Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-03-01 @ 1:45 PM
Study NCT ID:
NCT03110458
Status:
COMPLETED
Last Update Posted:
2020-10-27
First Post:
2017-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C000654667', 'term': 'seliforant'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'contact@sensorion-pharma.com', 'phone': '+33 4 67 20 77 30', 'title': 'Director of Regulatory Affairs', 'organization': 'Sensorion'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'up to end of study 28 days', 'description': '104 subjects overall received any treatment and were included in the safety population (SENS-111 100 mg: 36 subjects,SENS-111 200 mg: 36 subjects and placebo: 32 subjects).\n\nTreatment emergent adverse events are displayed.', 'eventGroups': [{'id': 'EG000', 'title': 'SENS-111 100mg', 'description': 'SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)\n\nSENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 4, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SENS-111 200mg', 'description': 'SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)\n\nSENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 5, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo: 2 placebo Oral Dispersible Tablets\n\nPlacebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 7, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Extra dose administered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Folate deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Diverticular perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Standing Vertigo Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SENS-111 100mg', 'description': 'SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)\n\nSENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.'}, {'id': 'OG001', 'title': 'SENS-111 200mg', 'description': 'SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)\n\nSENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: 2 placebo Oral Dispersible Tablets\n\nPlacebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.'}], 'classes': [{'categories': [{'measurements': [{'value': '165.10', 'spread': '71.02', 'groupId': 'OG000'}, {'value': '155.10', 'spread': '83.06', 'groupId': 'OG001'}, {'value': '136.60', 'spread': '62.61', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.8466', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'over the 4 treatment days', 'description': 'The primary efficacy endpoint was the Area Under Curve (AUC) for the vertigo intensity measured by the Vertigo Intensity Visual Analogue Scale (VI-VAS) in standing position over the 4 treatment days (8 post-baseline assessments).\n\nThe vertigo Intensity VAS is a non-anchored 10cm horizontal line. Patients were asked to rate the intensity of their vertigo making a vertical mark crossing the horizontal 10 cm line to indicate the severity from 0-100 when 0 indicates no severity and 100 indicates worse severity.', 'unitOfMeasure': 'mm*day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Among the patients who started the study data was missing for some patients: 3 SENS-111 100mg, 1 SENS-111 200mg, 3 placebo patients'}, {'type': 'SECONDARY', 'title': 'Worst Spontaneous Vertigo Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SENS-111 100mg', 'description': 'SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)\n\nSENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.'}, {'id': 'OG001', 'title': 'SENS-111 200mg', 'description': 'SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)\n\nSENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: 2 placebo Oral Dispersible Tablets\n\nPlacebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.'}], 'classes': [{'categories': [{'measurements': [{'value': '180.10', 'spread': '67.20', 'groupId': 'OG000'}, {'value': '170.40', 'spread': '89.83', 'groupId': 'OG001'}, {'value': '140.8', 'spread': '64.66', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.9538', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'over the 4 treatment days', 'description': 'Worst spontaneous vertigo intensity measured by the AUC of the worst Vertigo Intensity Visual Analogue Scale (VI-VAS) over the 4 treatment days (8 post-baseline assessments).\n\nThe vertigo Intensity VAS is a non-anchored 10cm horizontal line. Patients were asked to rate the intensity of their vertigo making a vertical mark crossing the horizontal 10 cm line to indicate the severity from 0-100 when 0 indicates no severity and 100 indicates worse severity', 'unitOfMeasure': 'mm*day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Among the patients who started the study data was missing for some patients: 6 SENS-111 100mg, 4 SENS-111 200mg, 7 placebo'}, {'type': 'SECONDARY', 'title': 'Proprioception D5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SENS-111 100mg', 'description': 'SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)\n\nSENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.'}, {'id': 'OG001', 'title': 'SENS-111 200mg', 'description': 'SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)\n\nSENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: 2 placebo Oral Dispersible Tablets\n\nPlacebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.10', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '2.00', 'spread': '1.79', 'groupId': 'OG001'}, {'value': '2.40', 'spread': '1.45', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3166', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'End of treatment Day 5', 'description': "The Romberg test assess the patient's ability to stand unassisted under 6 successive test conditions of increasing difficulty. In this test higher values are indicating a higher ability to stand unassisted, minimum total score is : 0 (impossibility to stand unassisted in any of the six conditions) and maximum is: 6. The change from Baseline of the total score of the six conditions of the Romberg test at the end of treatment (EOT) (Day 5) is evaluated.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Among the patients who started the study data was missing for some patients: 5 SENS-111 100mg, 4 SENS-111 200mg, 8 placebo patients'}, {'type': 'SECONDARY', 'title': 'Proprioception D28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SENS-111 100mg', 'description': 'SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)\n\nSENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.'}, {'id': 'OG001', 'title': 'SENS-111 200mg', 'description': 'SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)\n\nSENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: 2 placebo Oral Dispersible Tablets\n\nPlacebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.70', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '3.00', 'spread': '1.64', 'groupId': 'OG001'}, {'value': '3.20', 'spread': '1.46', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.393', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'End of study Day 28', 'description': "The Romberg test assess the patient's ability to stand unassisted under 6 successive test conditions of increasing difficulty. In this test higher values are indicating a higher ability to stand unassisted, minimum total score is : 0 (impossibility to stand unassisted in any of the six conditions) and maximum is: 6. Change from Baseline of the total score of the six conditions of the Romberg test at the end of study (EOS) (Day 28) is evaluated.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Among the patients who started the study data was missing for some patients: 7 SENS-111 100mg, 3 SENS-111 200mg, 8 placebo patients'}, {'type': 'SECONDARY', 'title': 'Vestibular Spontaneous Nystagmus D5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SENS-111 100mg', 'description': 'SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)\n\nSENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.'}, {'id': 'OG001', 'title': 'SENS-111 200mg', 'description': 'SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)\n\nSENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: 2 placebo Oral Dispersible Tablets\n\nPlacebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.'}], 'classes': [{'title': 'with fixation (10 seconds)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.30', 'spread': '11.64', 'groupId': 'OG000'}, {'value': '-3.50', 'spread': '10.27', 'groupId': 'OG001'}, {'value': '-5.7', 'spread': '8.15', 'groupId': 'OG002'}]}]}, {'title': 'without fixation (30 seconds)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '5.77', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '7.22', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '5.22', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of treatment Day 5 compared to basleine', 'description': 'Change from Baseline of the Peak Slow Phase Velocity of the Peripheral Vestibular Spontaneous Nystagmus at the end of treatment (EOT) (Day 5). It is intended to record eye movements resulting from Nystagmus, measured by Oculography performed in complete darkness with visual fixation (10 seconds) or without fixation (30 seconds).', 'unitOfMeasure': 'degrees per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Among the patients who started the study data was missing for some patients: with fixation 13 SENS-111 100mg, 10 SENS-111 200mg, 11 placebo patients; without fixation 13 SENS-111 100mg, 13 SENS-111 200mg, 13 placebo patients'}, {'type': 'SECONDARY', 'title': 'Vestibular Spontaneous Nystagmus D28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SENS-111 100mg', 'description': 'SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)\n\nSENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.'}, {'id': 'OG001', 'title': 'SENS-111 200mg', 'description': 'SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)\n\nSENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: 2 placebo Oral Dispersible Tablets\n\nPlacebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.'}], 'classes': [{'title': 'with fixation (10 seconds)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.80', 'spread': '15.10', 'groupId': 'OG000'}, {'value': '-7.9', 'spread': '12.76', 'groupId': 'OG001'}, {'value': '-7.7', 'spread': '11.59', 'groupId': 'OG002'}]}]}, {'title': 'without fixation (30 seconds)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '8.84', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '8.96', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '6.50', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days compared to baseline', 'description': 'Change from Baseline of the Peak Slow Phase Velocity of the Peripheral Vestibular Spontaneous Nystagmus at End of Study (Day 28). It is intended to record eye movements resulting from Nystagmus, measured by Oculography performed in complete darkness with visual fixation (10 seconds) or without fixation (30 seconds).', 'unitOfMeasure': 'degrees per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Among the patients who started the study data was missing for some patients: with fixation 11 SENS-111 100mg, 10 SENS-111 200mg, 12 placebo patients ; without fixation 12 SENS-111 100mg, 12 SENS-111 200mg, 13 placebo patients'}, {'type': 'SECONDARY', 'title': 'Nausea Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SENS-111 100mg', 'description': 'SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)\n\nSENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.'}, {'id': 'OG001', 'title': 'SENS-111 200mg', 'description': 'SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)\n\nSENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: 2 placebo Oral Dispersible Tablets\n\nPlacebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.00', 'spread': '78.39', 'groupId': 'OG000'}, {'value': '91.50', 'spread': '79.73', 'groupId': 'OG001'}, {'value': '92.60', 'spread': '57.28', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.5324', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'over the 4 Treatment Days (Day 5)', 'description': 'Nausea Severity measured by the Area under the Curve of the Nausea Intensity Visual Analogue Scale (NI-VAS).\n\nPatients were asked to rate the intensity of their nausea making a vertical mark crossing the horizontal 10 cm line to indicate the severity from 0-100 when 0 indicates no severity and 100 indicates worse severity.', 'unitOfMeasure': 'mm*day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Among the patients who started the study data was missing for some patients: 3 SENS-111 100mg, 1 SENS-111 200mg, 3 placebo patients'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SENS-111 100mg', 'description': 'SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)\n\nSENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.'}, {'id': 'FG001', 'title': 'SENS-111 200mg', 'description': 'SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)\n\nSENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo: 2 placebo Oral Dispersible Tablets\n\nPlacebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'SENS-111 100mg', 'description': 'SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)\n\nSENS-111 100mg: SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.'}, {'id': 'BG001', 'title': 'SENS-111 200mg', 'description': 'SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)\n\nSENS-111 200mg: SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo: 2 placebo Oral Dispersible Tablets\n\nPlacebo Oral Tablet: Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.4', 'spread': '12.89', 'groupId': 'BG000'}, {'value': '51.6', 'spread': '14.14', 'groupId': 'BG001'}, {'value': '51.1', 'spread': '2.82', 'groupId': 'BG002'}, {'value': '50.7', 'spread': '13.21', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '82.2', 'spread': '22.10', 'groupId': 'BG000'}, {'value': '81.6', 'spread': '18.9', 'groupId': 'BG001'}, {'value': '80.1', 'spread': '16.37', 'groupId': 'BG002'}, {'value': '81.3', 'spread': '18.94', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-12', 'size': 675636, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-07-20T12:22', 'hasProtocol': False}, {'date': '2017-02-09', 'size': 2107820, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-07-21T08:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-02', 'studyFirstSubmitDate': '2017-03-27', 'resultsFirstSubmitDate': '2020-07-27', 'studyFirstSubmitQcDate': '2017-04-06', 'lastUpdatePostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-02', 'studyFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standing Vertigo Intensity', 'timeFrame': 'over the 4 treatment days', 'description': 'The primary efficacy endpoint was the Area Under Curve (AUC) for the vertigo intensity measured by the Vertigo Intensity Visual Analogue Scale (VI-VAS) in standing position over the 4 treatment days (8 post-baseline assessments).\n\nThe vertigo Intensity VAS is a non-anchored 10cm horizontal line. Patients were asked to rate the intensity of their vertigo making a vertical mark crossing the horizontal 10 cm line to indicate the severity from 0-100 when 0 indicates no severity and 100 indicates worse severity.'}], 'secondaryOutcomes': [{'measure': 'Worst Spontaneous Vertigo Intensity', 'timeFrame': 'over the 4 treatment days', 'description': 'Worst spontaneous vertigo intensity measured by the AUC of the worst Vertigo Intensity Visual Analogue Scale (VI-VAS) over the 4 treatment days (8 post-baseline assessments).\n\nThe vertigo Intensity VAS is a non-anchored 10cm horizontal line. Patients were asked to rate the intensity of their vertigo making a vertical mark crossing the horizontal 10 cm line to indicate the severity from 0-100 when 0 indicates no severity and 100 indicates worse severity'}, {'measure': 'Proprioception D5', 'timeFrame': 'End of treatment Day 5', 'description': "The Romberg test assess the patient's ability to stand unassisted under 6 successive test conditions of increasing difficulty. In this test higher values are indicating a higher ability to stand unassisted, minimum total score is : 0 (impossibility to stand unassisted in any of the six conditions) and maximum is: 6. The change from Baseline of the total score of the six conditions of the Romberg test at the end of treatment (EOT) (Day 5) is evaluated."}, {'measure': 'Proprioception D28', 'timeFrame': 'End of study Day 28', 'description': "The Romberg test assess the patient's ability to stand unassisted under 6 successive test conditions of increasing difficulty. In this test higher values are indicating a higher ability to stand unassisted, minimum total score is : 0 (impossibility to stand unassisted in any of the six conditions) and maximum is: 6. Change from Baseline of the total score of the six conditions of the Romberg test at the end of study (EOS) (Day 28) is evaluated."}, {'measure': 'Vestibular Spontaneous Nystagmus D5', 'timeFrame': 'End of treatment Day 5 compared to basleine', 'description': 'Change from Baseline of the Peak Slow Phase Velocity of the Peripheral Vestibular Spontaneous Nystagmus at the end of treatment (EOT) (Day 5). It is intended to record eye movements resulting from Nystagmus, measured by Oculography performed in complete darkness with visual fixation (10 seconds) or without fixation (30 seconds).'}, {'measure': 'Vestibular Spontaneous Nystagmus D28', 'timeFrame': '28 days compared to baseline', 'description': 'Change from Baseline of the Peak Slow Phase Velocity of the Peripheral Vestibular Spontaneous Nystagmus at End of Study (Day 28). It is intended to record eye movements resulting from Nystagmus, measured by Oculography performed in complete darkness with visual fixation (10 seconds) or without fixation (30 seconds).'}, {'measure': 'Nausea Severity', 'timeFrame': 'over the 4 Treatment Days (Day 5)', 'description': 'Nausea Severity measured by the Area under the Curve of the Nausea Intensity Visual Analogue Scale (NI-VAS).\n\nPatients were asked to rate the intensity of their nausea making a vertical mark crossing the horizontal 10 cm line to indicate the severity from 0-100 when 0 indicates no severity and 100 indicates worse severity.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute unilateral vestibulopathy, AUV'], 'conditions': ['Acute Unilateral Vestibulopathy (AUV)']}, 'descriptionModule': {'briefSummary': 'A multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 2 dose-regimens of orally administered SENS-111 (100mg and 200mg) given during 4 days in patients suffering from Acute Unilateral Vestibulopathy (AUV)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria includes, but is not limited to:\n\n\\* Subject has a diagnosis of definite Acute Unilateral Vestibulopathy\n\nExclusion criteria includes, but is not limited to:\n\n* Acute continuous vertigo lasting more than 72 hours prior to randomization\n* History of acute or chronic vestibular diseases\n* History of prior acute central vestibular lesion\n* Acute or chronic disease of middle ear'}, 'identificationModule': {'nctId': 'NCT03110458', 'briefTitle': 'Efficacy of SENS-111 in Patients Suffering From Acute Unilateral Vestibulopathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sensorion'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 2 Dose Regimens of Orally Administered SENS-111 (100 mg and 200 mg) Given During 4 Days in Patients Suffering From Acute Unilateral Vestibulopathy', 'orgStudyIdInfo': {'id': 'SENS 111-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SENS-111 100mg', 'description': 'SENS-111 100mg: 2 Oral Dispersible Tablets (1 SENS-111 100 mg and 1 placebo)', 'interventionNames': ['Drug: SENS-111 100mg']}, {'type': 'EXPERIMENTAL', 'label': 'SENS-111 200mg', 'description': 'SENS-111 200mg: 2 Oral Dispersible Tablets (SENS-111 100 mg)', 'interventionNames': ['Drug: SENS-111 200mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo: 2 placebo Oral Dispersible Tablets', 'interventionNames': ['Drug: Placebo Oral Tablet']}], 'interventions': [{'name': 'SENS-111 100mg', 'type': 'DRUG', 'description': 'SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.', 'armGroupLabels': ['SENS-111 100mg']}, {'name': 'SENS-111 200mg', 'type': 'DRUG', 'description': 'SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.', 'armGroupLabels': ['SENS-111 200mg']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'description': 'Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '50005', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'University Hospital Hradec Králové', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU Gui de Chauliac', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Lariboisière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '84503', 'city': 'Altötting', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Kreiskliniken Altötting', 'geoPoint': {'lat': 48.22533, 'lon': 12.67665}}, {'zip': '12683', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Klinikum Unfallkrankenhaus Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '23538', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig-Holstein Ratzeburger', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '81377', 'city': 'Munich', 'country': 'Germany', 'facility': 'Klinikum der Universität München', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '1106', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Bajcsy-Zsilinszky Kórház és Rendelőintézet', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '7621', 'city': 'Pécs', 'country': 'Hungary', 'facility': 'Pécsi Tudományegyetem, ÁOK Klinikai Központ', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '6725', 'city': 'Szeged', 'country': 'Hungary', 'facility': 'Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '84101', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '38100', 'city': 'Hadera', 'country': 'Israel', 'facility': 'Hillel Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}, {'zip': '3109601', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Health Care Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '3436212', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Carmel Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '4428164', 'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'zip': '4941492', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale San Raffaele IRCCS', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '61469', 'city': 'Donggu', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 37.866, 'lon': 127.34942}}, {'zip': '13620', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '35015', 'city': 'Junggu', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 37.69175, 'lon': 126.60024}}, {'zip': '02559', 'city': 'Seoul', 'country': 'South Korea', 'facility': "St. Paul's Hospital, The Catholic University of Korea", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06273', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Michael STRUPP, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Munich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sensorion', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}