Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT03575104
Status:
COMPLETED
Last Update Posted:
2022-03-25
First Post:
2018-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000634383', 'term': 'daridorexant'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-disclosure@idorsia.com', 'phone': '+41 58 844 00 00', 'title': 'Clinical Trial Disclosure Desk', 'organization': 'Idorsia Pharmaceuticals Ltd'}, 'certainAgreement': {'otherDetails': 'Any study-related publication written independently by investigators must be submitted to Idorsia for review at least 30 days prior to submission for publication or presentation at a congress. Upon review, Idorsia may provide comments, and may also request alterations and/or deletions for the sole purpose of protecting its confidential information and/or patent rights. Neither the institution nor the investigator should permit publication during such a review period.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent AEs were AEs that started or worsened on or after the DB study treatment start date up to the earlier of 30 days after DB study treatment end date or the date of enrollment in the ID-078A303 extension study. The planned duration of DB treatment was 84 days ± 2 days, i.e., 12 weeks ± 2 days.', 'description': 'The number of subjects affected is the number of subjects with at least one event.', 'eventGroups': [{'id': 'EG000', 'title': 'Daridorexant 10 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.', 'otherNumAtRisk': 306, 'deathsNumAtRisk': 306, 'otherNumAffected': 49, 'seriousNumAtRisk': 306, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Daridorexant 25 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.', 'otherNumAtRisk': 308, 'deathsNumAtRisk': 308, 'otherNumAffected': 28, 'seriousNumAtRisk': 308, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Matching placebo was administered as tablets, orally, once daily in the evening.', 'otherNumAtRisk': 306, 'deathsNumAtRisk': 306, 'otherNumAffected': 30, 'seriousNumAtRisk': 306, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 306, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numEvents': 41, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 306, 'numEvents': 22, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'seriousEvents': [{'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 306, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 306, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 306, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Microvascular coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 306, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 306, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 306, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 306, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 306, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 306, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 306, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 306, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Daridorexant 10 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.'}, {'id': 'OG001', 'title': 'Daridorexant 25 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo was administered as tablets, orally, once daily in the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.31', 'groupId': 'OG000', 'lowerLimit': '-19.531', 'upperLimit': '-11.087'}, {'value': '-24.19', 'groupId': 'OG001', 'lowerLimit': '-28.466', 'upperLimit': '-19.911'}, {'value': '-12.57', 'groupId': 'OG002', 'lowerLimit': '-16.817', 'upperLimit': '-8.323'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference to placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.62', 'ciLowerLimit': '-17.604', 'ciUpperLimit': '-5.633', 'pValueComment': 'Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.', 'groupDescription': 'Between-treatment analysis for change from baseline in WASO (min) to Month 1 (Daridorexant 25 mg vs placebo).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Hypothesis testing result: threshold for significance p = 0.025; statistically significant = YES', 'nonInferiorityComment': 'The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).'}, {'pValue': '0.3669', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference to placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.74', 'ciLowerLimit': '-8.693', 'ciUpperLimit': '3.215', 'pValueComment': 'Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.', 'groupDescription': 'Between-treatment analysis for change from baseline in WASO (min) to Month 1 (Daridorexant 10 mg vs placebo).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Hypothesis testing result: threshold for significance p = 0.00977; statistically significant = NO', 'nonInferiorityComment': 'The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Month 1 (i.e. for up to 1 month)', 'description': '"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Month 3 in Wake After Sleep Onset (WASO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Daridorexant 10 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.'}, {'id': 'OG001', 'title': 'Daridorexant 25 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo was administered as tablets, orally, once daily in the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.95', 'groupId': 'OG000', 'lowerLimit': '-20.734', 'upperLimit': '-11.165'}, {'value': '-24.25', 'groupId': 'OG001', 'lowerLimit': '-29.021', 'upperLimit': '-19.474'}, {'value': '-14.00', 'groupId': 'OG002', 'lowerLimit': '-18.756', 'upperLimit': '-9.241'}]}]}], 'analyses': [{'pValue': '0.0028', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean difference to placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.25', 'ciLowerLimit': '-16.95', 'ciUpperLimit': '-3.548', 'pValueComment': 'Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.', 'groupDescription': 'Between-treatment analysis for change from baseline in WASO (min) to Month 3 (Daridorexant 25 mg vs placebo).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Hypothesis testing result: threshold for significance p = 0.01563; statistically significant = YES', 'nonInferiorityComment': 'The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).'}, {'pValue': '0.5686', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference to placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.95', 'ciLowerLimit': '-8.666', 'ciUpperLimit': '4.764', 'pValueComment': 'Mixed effects model for repeated measures: change from baseline in WASO = baseline WASO + age group (\\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.', 'groupDescription': 'Between-treatment analysis for change from baseline in WASO (min) to Month 3 (Daridorexant 10 mg vs placebo).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Hypothesis testing result: threshold for significance p = 0; statistically significant = NO', 'nonInferiorityComment': 'The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Month 3 (i.e. for up to 3 months)', 'description': '"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Daridorexant 10 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.'}, {'id': 'OG001', 'title': 'Daridorexant 25 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo was administered as tablets, orally, once daily in the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.62', 'groupId': 'OG000', 'lowerLimit': '-26.733', 'upperLimit': '-18.503'}, {'value': '-26.46', 'groupId': 'OG001', 'lowerLimit': '-30.626', 'upperLimit': '-22.292'}, {'value': '-20.01', 'groupId': 'OG002', 'lowerLimit': '-24.148', 'upperLimit': '-15.875'}]}]}], 'analyses': [{'pValue': '0.0303', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference to placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.45', 'ciLowerLimit': '-12.282', 'ciUpperLimit': '-0.614', 'pValueComment': 'Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.', 'groupDescription': 'Between-treatment analysis for change from baseline in LPS (min) to Month 1 (Daridorexant 25 mg vs placebo).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Hypothesis testing result: threshold for significance p = 0.025; statistically significant = NO', 'nonInferiorityComment': 'The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).'}, {'pValue': '0.3782', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference to placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.61', 'ciLowerLimit': '-8.41', 'ciUpperLimit': '3.197', 'pValueComment': 'Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.', 'groupDescription': 'Between-treatment analysis for change from baseline in LPS (min) to Month 1 (Daridorexant 10 mg vs placebo).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Hypothesis testing result: threshold for significance p = 0.00195; statistically significant = NO', 'nonInferiorityComment': 'The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Month 1 (i.e. for up to 1 month)', 'description': '"Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Month 3 in Latency to Persistent Sleep (LPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Daridorexant 10 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.'}, {'id': 'OG001', 'title': 'Daridorexant 25 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo was administered as tablets, orally, once daily in the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '-23.09', 'groupId': 'OG000', 'lowerLimit': '-27.600', 'upperLimit': '-18.571'}, {'value': '-28.91', 'groupId': 'OG001', 'lowerLimit': '-33.413', 'upperLimit': '-24.399'}, {'value': '-19.89', 'groupId': 'OG002', 'lowerLimit': '-24.384', 'upperLimit': '-15.405'}]}]}], 'analyses': [{'pValue': '0.0053', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference to placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.01', 'ciLowerLimit': '-15.339', 'ciUpperLimit': '-2.684', 'pValueComment': 'Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.', 'groupDescription': 'Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 25 mg vs placebo).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Hypothesis testing result: threshold for significance p = 0.00313; statistically significant = NO', 'nonInferiorityComment': 'The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).'}, {'pValue': '0.3233', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference to placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.19', 'ciLowerLimit': '-9.528', 'ciUpperLimit': '3.146', 'pValueComment': 'Mixed effects model for repeated measures: change from baseline in LPS = baseline LPS + age group (\\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.', 'groupDescription': 'Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 10 mg vs placebo).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Hypothesis testing result: threshold for significance p = 0; statistically significant = NO', 'nonInferiorityComment': 'The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Month 3 (i.e. for up to 3 months)', 'description': '"Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 1 in the Subjective Total Sleep Time (sTST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Daridorexant 10 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.'}, {'id': 'OG001', 'title': 'Daridorexant 25 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo was administered as tablets, orally, once daily in the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.01', 'groupId': 'OG000', 'lowerLimit': '35.439', 'upperLimit': '46.584'}, {'value': '43.77', 'groupId': 'OG001', 'lowerLimit': '38.136', 'upperLimit': '49.412'}, {'value': '27.64', 'groupId': 'OG002', 'lowerLimit': '22.015', 'upperLimit': '33.274'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference to placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.13', 'ciLowerLimit': '8.224', 'ciUpperLimit': '24.035', 'pValueComment': 'Hypothesis testing result: threshold for significance p = 0.0125; statistically significant = YES', 'groupDescription': 'Between-treatment analysis for change from baseline in sTST (min) to Month 1 (Daridorexant 25 mg vs placebo).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).'}, {'pValue': '= 0.0009', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference to placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.37', 'ciLowerLimit': '5.507', 'ciUpperLimit': '21.226', 'pValueComment': 'Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.', 'groupDescription': 'Between-treatment analysis for change from baseline in sTST (min) to Month 1 (Daridorexant 10 mg vs placebo).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Hypothesis testing result: threshold for significance p = 0; statistically significant = NO', 'nonInferiorityComment': 'The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Month 1 (i.e. for up to 1 month)', 'description': '"Subjective Total Sleep Time" is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 3 in the Subjective Total Sleep Time (sTST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Daridorexant 10 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.'}, {'id': 'OG001', 'title': 'Daridorexant 25 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo was administered as tablets, orally, once daily in the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.70', 'groupId': 'OG000', 'lowerLimit': '44.398', 'upperLimit': '57.008'}, {'value': '56.18', 'groupId': 'OG001', 'lowerLimit': '49.812', 'upperLimit': '62.547'}, {'value': '37.12', 'groupId': 'OG002', 'lowerLimit': '30.776', 'upperLimit': '43.464'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference to placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.06', 'ciLowerLimit': '10.125', 'ciUpperLimit': '27.994', 'pValueComment': 'Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.', 'groupDescription': 'Between-treatment analysis for change from baseline in sTST (min) to Month 3 (Daridorexant 25 mg vs placebo).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Hypothesis testing result: threshold for significance p = 0.00781; statistically significant = YES', 'nonInferiorityComment': 'The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).'}, {'pValue': '= 0.0028', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference to placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.58', 'ciLowerLimit': '4.691', 'ciUpperLimit': '22.475', 'pValueComment': 'Mixed effects model for repeated measures: change from baseline in sTST = baseline sTST + age group (\\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.', 'groupDescription': 'Between-treatment analysis for change from baseline in sTST (min) to Month 3 (Daridorexant 10 mg vs placebo).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Hypothesis testing result: threshold for significance p = 0; statistically significant = NO', 'nonInferiorityComment': 'The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Month 3 (i.e. for up to 3 months)', 'description': 'Subjective Total Sleep Time is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 1 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Daridorexant 10 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.'}, {'id': 'OG001', 'title': 'Daridorexant 25 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo was administered as tablets, orally, once daily in the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.18', 'groupId': 'OG000', 'lowerLimit': '-3.763', 'upperLimit': '-2.599'}, {'value': '-3.51', 'groupId': 'OG001', 'lowerLimit': '-4.096', 'upperLimit': '-2.917'}, {'value': '-2.75', 'groupId': 'OG002', 'lowerLimit': '-3.340', 'upperLimit': '-2.163'}]}]}], 'analyses': [{'pValue': '= 0.0733', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference to placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.75', 'ciLowerLimit': '-1.581', 'ciUpperLimit': '0.071', 'pValueComment': 'Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.', 'groupDescription': 'Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 1 (Daridorexant 25 mg vs placebo).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Hypothesis testing result: threshold for significance p = 0.00625; statistically significant = NO', 'nonInferiorityComment': 'The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).'}, {'pValue': '= 0.3048', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference to placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.43', 'ciLowerLimit': '-1.251', 'ciUpperLimit': '0.392', 'pValueComment': 'Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.', 'groupDescription': 'Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 1 (Daridorexant 10 mg vs placebo).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Hypothesis testing result: threshold for significance p = 0; statistically significant = NO', 'nonInferiorityComment': 'The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Month 1 (i.e. for up to 1 month)', 'description': 'The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a validated patient reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., sleepiness, mood, and alert/cognition) reflecting daytime impairment of insomnia. The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 3 in IDSIQ Sleepiness Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Daridorexant 10 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.'}, {'id': 'OG001', 'title': 'Daridorexant 25 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo was administered as tablets, orally, once daily in the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.75', 'groupId': 'OG000', 'lowerLimit': '-5.437', 'upperLimit': '-4.056'}, {'value': '-5.27', 'groupId': 'OG001', 'lowerLimit': '-5.964', 'upperLimit': '-4.569'}, {'value': '-4.01', 'groupId': 'OG002', 'lowerLimit': '-4.705', 'upperLimit': '-3.322'}]}]}], 'analyses': [{'pValue': '= 0.0120', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference to placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.25', 'ciLowerLimit': '-2.230', 'ciUpperLimit': '-0.276', 'pValueComment': 'Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.', 'groupDescription': 'Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 3 (Daridorexant 25 mg vs placebo).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Hypothesis testing result: threshold for significance p = 0.00391; statistically significant = NO', 'nonInferiorityComment': 'The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).'}, {'pValue': '= 0.1393', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference to placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.73', 'ciLowerLimit': '-1.706', 'ciUpperLimit': '0.239', 'pValueComment': 'Mixed effects model for repeated measures: change from baseline in IDSIQ sleepiness domain score = baseline IDSIQ sleepiness domain score + age group (\\< 65; ≥ 65 years) + treatment + visit + treatment × visit + baseline × visit.', 'groupDescription': 'Between-treatment analysis for change from baseline in IDSIQ sleepiness domain score to Month 3 (Daridorexant 10 mg vs placebo).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Hypothesis testing result: threshold for significance p = 0; statistically significant = NO', 'nonInferiorityComment': 'The Type I error rate was controlled for the testing of multiple null hypotheses associated with the endpoint assessed at 1 and 3 months of treatment and the two dose levels studied. Each null hypothesis was tested against the alternative hypothesis that daridorexant improved the endpoint at the given dose and time point compared to placebo. The order of testing and the alpha level applied to each null hypothesis was based on the Bonferroni-based gatekeeping procedure (see SAP for details).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Month 3 (i.e. for up to 3 months)', 'description': 'The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a validated patient reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., sleepiness, mood, and alert/cognition) reflecting daytime impairment of insomnia. The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Change From Baseline to Month 1 in Log-transformed LPS (LSGM Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Daridorexant 10 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.'}, {'id': 'OG001', 'title': 'Daridorexant 25 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo was administered as tablets, orally, once daily in the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.59', 'groupId': 'OG000', 'lowerLimit': '0.54', 'upperLimit': '0.64'}, {'value': '0.50', 'groupId': 'OG001', 'lowerLimit': '0.46', 'upperLimit': '0.55'}, {'value': '0.63', 'groupId': 'OG002', 'lowerLimit': '0.58', 'upperLimit': '0.69'}]}]}], 'analyses': [{'pValue': '0.2506', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference to placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.05', 'pValueComment': 'Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.', 'groupDescription': 'Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 1 (Daridorexant 10 mg vs placebo).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0004', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference to placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.71', 'ciUpperLimit': '0.91', 'pValueComment': 'Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.', 'groupDescription': 'Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 1 (Daridorexant 25 mg vs placebo).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Month 1 (i.e. for up to 1 month)', 'description': 'Post-hoc analyses were performed using log-transformed LPS data, as the LPS values at baseline more closely resembled a log-normal distribution (skewed to the right) than a normal distribution.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Change From Baseline to Month 3 in Log-transformed LPS (LSGM Ratio to Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Daridorexant 10 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.'}, {'id': 'OG001', 'title': 'Daridorexant 25 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Matching placebo was administered as tablets, orally, once daily in the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.56', 'groupId': 'OG000', 'lowerLimit': '0.51', 'upperLimit': '0.61'}, {'value': '0.48', 'groupId': 'OG001', 'lowerLimit': '0.43', 'upperLimit': '0.52'}, {'value': '0.58', 'groupId': 'OG002', 'lowerLimit': '0.53', 'upperLimit': '0.64'}]}]}], 'analyses': [{'pValue': '0.5037', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference to placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.09', 'pValueComment': 'Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.', 'groupDescription': 'Between-treatment analysis for change from baseline in log transformed LPS (min) to Month 3 (Daridorexant 10 mg vs placebo).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0021', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference to placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.71', 'ciUpperLimit': '0.93', 'pValueComment': 'Mixed effects model for repeated measures: log(value/baseline) = log(baseline) + age group(\\< 65; ≥ 65 years) + treatment + visit + treatment x visit + log(baseline) x visit.', 'groupDescription': 'Between-treatment analysis for change from baseline in LPS (min) to Month 3 (Daridorexant 25 mg vs placebo).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to Month 3 (i.e. for up to 3 month)', 'description': 'Post-hoc analyses were performed using log-transformed LPS data, as the LPS values at baseline more closely resembled a log-normal distribution (skewed to the right) than a normal distribution.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Daridorexant 10 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.'}, {'id': 'FG001', 'title': 'Daridorexant 25 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Matching placebo was administered as tablets, orally, once daily in the evening.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '307'}, {'groupId': 'FG001', 'numSubjects': '309'}, {'groupId': 'FG002', 'numSubjects': '308'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '283'}, {'groupId': 'FG001', 'numSubjects': '280'}, {'groupId': 'FG002', 'numSubjects': '286'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'BG000'}, {'value': '309', 'groupId': 'BG001'}, {'value': '308', 'groupId': 'BG002'}, {'value': '924', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Daridorexant 10 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.'}, {'id': 'BG001', 'title': 'Daridorexant 25 mg', 'description': 'Daridorexant was administered as tablets, orally, once daily in the evening.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Matching placebo was administered as tablets, orally, once daily in the evening.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}, {'value': '561', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}, {'value': '363', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.1', 'spread': '14.0', 'groupId': 'BG000'}, {'value': '56.3', 'spread': '14.4', 'groupId': 'BG001'}, {'value': '56.7', 'spread': '14.1', 'groupId': 'BG002'}, {'value': '56.7', 'spread': '14.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '215', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}, {'value': '638', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '286', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '288', 'groupId': 'BG000'}, {'value': '295', 'groupId': 'BG001'}, {'value': '290', 'groupId': 'BG002'}, {'value': '873', 'groupId': 'BG003'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Not permitted as per legislation/regulation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '273', 'groupId': 'BG000'}, {'value': '271', 'groupId': 'BG001'}, {'value': '267', 'groupId': 'BG002'}, {'value': '811', 'groupId': 'BG003'}]}]}, {'title': 'Not permitted as per legislation/regulation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-08', 'size': 1971199, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-01-05T06:02', 'hasProtocol': True}, {'date': '2020-06-12', 'size': 722404, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-01-05T06:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 924}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'dispFirstSubmitDate': '2020-10-20', 'completionDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-24', 'studyFirstSubmitDate': '2018-05-17', 'dispFirstSubmitQcDate': '2022-03-24', 'resultsFirstSubmitDate': '2022-01-07', 'studyFirstSubmitQcDate': '2018-06-20', 'dispFirstPostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-24', 'studyFirstPostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Month 1 in Wake After Sleep Onset (WASO) (Sleep Maintenance)', 'timeFrame': 'From baseline to Month 1 (i.e. for up to 1 month)', 'description': '"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.'}, {'measure': 'Change From Baseline to Month 3 in Wake After Sleep Onset (WASO)', 'timeFrame': 'From baseline to Month 3 (i.e. for up to 3 months)', 'description': '"Wake After Sleep Onset" is the time spent awake after onset of persistent sleep until lights on, as determined by polysomnography.'}, {'measure': 'Change From Baseline to Month 1 in Latency to Persistent Sleep (LPS) (Sleep Onset)', 'timeFrame': 'From baseline to Month 1 (i.e. for up to 1 month)', 'description': '"Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.'}, {'measure': 'Change From Baseline to Month 3 in Latency to Persistent Sleep (LPS)', 'timeFrame': 'From baseline to Month 3 (i.e. for up to 3 months)', 'description': '"Latency to Persistent Sleep" is the time from start of recording to the beginning of the first continuous 20 epochs (i.e., 10 minutes) scored as non-awake, i.e., epochs scored as either sleep stage 1 (S1), sleep stage 2 (S2), sleep stage 3 (slow wave sleep) or REM, as determined by polysomnography.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Month 1 in the Subjective Total Sleep Time (sTST)', 'timeFrame': 'From baseline to Month 1 (i.e. for up to 1 month)', 'description': '"Subjective Total Sleep Time" is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time.'}, {'measure': 'Change From Baseline to Month 3 in the Subjective Total Sleep Time (sTST)', 'timeFrame': 'From baseline to Month 3 (i.e. for up to 3 months)', 'description': 'Subjective Total Sleep Time is the total sleep time reported by the participant in the sleep diary questionnaire. A positive change from baseline indicates an increase in the subjective Total Sleep Time. A negative change from baseline indicates a decrease in subjective Total Sleep Time.'}, {'measure': 'Change From Baseline to Month 1 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Sleepiness Domain Score', 'timeFrame': 'From baseline to Month 1 (i.e. for up to 1 month)', 'description': 'The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a validated patient reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., sleepiness, mood, and alert/cognition) reflecting daytime impairment of insomnia. The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.'}, {'measure': 'Change From Baseline to Month 3 in IDSIQ Sleepiness Domain Score', 'timeFrame': 'From baseline to Month 3 (i.e. for up to 3 months)', 'description': 'The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a validated patient reported outcome instrument comprising 14 items (each using a numeric rating scale from 0 to 10) grouped into three domains (i.e., sleepiness, mood, and alert/cognition) reflecting daytime impairment of insomnia. The IDSIQ sleepiness domain has 4 items, and the domain score ranges from 0 to a maximum of 40, where a higher score indicates a greater burden. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insomnia Disorder']}, 'referencesModule': {'references': [{'pmid': '33131027', 'type': 'BACKGROUND', 'citation': 'Hudgens S, Phillips-Beyer A, Newton L, Seboek Kinter D, Benes H. Development and Validation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). Patient. 2021 Mar;14(2):249-268. doi: 10.1007/s40271-020-00474-z. Epub 2020 Nov 1.'}, {'pmid': '35065036', 'type': 'RESULT', 'citation': 'Mignot E, Mayleben D, Fietze I, Leger D, Zammit G, Bassetti CLA, Pain S, Kinter DS, Roth T; investigators. Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials. Lancet Neurol. 2022 Feb;21(2):125-139. doi: 10.1016/S1474-4422(21)00436-1. Erratum In: Lancet Neurol. 2022 Mar;21(3):e3. doi: 10.1016/S1474-4422(22)00029-1. Lancet Neurol. 2022 Jun;21(6):e6. doi: 10.1016/S1474-4422(22)00144-2.'}, {'pmid': '38644625', 'type': 'DERIVED', 'citation': 'Di Marco T, Djonlagic I, Dauvilliers Y, Sadeghi K, Little D, Datta AN, Hubbard J, Hajak G, Krystal A, Olivieri A, Parrino L, Puryear CB, Zammit G, Donoghue J, Scammell TE. Effect of daridorexant on sleep architecture in patients with chronic insomnia disorder: a pooled post hoc analysis of two randomized phase 3 clinical studies. Sleep. 2024 Nov 8;47(11):zsae098. doi: 10.1093/sleep/zsae098.'}, {'pmid': '37796657', 'type': 'DERIVED', 'citation': 'Citrome L, Juday TR, Lundwall C. Lemborexant and Daridorexant for the Treatment of Insomnia: An Indirect Comparison Using Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. J Clin Psychiatry. 2023 Oct 2;84(6):23m14851. doi: 10.4088/JCP.23m14851.'}, {'pmid': '37526060', 'type': 'DERIVED', 'citation': 'Dutta S, Singhal S, Shah R, Charan J, Dhingra S, Haque M. Daridorexant as a novel pharmacotherapeutic approach in insomnia: a systematic review and meta-analysis. Expert Opin Drug Saf. 2023 Jul-Dec;22(12):1237-1251. doi: 10.1080/14740338.2023.2243217. Epub 2023 Aug 7.'}, {'pmid': '36054921', 'type': 'DERIVED', 'citation': 'Heidenreich S, Ross M, Chua GN, Seboek Kinter D, Phillips-Beyer A. Preferences of patients for benefits and risks of insomnia medications using data elicited during two phase III clinical trials. Sleep. 2022 Nov 9;45(11):zsac204. doi: 10.1093/sleep/zsac204.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consent prior to any study-mandated procedure;\n* Male or female aged ≥ 18 years;\n* Insomnia disorder according to DSM-5 criteria;\n* Insomnia Severity Index score ≥ 15;\n* Insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by polysomnography;\n* Women of childbearing potential must have a negative and urine pregnancy test and use the contraception scheme up to at least 30 days after last study treatment intake.\n\nExclusion Criteria:\n\n* Body mass index below 18.5 or above 40.0 kg/m2;\n* Any lifetime history of of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, narcolepsy, or apnea/hypopnea;\n* Cognitive behavioral therapy (CBT) only allowed if, the treatment started at least 1 month prior to Visit 3 and the subject agrees to continue this CBT throughout the study;\n* Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week;\n* Acute or unstable psychiatric conditions diagnosed by the Mini International Neuropsychiatric Interview;\n* Mini Mental State Examination (MMSE) score \\< 25 in subjects ≥ 50 years;\n* For female subjects: pregnant, lactating or planning to become pregnant during projected duration of the study;\n* History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments.\n* Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol."}, 'identificationModule': {'nctId': 'NCT03575104', 'briefTitle': 'Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep', 'organization': {'class': 'INDUSTRY', 'fullName': 'Idorsia Pharmaceuticals Ltd.'}, 'officialTitle': 'Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Polysomnography Study to Assess the Efficacy and Safety of ACT-541468 in Adult and Elderly Subjects With Insomnia Disorder', 'orgStudyIdInfo': {'id': 'ID-078A302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Daridorexant 10 mg', 'interventionNames': ['Drug: Daridorexant']}, {'type': 'EXPERIMENTAL', 'label': 'Daridorexant 25 mg', 'interventionNames': ['Drug: Daridorexant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Daridorexant', 'type': 'DRUG', 'description': 'Daridorexant will be administered as tablets, orally, once daily in the evening.', 'armGroupLabels': ['Daridorexant 10 mg', 'Daridorexant 25 mg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Matching placebo will be administered as tablets, orally, once daily in the evening.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pulmonary Associates, Pa', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Noble Clinical Research', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Baptist Health Center for Clinical Research', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Woodland International Research Group', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90703', 'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'facility': 'Core Healthcare Group', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'zip': '92503', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Artemis Institute For Clinical Research - Riverside', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Research Network', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92078', 'city': 'San Marcos', 'state': 'California', 'country': 'United States', 'facility': 'Artemis Institute for Clinical Research', 'geoPoint': {'lat': 33.14337, 'lon': -117.16614}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Santa Monica Clinical Trials', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'Empire Clinical Research', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '80026', 'city': 'Lafayette', 'state': 'Colorado', 'country': 'United States', 'facility': 'Innovative Clinical Research', 'geoPoint': {'lat': 39.9936, 'lon': -105.08971}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of South Florida', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '32003', 'city': 'Fleming Island', 'state': 'Florida', 'country': 'United States', 'facility': 'Fleming Island Center for Clinical Research', 'geoPoint': {'lat': 30.0933, 'lon': -81.71898}}, {'zip': '95648', 'city': 'Lincoln', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Trials Research', 'geoPoint': {'lat': 27.9491, 'lon': -82.4984}}, {'zip': '33707', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Group of St. Petersburgh', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Neurotrials Research Incorporated', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '31210', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Sleep Practitioners, LLC', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '96817', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Hawaii Pacific Neurosciences', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '83686', 'city': 'Nampa', 'state': 'Idaho', 'country': 'United States', 'facility': 'Saltzer Clinical Research', 'geoPoint': {'lat': 43.54072, 'lon': -116.56346}}, {'zip': '66214', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'Rowe Neurology Institute', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '21061', 'city': 'Glen Burnie', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sleep Disorders Center of the Mid-Atlantic', 'geoPoint': {'lat': 39.16261, 'lon': -76.62469}}, {'zip': '02459', 'city': 'Newton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Neurocare Inc.', 'geoPoint': {'lat': 42.33704, 'lon': -71.20922}}, {'zip': '39232', 'city': 'Flowood', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Precise Research Centers', 'geoPoint': {'lat': 32.30959, 'lon': -90.13898}}, {'zip': '11530', 'city': 'Garden City', 'state': 'New York', 'country': 'United States', 'facility': 'Garden City Asthma and Sleep Center', 'geoPoint': {'lat': 40.72677, 'lon': -73.6343}}, {'zip': '28601', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Carolina of Hickory', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Research Associates', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Clinical Trials of America - NC, LLC', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45212', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'CTI Clinical Research II', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43017', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Sleep Medicine Institue', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}, {'zip': '44130', 'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Sleep Research Center', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'zip': '44691', 'city': 'Wooster', 'state': 'Ohio', 'country': 'United States', 'facility': 'Robert V. Sibilia, MD, Inc.', 'geoPoint': {'lat': 40.80517, 'lon': -81.93646}}, {'zip': '19301', 'city': 'Paoli', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Brian Abaluck LLC', 'geoPoint': {'lat': 40.04205, 'lon': -75.47631}}, {'zip': '38018', 'city': 'Cordova', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Wesley Neurology Clinic Pc (Multiple Sclerosis)', 'geoPoint': {'lat': 35.15565, 'lon': -89.7762}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'FutureSearch Trials of Neurology, LP', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75115', 'city': 'DeSoto', 'state': 'Texas', 'country': 'United States', 'facility': 'InSite Clinical Research', 'geoPoint': {'lat': 32.58986, 'lon': -96.85695}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Texas', 'country': 'United States', 'facility': 'Jacksonville Center for Clinical Research', 'geoPoint': {'lat': 31.96378, 'lon': -95.2705}}, {'zip': '77375', 'city': 'Tomball', 'state': 'Texas', 'country': 'United States', 'facility': 'Dm Clinical Research / Martin Diagnostic Clinic', 'geoPoint': {'lat': 30.09716, 'lon': -95.61605}}, {'zip': '8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'HOSPITAL AZ SINT-JAN_Neurology department', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hospital Universitair Zieknhuis Brussel, Pneumology and Sleep Laboratory', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Gent, Department of General Internal Medicine and Center of neurophysiological Monitoring', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Hospital UZ Leuven_ Pneumology Department', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '1407', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Acibadem City Clinic Tokuda Hospital EAD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': 'M3J 2C5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Canadian Phase Onward Inc.', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M9C 5N2', 'city': 'Etobicoke', 'country': 'Canada', 'facility': 'Queensway Sleep Lab Sleep Clinic (MedSleep)- 5359 Dundas Street West, Suite 202, Etobicoke, ON M9B 1B1', 'geoPoint': {'lat': 43.64415, 'lon': -79.56985}}, {'zip': 'V1Y 3G8', 'city': 'Kelowna', 'country': 'Canada', 'facility': 'The Medical Arts Health Research Group', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'zip': 'L3R 1A3', 'city': 'Markham', 'country': 'Canada', 'facility': 'Somni Research Inc.', 'geoPoint': {'lat': 43.86682, 'lon': -79.2663}}, {'zip': 'M3H 3W1', 'city': 'Toronto', 'country': 'Canada', 'facility': 'Somni Research, Calgary', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M3J 0K2', 'city': 'Toronto', 'country': 'Canada', 'facility': 'CANADIAN PHASE ONWARD INC. (Toronto)', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '37087', 'city': 'České Budějovice', 'country': 'Czechia', 'facility': 'Nemocnice České Budějovice, Centrum pro poruchy spánku a spánkovou medicínu', 'geoPoint': {'lat': 48.97447, 'lon': 14.47434}}, {'city': 'Klecany', 'country': 'Czechia', 'facility': 'Narodni Ustav Dusevniho Zdravi (National Institute of Mental Health)', 'geoPoint': {'lat': 50.17599, 'lon': 14.41148}}, {'zip': '70852', 'city': 'Ostrava-Poruba', 'country': 'Czechia', 'facility': 'Fakultní nemocnice Ostrava, Spánková laboratoř'}, {'zip': '380', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Vitalmed Uniklinikka', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '70100', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'Oivauni Oy - Kuopio', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'city': 'Tampere', 'country': 'Finland', 'facility': 'Oivauni Oy - Tampere', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'city': 'Turku', 'country': 'Finland', 'facility': 'Unitutkimusyksikkö, Turun Yliopisto', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU De Lille - Hospital Salengro - Neurophysiologie Clinique', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'Clinique beau soleil - Department Sleep and Neurology', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU NIMES - Unité de Sommeil', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Advanced Sleep Research GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Klinische Forschung Berlin-Mitte GmbH', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12200', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin Kompetenzzentrum Schlafmedizin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44787', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Synexus Clinical Research GmbH', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '1069', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Klinische Forschung Dresden GmbH', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '60313', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Synexus Clinical Research GmbH', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '30159', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Klinische Forschung Hannover Mitte GmbH', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '76889', 'city': 'Klingenmünster', 'country': 'Germany', 'facility': 'Interdisziplinäre Schlafmedizin, Pfalzklinikum', 'geoPoint': {'lat': 49.14056, 'lon': 8.01861}}, {'zip': '23538', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'Zentrum für Integrative Psychiatrie (ZiP) Universität zu Lübeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '68159', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'Central Insitute of Mental Health Sleep laboratory Medical Faculty Mannheim/Heidelberg University', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '93053', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie der Universität am Bezirksklinikum Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '19053', 'city': 'Schwerin', 'country': 'Germany', 'facility': 'SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH', 'geoPoint': {'lat': 53.62937, 'lon': 11.41316}}, {'zip': '1134', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Magyar Honvédség Egészségügyi Központ, Neurológiai Osztály', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '6725', 'city': 'Szeged', 'country': 'Hungary', 'facility': 'Somnius Kft. SomnoCenter Szeged', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '49201', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Dong-A University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '41931', 'city': 'Daegu', 'country': 'South Korea', 'facility': '4F Neuroimaging analysis laboratory, 56 Dalseong-ro, Jung-gu', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '35015', 'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'zip': '61469', 'city': 'Gwangju', 'country': 'South Korea', 'facility': '3F, 2nd Building, Psychiatry Outpatient, Family Counseling Room, 42 Jebong-ro, Donggu', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '13620', 'city': 'Seongnam', 'country': 'South Korea', 'facility': '8F Sleep Lab, 1st Building,82, Gumi-ro 173 Beon-gil, Bundang-gu', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'zip': '3080', 'city': 'Seoul', 'country': 'South Korea', 'facility': '3F Sleep Medicine Center, 101 Daehak-Ro Jongno-Gu', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '3722', 'city': 'Seoul', 'country': 'South Korea', 'facility': '1st CRC room, 2F, Jejoong building, 50-1 Yonsei-ro,, Seodaemun-gu', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '5030', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'B2F, Clinical Trial Center, Konkuk University Medical Center 120-1, Neungdong-ro, Gwangjin-gu', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '5278', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'B1F Neurological examination room, 892 Dongnam-ro, Gangdong-gu', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '16247', 'city': 'Suwon', 'country': 'South Korea', 'facility': '2F Psychiatry Outpatient, 93, Jungbu-daero, Paldal-gu', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '41390', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Göteborgs Universitet, Centrum för sömn och vakenhetsstörningar', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '70185', 'city': 'Örebro', 'country': 'Sweden', 'facility': 'Universitetssjukhuset Örebro Neurokliniken, Sömnenheten', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}, {'zip': '11486', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'SOPHIAHEMMET (Stockholm)', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '75185', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Sömnutredningsmottagningen, smärtcentrum Akademiska sjukhuset', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Idorsia Pharmaceuticals Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Idorsia Pharmaceuticals Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}