZP-110 starting on Day 4, administered orally, QD.'}, {'id': 'BG002', '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': 'BG003', 'title': 'Placebo', 'description': 'Placebo administered orally, QD, for the 12 week treatment phase.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.5', 'spread': '12.78', 'groupId': 'BG000'}, {'value': '38.1', 'spread': '13.00', 'groupId': 'BG001'}, {'value': '34.3', 'spread': '11.51', 'groupId': 'BG002'}, {'value': '36.0', 'spread': '15.17', 'groupId': 'BG003'}, {'value': '36.3', 'spread': '12.47', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '154', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '82', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}, {'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'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '189', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-08', 'size': 2413539, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-04-19T12:43', 'hasProtocol': True}, {'date': '2017-03-02', 'size': 1440260, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-04-19T12:45', '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': 239}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'dispFirstSubmitDate': '2018-01-19', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-21', 'studyFirstSubmitDate': '2015-01-15', 'dispFirstSubmitQcDate': '2018-01-19', 'resultsFirstSubmitDate': '2019-04-19', 'studyFirstSubmitQcDate': '2015-01-22', 'dispFirstPostDateStruct': {'date': '2018-01-25', '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': '2017-02', '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. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake; a positive change from baseline represents improvement in the sleep latency time. Mean sleep latency defined as the average of the first 4 MWT trials, if 3 or 4 of them are non-missing.'}, {'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': 'Baseline to Week 12', '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 treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse'}, {'measure': 'Change in Sleep Latency Time on MWT Trial 1 at Week 12', 'timeFrame': 'Change from baseline for sleep latency in MWT during trial 1 at 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 Sleep Latency Time on MWT Trial 2 at Week 12', 'timeFrame': 'Change from baseline for sleep latency in MWT during trial 2 at 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 Sleep Latency Time on MWT Trial 3 at Week 12', 'timeFrame': 'Change from baseline for sleep latency in MWT during trial 3 at 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 Sleep Latency Time on MWT Trial 4 at Week 12', 'timeFrame': 'Change from baseline for sleep latency in MWT during trial 4 at 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 Sleep Latency Time on MWT Trial 5 at Week 12', 'timeFrame': 'Change from baseline for sleep latency in MWT during trial 5 at 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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Narcolepsy']}, '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': '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': '32588401', 'type': 'DERIVED', 'citation': 'Dauvilliers Y, Shapiro C, Mayer G, Lammers GJ, Emsellem H, Plazzi G, Chen D, Carter LP, Lee L, Black J, Thorpy MJ. Solriamfetol for the Treatment of Excessive Daytime Sleepiness in Participants with Narcolepsy with and without Cataplexy: Subgroup Analysis of Efficacy and Safety Data by Cataplexy Status in a Randomized Controlled Trial. CNS Drugs. 2020 Jul;34(7):773-784. doi: 10.1007/s40263-020-00744-2.'}, {'pmid': '31926465', 'type': 'DERIVED', 'citation': 'Emsellem HA, Thorpy MJ, Lammers GJ, Shapiro CM, Mayer G, Plazzi G, Chen D, Carter LP, Villa KF, Lee L, Menno D, Black J, Dauvilliers Y. Measures of functional outcomes, work productivity, and quality of life from a randomized, phase 3 study of solriamfetol in participants with narcolepsy. Sleep Med. 2020 Mar;67:128-136. doi: 10.1016/j.sleep.2019.11.1250. Epub 2019 Dec 4.'}]}, 'descriptionModule': {'briefSummary': 'This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter, 4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Major Inclusion Criteria:\n\n1. Males and females between 18 and 75 years of age, inclusive\n2. Diagnosis of narcolepsy according to ICSD-3 or DSM-5 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. Moderate or severe sleep apnea on the baseline PSG.\n3. Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness\n4. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria\n5. History or 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, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the Investigator\n6. History of bariatric surgery within the past year or a history of any gastic bypass procedure\n7. Presence or history of significant cardiovascular disease\n8. Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness\n9. Use of any medications that could affect the evaluation of cataplexy\n10. Received an investigational drug in the past 30 days or five half-lives (whichever is longer)\n11. Previous exposure to or participation in a previous clinical trial of JZP-110 (ADX-N05, R228060, YKP10A)\n12. History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products'}, 'identificationModule': {'nctId': 'NCT02348593', 'briefTitle': '"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jazz Pharmaceuticals'}, 'officialTitle': 'A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy', 'orgStudyIdInfo': {'id': '14-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '75 mg of JZP-110', 'description': 'Once Daily Dosing', 'interventionNames': ['Drug: JZP-110']}, {'type': 'ACTIVE_COMPARATOR', 'label': '150 mg JZP-110', 'description': 'Once Daily Dosing', 'interventionNames': ['Drug: JZP-110']}, {'type': 'ACTIVE_COMPARATOR', 'label': '300 mg of JZP-110', 'description': 'Once Daily Dosing', 'interventionNames': ['Drug: JZP-110']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Once Daily Dosing', 'interventionNames': ['Drug: Placebo oral tablet']}], 'interventions': [{'name': 'JZP-110', 'type': 'DRUG', 'armGroupLabels': ['150 mg JZP-110', '300 mg of JZP-110', '75 mg of JZP-110']}, {'name': 'Placebo oral tablet', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, '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 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{'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Research Network, Inc.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'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': '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': 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