Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-02-24 @ 5:08 AM
Study NCT ID:
NCT04147858
Status:
COMPLETED
Last Update Posted:
2023-04-28
First Post:
2019-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia
Sponsor:
Organization:
Raw JSON
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The protocol required adverse events to be followed to resolution of the adverse event.', 'description': 'MedDRA (24.1)', 'eventGroups': [{'id': 'EG000', 'title': 'NYX-2925 50 mg', 'description': 'NYX-2925 50 mg administered orally once daily.', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 18, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'NYX-2925 100 mg', 'description': 'NYX-2925 100 mg administered orally once daily.', 'otherNumAtRisk': 104, 'deathsNumAtRisk': 104, 'otherNumAffected': 19, 'seriousNumAtRisk': 104, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo administered orally once daily.', 'otherNumAtRisk': 105, 'deathsNumAtRisk': 105, 'otherNumAffected': 18, 'seriousNumAtRisk': 105, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 104, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 105, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in the Mean Numerical Rating Scale (NRS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NYX-2925 50 mg', 'description': 'NYX-2925 50 mg administered orally once daily.'}, {'id': 'OG001', 'title': 'NYX-2925 100 mg', 'description': 'NYX-2925 100 mg administered orally once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.26', 'spread': '1.603', 'groupId': 'OG000'}, {'value': '-1.47', 'spread': '1.983', 'groupId': 'OG001'}, {'value': '-1.23', 'spread': '1.846', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.539', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.425', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Change from baseline to Week 12 in the weekly mean of the daily Numerical Rating Scale (NRS) score assessing average pain intensity in the past 24 hours, scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGI-C) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NYX-2925 50 mg', 'description': 'NYX-2925 50 mg administered orally once daily.'}, {'id': 'OG001', 'title': 'NYX-2925 100 mg', 'description': 'NYX-2925 100 mg administered orally once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.824', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.000', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'Number of subjects "much improved" or "very much improved" on the Patient Global Impression of Change (PGI-C) at Week 12', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Daily Sleep Interference (DSIS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NYX-2925 50 mg', 'description': 'NYX-2925 50 mg administered orally once daily.'}, {'id': 'OG001', 'title': 'NYX-2925 100 mg', 'description': 'NYX-2925 100 mg administered orally once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.42', 'spread': '1.835', 'groupId': 'OG000'}, {'value': '-1.45', 'spread': '2.104', 'groupId': 'OG001'}, {'value': '-1.38', 'spread': '2.177', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.297', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.603', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) scores at Week 12; Response options range from 0 (Did not interfere with sleep) to 10 (Completely interfered with sleep, unable to sleep due to pain), with higher scores indicating greater interference with sleep.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Achieving ≥30% Pain Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NYX-2925 50 mg', 'description': 'NYX-2925 50 mg administered orally once daily.'}, {'id': 'OG001', 'title': 'NYX-2925 100 mg', 'description': 'NYX-2925 100 mg administered orally once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.871', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.352', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'Number of subjects achieving ≥30% reduction from baseline in the weekly mean NRS average pain intensity at Week 12; NRS Scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Achieving ≥50% Pain Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NYX-2925 50 mg', 'description': 'NYX-2925 50 mg administered orally once daily.'}, {'id': 'OG001', 'title': 'NYX-2925 100 mg', 'description': 'NYX-2925 100 mg administered orally once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.626', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'Number of subjects achieving ≥50% reduction from baseline in the weekly mean NRS average pain intensity at Week 12; NRS scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fibromyalgia Impact Questionnaire-Revised (FIQR) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NYX-2925 50 mg', 'description': 'NYX-2925 50 mg administered orally once daily.'}, {'id': 'OG001', 'title': 'NYX-2925 100 mg', 'description': 'NYX-2925 100 mg administered orally once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.6', 'spread': '20.10', 'groupId': 'OG000'}, {'value': '-12.3', 'spread': '20.56', 'groupId': 'OG001'}, {'value': '-9.9', 'spread': '20.08', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.059', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.726', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Change from baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) score; FIQR scores range from 0-100, with higher scores indicating greater impact of fibromyalgia', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Sleep Disturbance Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NYX-2925 50 mg', 'description': 'NYX-2925 50 mg administered orally once daily.'}, {'id': 'OG001', 'title': 'NYX-2925 100 mg', 'description': 'NYX-2925 100 mg administered orally once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.59', 'spread': '8.238', 'groupId': 'OG000'}, {'value': '-3.93', 'spread': '8.346', 'groupId': 'OG001'}, {'value': '-4.66', 'spread': '9.567', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.888', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.832', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Change from baseline to Week 12 in the PROMIS-FM sleep disturbance score, scores range from 0-40, with higher scores indicating greater sleep disturbance.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Fatigue Profile Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NYX-2925 50 mg', 'description': 'NYX-2925 50 mg administered orally once daily.'}, {'id': 'OG001', 'title': 'NYX-2925 100 mg', 'description': 'NYX-2925 100 mg administered orally once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.5', 'spread': '8.70', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '9.04', 'groupId': 'OG001'}, {'value': '-2.9', 'spread': '7.90', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.536', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.982', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Change from baseline to Week 12 in the PROMIS-FM fatigue profile score, scores range from 0-80, with higher scores indicating greater impact of fatigue', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Physical Function Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NYX-2925 50 mg', 'description': 'NYX-2925 50 mg administered orally once daily.'}, {'id': 'OG001', 'title': 'NYX-2925 100 mg', 'description': 'NYX-2925 100 mg administered orally once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.18', 'spread': '5.017', 'groupId': 'OG000'}, {'value': '2.08', 'spread': '5.223', 'groupId': 'OG001'}, {'value': '1.83', 'spread': '5.153', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.190', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.764', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Change from baseline to Week 12 in the PROMIS-FM physical function score, scores range from 0-60, with higher scores indicating greater difficulty with physical function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Use of Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NYX-2925 50 mg', 'description': 'NYX-2925 50 mg administered orally once daily.'}, {'id': 'OG001', 'title': 'NYX-2925 100 mg', 'description': 'NYX-2925 100 mg administered orally once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo administered orally once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.097', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.849', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'The number of subjects using rescue medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NYX-2925 50 mg', 'description': 'NYX-2925 50 mg administered orally.'}, {'id': 'FG001', 'title': 'NYX-2925 100 mg', 'description': 'NYX-2925 100 mg administered orally.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo administered orally.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '104'}, {'comment': 'One subject in the placebo group did not have post baseline efficacy measurements and is not included in efficacy results presented.', 'groupId': 'FG002', 'numSubjects': '105'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '82'}, {'groupId': 'FG002', 'numSubjects': '85'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Subject Noncompliance, Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, 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{'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '34', 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'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-14', 'size': 3965488, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-02T19:18', 'hasProtocol': True}, {'date': '2022-07-21', 'size': 4549440, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-03-02T19:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomization algorithm, randomization allocation, allocation to study drug or placebo.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310}}, 'statusModule': 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intensity in the past 24 hours, scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain)'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGI-C) at Week 12', 'timeFrame': 'Week 12', 'description': 'Number of subjects "much improved" or "very much improved" on the Patient Global Impression of Change (PGI-C) at Week 12'}, {'measure': 'Daily Sleep Interference (DSIS) Score', 'timeFrame': 'Week 12', 'description': 'Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) scores at Week 12; Response options range from 0 (Did not interfere with sleep) to 10 (Completely interfered with sleep, unable to sleep due to pain), with higher scores indicating greater interference with sleep.'}, {'measure': 'Number of Subjects Achieving ≥30% Pain Reduction', 'timeFrame': 'Week 12', 'description': 'Number of subjects achieving ≥30% reduction from baseline in the weekly mean NRS average pain intensity at Week 12; NRS Scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain).'}, {'measure': 'Number of Subjects Achieving ≥50% Pain Reduction', 'timeFrame': 'Week 12', 'description': 'Number of subjects achieving ≥50% reduction from baseline in the weekly mean NRS average pain intensity at Week 12; NRS scores range from 0-10, with higher scores indicating worse pain (0 being no pain and 10 being the worst possible pain)'}, {'measure': 'Fibromyalgia Impact Questionnaire-Revised (FIQR) Score', 'timeFrame': 'Week 12', 'description': 'Change from baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) score; FIQR scores range from 0-100, with higher scores indicating greater impact of fibromyalgia'}, {'measure': 'Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Sleep Disturbance Score', 'timeFrame': 'Week 12', 'description': 'Change from baseline to Week 12 in the PROMIS-FM sleep disturbance score, scores range from 0-40, with higher scores indicating greater sleep disturbance.'}, {'measure': 'Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Fatigue Profile Score', 'timeFrame': 'Week 12', 'description': 'Change from baseline to Week 12 in the PROMIS-FM fatigue profile score, scores range from 0-80, with higher scores indicating greater impact of fatigue'}, {'measure': 'Patient Reported Outcomes Measurement Information System - Fibromyalgia (PROMIS-FM) Physical Function Score', 'timeFrame': 'Week 12', 'description': 'Change from baseline to Week 12 in the PROMIS-FM physical function score, scores range from 0-60, with higher scores indicating greater difficulty with physical function.'}, {'measure': 'Use of Rescue Medication', 'timeFrame': 'Week 12', 'description': 'The number of subjects using rescue medication.'}]}, 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