Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-25 @ 2:31 PM
Study NCT ID:
NCT03400059
Status:
COMPLETED
Last Update Posted:
2025-01-06
First Post:
2018-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Efficacy of Intranasal Kinetic Oscillation Stimulation in the Preventive Treatment of Chronic Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jan.hermansson@chordate.com', 'phone': '+46 8 400 115 86', 'title': 'Dr Jan Hermansson', 'organization': 'Chordate Medical AB'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From Day 0 (during and after the first treatment with the investigational medicinal device) to Day 70 (final follow-up visit), i.e, about 10 weeks', 'description': '\\[shortened\\] The definition of AE in this study does not include adverse experiences observed by the patient or in the patient before the investigational medical device application.\n\nIt does not include anticipated device effects of mild character. It does also not include migraine-associated symptoms.\n\nAll AEs were assessed in terms of seriousness (yes, no), severity, outcome, relationship to the investigational medical device, and relationship to study procedures.', 'eventGroups': [{'id': 'EG000', 'title': 'Active Treatment', 'description': 'Chordate System S211 in treatment mode: Chordate System S211 in treatment mode', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 49, 'seriousNumAtRisk': 76, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Sham Treatment', 'description': 'Chordate System S211 in placebo mode: Chordate System S211 in placebo mode', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 41, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Corona Virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Root canal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Muscle tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Epixtaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 11, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nasal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 8, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'foot fracture', 'notes': 'right metatarsal shaft fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline (4-week Screening Period) in Monthly Headache Days With Moderate to Severe Intensity in 4-week Performance Assessment Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Chordate System S211 in treatment mode: Chordate System S211 in treatment mode'}, {'id': 'OG001', 'title': 'Sham Treatment', 'description': 'Chordate System S211 in placebo mode: Chordate System S211 in placebo mode'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.45', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '-1.22', 'spread': '0.62', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0132', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.23', 'ciLowerLimit': '-4.11', 'ciUpperLimit': '-0.49', 'pValueComment': 'analysis of covariance (ANCOVA) model containing terms for treatment, baseline value and medication overuse.\n\nGroup-sequential analysis using updated boundaries from interim analysis', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42', 'description': 'Least square mean change from Baseline (4-week screening period) in monthly headache days with moderate to severe intensity in 4-week performance assessment period.', 'unitOfMeasure': 'change in days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Monthly Headache Days With Moderate to Severe Intensity in Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Chordate System S211 in treatment mode: Chordate System S211 in treatment mode'}, {'id': 'OG001', 'title': 'Sham Treatment', 'description': 'Chordate System S211 in placebo mode: Chordate System S211 in placebo mode'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.15', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '0.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.68', 'ciLowerLimit': '-4.32', 'ciUpperLimit': '-1.04', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model containing terms for treatment, baseline value and medication overuse'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70', 'unitOfMeasure': 'change in days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Performance Assessment Period in Monthly Migraine Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Chordate System S211 in treatment mode: Chordate System S211 in treatment mode'}, {'id': 'OG001', 'title': 'Sham Treatment', 'description': 'Chordate System S211 in placebo mode: Chordate System S211 in placebo mode'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.57', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '-1.17', 'spread': '0.60', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0048', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.40', 'ciLowerLimit': '-4.06', 'ciUpperLimit': '-0.73', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model containing terms for treatment, baseline value and medication overuse'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42', 'unitOfMeasure': 'change in days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Follow-up Period in Monthly Migraine Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Chordate System S211 in treatment mode: Chordate System S211 in treatment mode'}, {'id': 'OG001', 'title': 'Sham Treatment', 'description': 'Chordate System S211 in placebo mode: Chordate System S211 in placebo mode'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.72', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '-0.85', 'spread': '0.60', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.87', 'ciLowerLimit': '-4.54', 'ciUpperLimit': '-1.20', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model containing terms for treatment, baseline value and medication overuse.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70', 'unitOfMeasure': 'change in days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Performance Assessment Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Chordate System S211 in treatment mode: Chordate System S211 in treatment mode'}, {'id': 'OG001', 'title': 'Sham Treatment', 'description': 'Chordate System S211 in placebo mode: Chordate System S211 in placebo mode'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.88', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '-1.35', 'spread': '0.58', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0598', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.53', 'ciLowerLimit': '-3.12', 'ciUpperLimit': '0.06', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model containing terms for treatment, baseline value and medication overuse.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42', 'unitOfMeasure': 'change in days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Follow-up Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Chordate System S211 in treatment mode: Chordate System S211 in treatment mode'}, {'id': 'OG001', 'title': 'Sham Treatment', 'description': 'Chordate System S211 in placebo mode: Chordate System S211 in placebo mode'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.65', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '-1.75', 'spread': '0.62', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0310', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.90', 'ciLowerLimit': '-3.63', 'ciUpperLimit': '-0.17', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA model containing terms for treatment, baseline value and medication overuse.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70', 'unitOfMeasure': 'change in days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With 30% or Greater Reduction in Headache Days of Moderate to Severe Intensity in Performance Assessment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Chordate System S211 in treatment mode: Chordate System S211 in treatment mode'}, {'id': 'OG001', 'title': 'Sham Treatment', 'description': 'Chordate System S211 in placebo mode: Chordate System S211 in placebo mode'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0102', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With 30% or Greater Reduction in Headache Days of Moderate to Severe Intensity in Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Chordate System S211 in treatment mode: Chordate System S211 in treatment mode'}, {'id': 'OG001', 'title': 'Sham Treatment', 'description': 'Chordate System S211 in placebo mode: Chordate System S211 in placebo mode'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1615', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With 50% or Greater Reduction of Headache Days of Moderate to Severe Intensity in Performance Assessment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Chordate System S211 in treatment mode: Chordate System S211 in treatment mode'}, {'id': 'OG001', 'title': 'Sham Treatment', 'description': 'Chordate System S211 in placebo mode: Chordate System S211 in placebo mode'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0798', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With 50% or Greater Reduction of Headache Days of Moderate to Severe Intensity in Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Chordate System S211 in treatment mode: Chordate System S211 in treatment mode'}, {'id': 'OG001', 'title': 'Sham Treatment', 'description': 'Chordate System S211 in placebo mode: Chordate System S211 in placebo mode'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1300', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Change in the Use of Abortive Medication in Performance Assessment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Chordate System S211 in treatment mode: Chordate System S211 in treatment mode'}, {'id': 'OG001', 'title': 'Sham Treatment', 'description': 'Chordate System S211 in placebo mode: Chordate System S211 in placebo mode'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.016', 'spread': '4.565', 'groupId': 'OG000'}, {'value': '-0.857', 'spread': '4.721', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0660', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.0', 'pValueComment': 'posthoc', 'statisticalMethod': 'Van-Elteren', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42', 'unitOfMeasure': 'change in days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Change in the Use of Abortive Medication in Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Chordate System S211 in treatment mode: Chordate System S211 in treatment mode'}, {'id': 'OG001', 'title': 'Sham Treatment', 'description': 'Chordate System S211 in placebo mode: Chordate System S211 in placebo mode'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.490', 'spread': '4.260', 'groupId': 'OG000'}, {'value': '-0.660', 'spread': '5.552', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0152', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-2.0', 'pValueComment': 'posthoc', 'statisticalMethod': 'Van-Elteren', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70', 'unitOfMeasure': 'change in days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Headache Impact Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Chordate System S211 in treatment mode: Chordate System S211 in treatment mode'}, {'id': 'OG001', 'title': 'Sham Treatment', 'description': 'Chordate System S211 in placebo mode: Chordate System S211 in placebo mode'}], 'classes': [{'title': 'Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Visit 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.1', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '4.8', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '5.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)', 'description': "The headache impact test-6 (HIT-6) is a 6-item self-administered questionnaire that evaluates the extent of disability a subject experiences due to headache by measuring the subject's level of pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The final total score is obtained from simple summation of the 6 items. The total score ranges between 36 and 78, with larger scores reflecting greater impact.\n\nReported is the change from Baseline in the final total score at the respective visit.", 'unitOfMeasure': 'change in score on a scale from Baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'assessments of individual subjects missing at some visits'}, {'type': 'SECONDARY', 'title': 'Migraine-Specific Quality of Life Questionnaire (MSQ) - Role Function - Restrictive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Chordate System S211 in treatment mode: Chordate System S211 in treatment mode'}, {'id': 'OG001', 'title': 'Sham Treatment', 'description': 'Chordate System S211 in placebo mode: Chordate System S211 in placebo mode'}], 'classes': [{'title': 'Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.4', 'spread': '16.3', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '11.2', 'groupId': 'OG001'}]}]}, {'title': 'Visit 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.3', 'spread': '19.9', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '17.0', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.9', 'spread': '21.4', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '19.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)', 'description': 'The role function-restrictive dimension of the MSQ assesses how migraines limit daily activities and interactions during the past 4 weeks. It includes 7 items. Each item is scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). The scores of these items are summed and then transformed to a 0-100 scale. This means the minimum score of the role function restrictive dimension is 0 and the maximum score is 100 where a higher score indicates a better health status.\n\nReported is the change from Baseline in the role function restrictive dimension of the MSQ at the respective visit.', 'unitOfMeasure': 'change in score on a scale from Baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'assessments of individual subjects missing at some visits'}, {'type': 'SECONDARY', 'title': 'MSQ - Role Function - Preventive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Chordate System S211 in treatment mode: Chordate System S211 in treatment mode'}, {'id': 'OG001', 'title': 'Sham Treatment', 'description': 'Chordate System S211 in placebo mode: Chordate System S211 in placebo mode'}], 'classes': [{'title': 'Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '17.4', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '10.9', 'groupId': 'OG001'}]}]}, {'title': 'Visit 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.2', 'spread': '20.8', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '16.6', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.8', 'spread': '22.2', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '19.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)', 'description': 'The role function-preventive dimension of the MSQ assesses how migraines prevent from engaging in daily activities during the past 4 weeks. It includes 4 items. Each item is scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). The scores of these items are summed and then transformed to a 0-100 scale. This means the minimum score of the role function-preventive dimension is 0 and the maximum score is 100 where a higher score indicates a better health status.\n\nReported is the change from Baseline in the role function-preventive dimension of the MSQ at the respective visit.', 'unitOfMeasure': 'change in score on a scale from Baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'assessments of individual subjects missing at some visits'}, {'type': 'SECONDARY', 'title': 'MSQ - Emotional Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Chordate System S211 in treatment mode: Chordate System S211 in treatment mode'}, {'id': 'OG001', 'title': 'Sham Treatment', 'description': 'Chordate System S211 in placebo mode: Chordate System S211 in placebo mode'}], 'classes': [{'title': 'Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '16.2', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '14.2', 'groupId': 'OG001'}]}]}, {'title': 'Visit 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.2', 'spread': '23.5', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '19.2', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.5', 'spread': '25.2', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '24.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)', 'description': 'The emotional function dimension of the MSQ assesses the emotional impact of migraines during the past 4 weeks. It includes 3 items. Each item is scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). The scores of these items are summed and then transformed to a 0-100 scale. This means the minimum score of the emotional function dimension is 0 and the maximum score is 100 where a higher score indicates a better health status.\n\nReported is the change from Baseline in the emotional function dimension of the MSQ at the respective visit.', 'unitOfMeasure': 'change in score on a scale from Baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'assessments of individual subjects missing at some visits'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Severity (PGI-S)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Chordate System S211 in treatment mode: Chordate System S211 in treatment mode'}, {'id': 'OG001', 'title': 'Sham Treatment', 'description': 'Chordate System S211 in placebo mode: Chordate System S211 in placebo mode'}], 'classes': [{'title': 'Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Not done', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'normal', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'mild', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'moderate', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'title': 'severe', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Not done', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'normal', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'mild', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'moderate', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}, {'title': 'severe', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Not done', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'normal', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'title': 'mild', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'moderate', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'severe', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Visit 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Not done', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'normal', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}, {'title': 'mild', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'moderate', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'severe', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Not done', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'normal', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': 'mild', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'moderate', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'severe', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days -28 (screening), 0 (visit 1), 14 (Visit 3), 42 (Visit 7), 70 (Follow-up)', 'description': "The PGI-S is a 1-item questionnaire to assess the subject's impression of disease severity. The subjects rated the severity of their condition on a scale from 1 to 4: 1=normal, 2=mild, 3=moderate, 4=severe", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'assessments of individual subjects missing at some visits'}, {'type': 'SECONDARY', 'title': 'Incidence of Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment', 'description': 'Chordate System S211 in treatment mode: Chordate System S211 in treatment mode'}, {'id': 'OG001', 'title': 'Sham Treatment', 'description': 'Chordate System S211 in placebo mode: Chordate System S211 in placebo mode'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Any treatment emergent adverse event', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'any serious treatment emergent adverse event', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any treatment emergent adverse event related to medical device', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Any treatment emergent adverse event related to procedure', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 0, 7, 14, 21, 28, 35, 42, 70', 'description': 'n (%) of patients', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Treatment', 'description': 'Chordate System S211 in treatment mode: Chordate System S211 in treatment mode'}, {'id': 'FG001', 'title': 'Sham Treatment', 'description': 'Chordate System S211 in placebo mode: Chordate System S211 in placebo mode'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'Randomization', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'Safety Analysis Set (SAF)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Treatment', 'description': 'Chordate System S211 in treatment mode: Chordate System S211 in treatment mode'}, {'id': 'BG001', 'title': 'Sham Treatment', 'description': 'Chordate System S211 in placebo mode: Chordate System S211 in placebo mode'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '64'}, {'value': '46', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '67'}, {'value': '48', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '67'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}]}, {'title': 'Arabian (Jordan)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Finland', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '26.3', 'spread': '5.6', 'groupId': 'BG000'}, {'value': '25.3', 'spread': '5.0', 'groupId': 'BG001'}, {'value': '25.9', 'spread': '5.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'One subject was randomized to and treated with placebo and was assigned to the placebo group in the FAS, but received active treatment for a short time at Visit 1 and was therefore assigned to the active group in the SAF. Baseline subject demographics are based on the SAF.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-14', 'size': 716315, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-02-16T07:22', 'hasProtocol': True}, {'date': '2022-10-12', 'size': 250510, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-02-16T07:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2018-01-09', 'resultsFirstSubmitDate': '2024-02-18', 'studyFirstSubmitQcDate': '2018-01-09', 'lastUpdatePostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-14', 'studyFirstPostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline (4-week Screening Period) in Monthly Headache Days With Moderate to Severe Intensity in 4-week Performance Assessment Period.', 'timeFrame': 'Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42', 'description': 'Least square mean change from Baseline (4-week screening period) in monthly headache days with moderate to severe intensity in 4-week performance assessment period.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Monthly Headache Days With Moderate to Severe Intensity in Follow-up Period', 'timeFrame': 'Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70'}, {'measure': 'Mean Change From Baseline to Performance Assessment Period in Monthly Migraine Days', 'timeFrame': 'Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42'}, {'measure': 'Mean Change From Baseline to Follow-up Period in Monthly Migraine Days', 'timeFrame': 'Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70'}, {'measure': 'Mean Change From Baseline to Performance Assessment Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities', 'timeFrame': 'Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42'}, {'measure': 'Mean Change From Baseline to Follow-up Period in 4-week Headache Days (Mild, Moderate and Severe Intensity) - All Intensities', 'timeFrame': 'Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70'}, {'measure': 'Proportion of Subjects With 30% or Greater Reduction in Headache Days of Moderate to Severe Intensity in Performance Assessment Period', 'timeFrame': 'Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42'}, {'measure': 'Proportion of Subjects With 30% or Greater Reduction in Headache Days of Moderate to Severe Intensity in Follow-up Period', 'timeFrame': 'Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70'}, {'measure': 'Proportion of Subjects With 50% or Greater Reduction of Headache Days of Moderate to Severe Intensity in Performance Assessment Period', 'timeFrame': 'Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42'}, {'measure': 'Proportion of Subjects With 50% or Greater Reduction of Headache Days of Moderate to Severe Intensity in Follow-up Period', 'timeFrame': 'Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70'}, {'measure': 'Change in the Use of Abortive Medication in Performance Assessment Period', 'timeFrame': 'Interval from Day -28 to Day 0 and Interval from Day 14 to Day 42'}, {'measure': 'Change in the Use of Abortive Medication in Follow-up Period', 'timeFrame': 'Interval from Day -28 to Day 0 and Interval from Day 43 to Day 70'}, {'measure': 'Headache Impact Test', 'timeFrame': 'Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)', 'description': "The headache impact test-6 (HIT-6) is a 6-item self-administered questionnaire that evaluates the extent of disability a subject experiences due to headache by measuring the subject's level of pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The final total score is obtained from simple summation of the 6 items. The total score ranges between 36 and 78, with larger scores reflecting greater impact.\n\nReported is the change from Baseline in the final total score at the respective visit."}, {'measure': 'Migraine-Specific Quality of Life Questionnaire (MSQ) - Role Function - Restrictive', 'timeFrame': 'Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)', 'description': 'The role function-restrictive dimension of the MSQ assesses how migraines limit daily activities and interactions during the past 4 weeks. It includes 7 items. Each item is scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). The scores of these items are summed and then transformed to a 0-100 scale. This means the minimum score of the role function restrictive dimension is 0 and the maximum score is 100 where a higher score indicates a better health status.\n\nReported is the change from Baseline in the role function restrictive dimension of the MSQ at the respective visit.'}, {'measure': 'MSQ - Role Function - Preventive', 'timeFrame': 'Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)', 'description': 'The role function-preventive dimension of the MSQ assesses how migraines prevent from engaging in daily activities during the past 4 weeks. It includes 4 items. Each item is scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). The scores of these items are summed and then transformed to a 0-100 scale. This means the minimum score of the role function-preventive dimension is 0 and the maximum score is 100 where a higher score indicates a better health status.\n\nReported is the change from Baseline in the role function-preventive dimension of the MSQ at the respective visit.'}, {'measure': 'MSQ - Emotional Function', 'timeFrame': 'Days -28, 0, 14 (Visit 3), 42 (Visit 7), 70 (follow-up)', 'description': 'The emotional function dimension of the MSQ assesses the emotional impact of migraines during the past 4 weeks. It includes 3 items. Each item is scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). The scores of these items are summed and then transformed to a 0-100 scale. This means the minimum score of the emotional function dimension is 0 and the maximum score is 100 where a higher score indicates a better health status.\n\nReported is the change from Baseline in the emotional function dimension of the MSQ at the respective visit.'}, {'measure': 'Patient Global Impression of Severity (PGI-S)', 'timeFrame': 'Days -28 (screening), 0 (visit 1), 14 (Visit 3), 42 (Visit 7), 70 (Follow-up)', 'description': "The PGI-S is a 1-item questionnaire to assess the subject's impression of disease severity. The subjects rated the severity of their condition on a scale from 1 to 4: 1=normal, 2=mild, 3=moderate, 4=severe"}, {'measure': 'Incidence of Adverse Events (AEs)', 'timeFrame': 'Days 0, 7, 14, 21, 28, 35, 42, 70', 'description': 'n (%) of patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prophylaxis, Headache, Preventative Treatment'], 'conditions': ['Chronic Migraine']}, 'referencesModule': {'references': [{'pmid': '39787477', 'type': 'DERIVED', 'citation': 'Hoffmann J, Kaube H, Rimmele F, Jurgens TP, Nissila M, Gaul C, Kallela M, Keski-Santti P, Sumelahti ML, Straube A, Lewis D, Hoffmann V, Wirtz L, Rempel A, Bohm O, May A. Kinetic Oscillation Stimulation for the Preventive Treatment of Chronic Migraine: A Randomized, Double-Blind, Sham-Controlled Trial. Neurology. 2025 Feb 11;104(3):e210220. doi: 10.1212/WNL.0000000000210220. Epub 2025 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'The efficacy of intranasal kinetic oscillation stimulation using the Chordate System S211 as a preventative treatment will be examined in patients diagnosed with chronic migraine. The medical device system will be applied in 6 treatments at weekly intervals. The study will examine the effects on monthly headache days with moderate to severe intensity.', 'detailedDescription': 'This is a randomized, placebo-controlled, double-blind, multicenter clinical investigation of a medical device. The study consists of a 4-week screening period, a 6-week treatment period (2 weeks run-in and a 4-week observation window to assess the treatment effect), and a 4-week follow-up period.\n\nThe study primarily aims at evaluating the effect of intranasal kinetic oscillation stimulation using the Chordate System S211 as a preventative treatment on monthly headache days with moderate to severe intensity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form (ICF);\n2. Male or female aged between 18 and 65 years (inclusive) at the time of providing informed consent;\n3. Diagnosed as suffering from chronic migraine with or without aura (≥15 headache days per month for more than 3 months before screening including at least 8 migraine days) according to the IHS classification (International Classification of Headache Disorders \\[ICHD\\]-III beta);\n4. Migraine onset before the age of 60 years;\n5. Reported history of migraine for at least 1 year before screening;\n6. Reported stable prophylactic migraine medication regimen, if any, during the 3 months prior to screening;\n7. Able and willing to maintain current prophylactic migraine medication regimen (no change in type, frequency or dose) from screening to end of follow-up;\n8. Women of childbearing potential must be willing to use highly effective contraceptive methods (failure rate \\<1% per year when used consistently and correctly) during the study.\n\nExclusion Criteria:\n\n1. Unable to distinguish between migraine headaches and other headache types;\n2. Treatment with Botox in the head/neck area within 4 months of the screening visit, or planned Botox treatment during the study;\n3. Previous or ongoing treatment with an implanted stimulator or other implanted device in the head and/or neck;\n4. Known pronounced anterior septal deviation, or other known relevant abnormality in the nasal cavity, including bacterial infection and wounds;\n5. History of relevant sinus surgery, transsphenoidal surgery for pituitary or other lesions or cerebrospinal fluid (CSF) rhinorrhea;\n6. Fitted with a pacemaker/defibrillator;\n7. Previously treated with therapeutic x-ray intervention in the facial region (that could have influenced the nasal mucosa);\n8. Ongoing upper respiratory infection or malignancy in the nasal cavity;\n9. History of regular nose bleeding (epistaxis), or concomitant condition or medication that could cause excessive bleeding including treatment with an anticoagulant;\n10. Head injury or open wound that contraindicates use of the Chordate Headband;\n11. Known allergy to polyvinylchloride, a material used in the Chordate Catheter, or medicinal liquid paraffin;\n12. Concurrent condition or risk of non-compliance that, in the investigator's opinion, may affect the interpretation of performance or safety data or which otherwise contraindicates participation in a clinical investigation;\n13. Pregnant and lactating women;\n14. Participation in a clinical investigation within 3 months of enrolment or planned participation at any time during this clinical investigation;\n15. Previous participation in this study;\n16. Employees of the study site or the sponsor directly involved with the conduct of the study, or immediate family members of any such individuals."}, 'identificationModule': {'nctId': 'NCT03400059', 'briefTitle': 'Study to Evaluate the Efficacy of Intranasal Kinetic Oscillation Stimulation in the Preventive Treatment of Chronic Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chordate Medical'}, 'officialTitle': 'A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Efficacy of Intranasal Kinetic Oscillation Stimulation in the Preventive Treatment of Chronic Migraine', 'orgStudyIdInfo': {'id': 'PM007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Treatment', 'interventionNames': ['Device: Chordate System S211 in treatment mode']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Treatment', 'interventionNames': ['Device: Chordate System S211 in placebo mode']}], 'interventions': [{'name': 'Chordate System S211 in treatment mode', 'type': 'DEVICE', 'description': 'Chordate System S211 in treatment mode', 'armGroupLabels': ['Active Treatment']}, {'name': 'Chordate System S211 in placebo mode', 'type': 'DEVICE', 'description': 'Chordate System S211 in placebo mode', 'armGroupLabels': ['Sham Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00180', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Terveystalo Ruoholahti', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '00930', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsingin päänsärkykeskus / Aava Itäkeskus', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '33100', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Terveystalo Tampere', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '20100', 'city': 'Turku', 'country': 'Finland', 'facility': 'Suomen Terveystalo Turku', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '70178', 'city': 'Stuttgart', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Lewis Neurologie', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '80802', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Neurologie- & Kopfschmerzzentrum', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '81377', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinikum Großhadern / Neurologische Klinik der Universität München', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '61462', 'city': 'Königstein im Taunus', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Migräne-Klinik Königstein', 'geoPoint': {'lat': 50.17943, 'lon': 8.47132}}, {'zip': '18147', 'city': 'Rostock', 'state': 'Mecklenburg-Vorpommern', 'country': 'Germany', 'facility': 'Universitätsmedizin Rostock / Klinik und Poliklinik für Neurologie', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'zip': '20251', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'CTC North am Universitätsklinikum Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Arne May, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to uncertainties in EU data protection legislation individual deidentified participant data are not shared. The main uncertainty is the concept of what "deidentified" means. It appears not to mean that the data set of a person is simply separated from the person\'s name. What additional operations have to be done appears to depend on technological capabilities to re-identify the persons associated with the data set. A common perception is that the technological capabilities for re-identification are permanently increasing. This could have the effect that public data sets that are regarded as deidentified now might become re-identifiable data sets in the future. Once this happens, the sponsor is no longer able to make the publication of the data sets un-happen. This could result in punishment by EU data protection authorities. The sponsor wants to avoid this.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chordate Medical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Vinnova', 'class': 'OTHER_GOV'}, {'name': 'FGK Clinical Research GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}