Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-03-27 @ 4:49 AM
Study NCT ID:
NCT02342704
Status:
TERMINATED
Last Update Posted:
2017-06-09
First Post:
2015-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark']}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069442', 'term': 'Natalizumab'}, {'id': 'D000068876', 'term': 'Fingolimod Hydrochloride'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D013110', 'term': 'Sphingosine'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011409', 'term': 'Propylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@biogen.com', 'title': 'Biogen Study Medical Director', 'organization': 'Biogen'}, 'certainAgreement': {'otherDetails': "Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 64 weeks.', 'description': 'Treatment-emergent adverse events are presented.', 'eventGroups': [{'id': 'EG000', 'title': 'Natalizumab', 'description': 'Open-label natalizumab 300 mg IV every 4 weeks', 'otherNumAtRisk': 54, 'otherNumAffected': 14, 'seriousNumAtRisk': 54, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fingolimod', 'description': 'Open-label fingolimod 0.5 mg once daily orally', 'otherNumAtRisk': 54, 'otherNumAffected': 23, 'seriousNumAtRisk': 54, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Migraine with aura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cumulative Number of ≥ 6-Month Confirmed T1-Hypointense Lesions Arising From New On-Treatment T1-Gadolinium-Enhancing (Gd+) Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Natalizumab', 'description': 'Open-label natalizumab 300 mg IV every 4 weeks'}, {'id': 'OG001', 'title': 'Fingolimod', 'description': 'Open-label fingolimod 0.5 mg once daily orally'}], 'timeFrame': 'Up to Week 52', 'reportingStatus': 'POSTED', 'populationDescription': 'The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.'}, {'type': 'SECONDARY', 'title': 'Cumulative Number of New T1-Gd+ Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Natalizumab', 'description': 'Open-label natalizumab 300 mg IV every 4 weeks'}, {'id': 'OG001', 'title': 'Fingolimod', 'description': 'Open-label fingolimod 0.5 mg once daily orally'}], 'classes': [{'title': 'From Baseline to Week 4', 'categories': [{'measurements': [{'value': '0.62', 'spread': '1.512', 'groupId': 'OG000'}, {'value': '1.69', 'spread': '4.122', 'groupId': 'OG001'}]}]}, {'title': 'From Baseline to Week 12', 'categories': [{'measurements': [{'value': '0.68', 'spread': '1.695', 'groupId': 'OG000'}, {'value': '2.27', 'spread': '4.499', 'groupId': 'OG001'}]}]}, {'title': 'From Baseline to Week 24', 'categories': [{'measurements': [{'value': '0.72', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '4.745', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1260', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Week 4', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value is based on Wilcoxon rank-sum test between the 2 treatment groups'}, {'pValue': '0.3525', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Week 4', 'statisticalMethod': 'negative binomial regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value is based on negative binomial regression model, adjusted for baseline GD lesion count'}, {'pValue': '0.0127', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Week 12', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value is based on Wilcoxon rank-sum test between the 2 treatment groups'}, {'pValue': '0.0299', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Week 12', 'statisticalMethod': 'negative binomial regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value is based on negative binomial regression model, adjusted for baseline GD lesion count'}, {'pValue': '0.0123', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Week 24', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value is based on Wilcoxon rank-sum test between the 2 treatment groups'}, {'pValue': '0.0076', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Week 24', 'statisticalMethod': 'negative binomial regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value is based on negative binomial regression model, adjusted for baseline GD lesion count'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, Week 12, Week 24', 'unitOfMeasure': 'lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total T1-Hypointense and Total T2-Hyperintense Lesion Volumes at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Natalizumab', 'description': 'Open-label natalizumab 300 mg IV every 4 weeks'}, {'id': 'OG001', 'title': 'Fingolimod', 'description': 'Open-label fingolimod 0.5 mg once daily orally'}], 'classes': [{'title': 'T1 Lesion Volume Change', 'categories': [{'measurements': [{'value': '0.5', 'spread': '31.235', 'groupId': 'OG000'}, {'value': '1.81', 'spread': '19.703', 'groupId': 'OG001'}]}]}, {'title': 'T2 Lesion Volume Change', 'categories': [{'measurements': [{'value': '0.08', 'spread': '4.399', 'groupId': 'OG000'}, {'value': '3.32', 'spread': '5.036', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5318', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'T1 Lesion Volume Change', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value is based on Wilcoxon rank-sum test between the 2 treatment groups'}, {'pValue': '0.0528', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'T2 Lesion Volume Change', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value is based on Wilcoxon rank-sum test between the 2 treatment groups'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'As assessed by magnetic resonance imaging (MRI).', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and had an assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total T1-Hypointense and Total T2-Hyperintense Lesion Volumes at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Natalizumab', 'description': 'Open-label natalizumab 300 mg IV every 4 weeks'}, {'id': 'OG001', 'title': 'Fingolimod', 'description': 'Open-label fingolimod 0.5 mg once daily orally'}], 'classes': [{'title': 'T1 Lesion Volume Change', 'categories': [{'measurements': [{'value': '-15.31', 'spread': 'NA', 'comment': 'only 1 participant had an assessment', 'groupId': 'OG001'}]}]}, {'title': 'T2 Lesion Volume Change', 'categories': [{'measurements': [{'value': '5.6', 'spread': 'NA', 'comment': 'only 1 participant had an assessment', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'As assessed by MRI.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and had an assessment.'}, {'type': 'SECONDARY', 'title': 'Cumulative Number of New or Enlarging T2 Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Natalizumab', 'description': 'Open-label natalizumab 300 mg IV every 4 weeks'}, {'id': 'OG001', 'title': 'Fingolimod', 'description': 'Open-label fingolimod 0.5 mg once daily orally'}], 'classes': [{'categories': [{'measurements': [{'value': '1.33', 'spread': '2.469', 'groupId': 'OG000'}, {'value': '1.94', 'spread': '2.205', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2632', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'p-value is based on Wilcoxon rank-sum test between the 2 treatment groups'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'unitOfMeasure': 'lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and had an assessment.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With No Evidence of Disease Activity (NEDA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Natalizumab', 'description': 'Open-label natalizumab 300 mg IV every 4 weeks'}, {'id': 'OG001', 'title': 'Fingolimod', 'description': 'Open-label fingolimod 0.5 mg once daily orally'}], 'timeFrame': 'Up to Week 52', 'description': 'NEDA was defined as all of the following: no relapses; no 12-week confirmed disability progression based on Expanded Disability Status Scale (EDSS; defined as an increase of 1.0 or more on the EDSS from baseline of 1.0 or more, or an increase of 1.5 or more from a baseline score of 0) that was sustained for 12 weeks; no new T1-Gd+ lesions on brain MRI. No new or enlarging T2-hyperintense lesions.', 'reportingStatus': 'POSTED', 'populationDescription': 'The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.'}, {'type': 'SECONDARY', 'title': 'Time to First Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Natalizumab', 'description': 'Open-label natalizumab 300 mg IV every 4 weeks'}, {'id': 'OG001', 'title': 'Fingolimod', 'description': 'Open-label fingolimod 0.5 mg once daily orally'}], 'timeFrame': 'Up to Week 52', 'description': 'A clinical relapse was defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement.', 'reportingStatus': 'POSTED', 'populationDescription': 'The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.'}, {'type': 'SECONDARY', 'title': 'Cumulative Risk of Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Natalizumab', 'description': 'Open-label natalizumab 300 mg IV every 4 weeks'}, {'id': 'OG001', 'title': 'Fingolimod', 'description': 'Open-label fingolimod 0.5 mg once daily orally'}], 'timeFrame': 'Up to Week 52', 'description': 'A clinical relapse was defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement.', 'reportingStatus': 'POSTED', 'populationDescription': 'The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.'}, {'type': 'SECONDARY', 'title': 'Time to Complete Recovery From First Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Natalizumab', 'description': 'Open-label natalizumab 300 mg IV every 4 weeks'}, {'id': 'OG001', 'title': 'Fingolimod', 'description': 'Open-label fingolimod 0.5 mg once daily orally'}], 'timeFrame': 'Up to Week 52', 'description': '12-week confirmed complete EDSS recovery from first on-treatment relapse is defined as an EDSS score that is equal to or lower than the last pre-relapse EDSS score and sustained for at least 12 weeks.', 'reportingStatus': 'POSTED', 'populationDescription': 'The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Symbol Digit Modalities Test (SDMT) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Natalizumab', 'description': 'Open-label natalizumab 300 mg IV every 4 weeks'}, {'id': 'OG001', 'title': 'Fingolimod', 'description': 'Open-label fingolimod 0.5 mg once daily orally'}], 'classes': [{'categories': [{'measurements': [{'value': '3.79', 'spread': '8.684', 'groupId': 'OG000'}, {'value': '3.24', 'spread': '4.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and had both baseline and post-baseline values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SDMT at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Natalizumab', 'description': 'Open-label natalizumab 300 mg IV every 4 weeks'}, {'id': 'OG001', 'title': 'Fingolimod', 'description': 'Open-label fingolimod 0.5 mg once daily orally'}], 'classes': [{'categories': [{'measurements': [{'value': '2.11', 'spread': '8.492', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and had both baseline and post-baseline values.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Natalizumab', 'description': 'Open-label natalizumab 300 mg IV every 4 weeks'}, {'id': 'FG001', 'title': 'Fingolimod', 'description': 'Open-label fingolimod 0.5 mg once daily orally'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Safety Population: randomized participants who received at least 1 dose of study treatment.', 'groupId': 'FG000', 'numSubjects': '54'}, {'comment': 'Safety Population: randomized participants who received at least 1 dose of study treatment.', 'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '51'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Sponsor Termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'A total of 128 participants were screened, 111 participants were enrolled in the study. Three participants were not randomized and did not receive any dose of study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Natalizumab', 'description': 'Open-label natalizumab 300 mg IV every 4 weeks'}, {'id': 'BG001', 'title': 'Fingolimod', 'description': 'Open-label fingolimod 0.5 mg once daily orally'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.19', 'spread': '8.811', 'groupId': 'BG000'}, {'value': '34.87', 'spread': '8.731', 'groupId': 'BG001'}, {'value': '36.53', 'spread': '8.887', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'whyStopped': 'Business Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-17', 'studyFirstSubmitDate': '2015-01-15', 'resultsFirstSubmitDate': '2017-05-17', 'studyFirstSubmitQcDate': '2015-01-15', 'lastUpdatePostDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-17', 'studyFirstPostDateStruct': {'date': '2015-01-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative Number of ≥ 6-Month Confirmed T1-Hypointense Lesions Arising From New On-Treatment T1-Gadolinium-Enhancing (Gd+) Lesions', 'timeFrame': 'Up to Week 52'}], 'secondaryOutcomes': [{'measure': 'Cumulative Number of New T1-Gd+ Lesions', 'timeFrame': 'Baseline, Week 4, Week 12, Week 24'}, {'measure': 'Change From Baseline in Total T1-Hypointense and Total T2-Hyperintense Lesion Volumes at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'As assessed by magnetic resonance imaging (MRI).'}, {'measure': 'Change From Baseline in Total T1-Hypointense and Total T2-Hyperintense Lesion Volumes at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'As assessed by MRI.'}, {'measure': 'Cumulative Number of New or Enlarging T2 Lesions', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Proportion of Participants With No Evidence of Disease Activity (NEDA)', 'timeFrame': 'Up to Week 52', 'description': 'NEDA was defined as all of the following: no relapses; no 12-week confirmed disability progression based on Expanded Disability Status Scale (EDSS; defined as an increase of 1.0 or more on the EDSS from baseline of 1.0 or more, or an increase of 1.5 or more from a baseline score of 0) that was sustained for 12 weeks; no new T1-Gd+ lesions on brain MRI. No new or enlarging T2-hyperintense lesions.'}, {'measure': 'Time to First Relapse', 'timeFrame': 'Up to Week 52', 'description': 'A clinical relapse was defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement.'}, {'measure': 'Cumulative Risk of Relapse', 'timeFrame': 'Up to Week 52', 'description': 'A clinical relapse was defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement.'}, {'measure': 'Time to Complete Recovery From First Relapse', 'timeFrame': 'Up to Week 52', 'description': '12-week confirmed complete EDSS recovery from first on-treatment relapse is defined as an EDSS score that is equal to or lower than the last pre-relapse EDSS score and sustained for at least 12 weeks.'}, {'measure': 'Change From Baseline in Symbol Digit Modalities Test (SDMT) at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.'}, {'measure': 'Change From Baseline in SDMT at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.'}]}, 'conditionsModule': {'conditions': ['Relapsing-Remitting Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '33082194', 'type': 'DERIVED', 'citation': 'Butzkueven H, Licata S, Jeffery D, Arnold DL, Filippi M, Geurts JJ, Santra S, Campbell N, Ho PR; REVEAL Investigators. Natalizumab versus fingolimod for patients with active relapsing-remitting multiple sclerosis: results from REVEAL, a prospective, randomised head-to-head study. BMJ Open. 2020 Oct 20;10(10):e038861. doi: 10.1136/bmjopen-2020-038861.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess the effect of natalizumab compared to fingolimod on the evolution of new on-treatment T1-gadolinium-enhancing (Gd+) lesions to persistent black holes (PBH) over 52 weeks. The secondary objectives of this study in this study population are to assess the effect of natalizumab compared to fingolimod on: magnetic resonance imaging (MRI) measures of central nervous system (CNS) tissue destruction as measured by the number of new T1-Gd+ lesions; various other MRI measures of disease activity; No Evidence of Disease Activity (NEDA); Relapse on treatment over 52 weeks; The change in information processing speed as measured by the Symbol Digit Modalities Test (SDMT).', 'detailedDescription': 'This study also includes a Diffusion Tensor Imaging (DTI) sub-study that includes healthy volunteers. Healthy volunteers will not receive any study medication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria for MS Patients:\n\n* Must have a documented diagnosis of relapsing MS (McDonald 2010 Criteria) at study screening with EDSS score from 0.0 to 5.5.\n* If the subject is on Betaseron, Rebif, Avonex, Copaxone, Extavia, Tecfidera, and Aubagio (BRACE-TA) at study screening:\n* He/she must have been on therapy for at least 6 months (unless experiencing highly active disease), have at least 9 T2-hyperintense lesions on a brain MRI scan, and have experienced ≥1 relapse within the last 6 months prior to study screening with ≥1 new T1-Gd+ lesion on a brain MRI scan performed ≤6 months prior to study screening or ≥2 new T2 lesions on a brain MRI scan performed ≤6 months prior to study screening, with comparison made to a T2 MRI scan performed up to 18 months before study screening\n* If the subject has highly active disease, regardless of whether they are disease-modifying therapy (DMT)-naïve or had previous exposure to Betaseron, Rebif, Avonex, Copaxone, Extavia, Tecfidera, and Aubagio (BRACE-TA), they must have had ≥2 disabling relapses in the 12 months prior to study screening and either ≥1 new T1-Gd+ lesion on a brain MRI scan performed ≤6 months prior to study screening or ≥2 new T2 lesions on a brain MRI scan performed ≤6 months prior to study screening, with comparison made to a T2 MRI scan performed up to 18 months before study screening\n\nKey Exclusion Criteria for MS Patients:\n\n* Diagnosis of Primary Progressive Multiple Sclerosis and/or Secondary Progressive Multiple Sclerosis.\n* History or positive test result at study screening for human immunodeficiency virus (HIV), hepatitis C virus (HCV) antibody or current hepatitis B infection (defined as positive for hepatitis B surface antigen \\[HBsAg\\] and/or hepatitis B core antibody \\[HBcAb\\]).\n* Prior treatment with natalizumab or fingolimod.\n* History of or known active malignant disease, including solid tumors and hematologic malignancies (subjects with cutaneous basal and squamous cell carcinoma that has been completely excised and considered cured prior to study screening remain eligible).\n* History of opportunistic infections or any clinically significant major disease, as determined by the Investigator.\n* A clinically significant infectious illness (e.g., pneumonia, septicemia) within the 1 month prior to study screening.\n* History of drug or alcohol abuse (as defined by the Investigator) within 1 year prior to study screening.\n* Prior history of immunosuppressant use (e.g., mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate, cladribine, rituximab), or exposure to intravenous immunoglobulin (IGIV), monoclonal antibodies, cytokines, growth factors, soluble receptors, other recombinant products, or fusion proteins in the last 12 months prior to study screening.\n* History of myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure in last 6 months.\n* Treatment with Class Ia (e.g., procainamide, quinidine, ajmaline, disopyramide) or Class III (amiodarone, bretylium, dofelitide, sotalol, ibulitide, azilimide) anti-arrhythmic drugs.\n* Concurrent therapy with drugs that slow heart rate (e.g., beta-blockers, heart-rate lowering calcium channel blockers such as diltiazem or verapamil, or digoxin).\n* Hypertension not controlled with prescribed medications.\n* History of severe respiratory disease, pulmonary fibrosis or class III or IV chronic obstructive pulmonary disease.\n* The use of live or live attenuated vaccination within 8 weeks of study screening.\n\nKey Inclusion Criteria for Healthy Volunteers:\n\n* Subjects who are generally healthy as demonstrated by physical examination and by medical history, with no history or evidence of major illnesses, diseases, or disorders.\n* Subjects of childbearing potential must practice effective contraception and be willing and able to continue contraception for duration of the study.\n* No history of drug or alcohol abuse (as defined by the Investigator) within 1 year prior to study screening.\n\nKey Exclusion Criteria for Healthy Volunteers:\n\n* Claustrophobia sufficient to interfere with generating reliable MRI scans.\n* History of other major illness including neurological disorders as determined by the Investigator.\n* Presence of a metal device affected by MRI (e.g., any type of electronic, mechanical or magnetic implant, cardiac pacemaker, aneurysm clips, implanted cardiac defibrillator) or potential ferromagnetic foreign body (metal slivers, metal shavings, other metal objects), which would be a contraindication for MRI.\n* Women who are currently pregnant or breastfeeding, or who have a positive pregnancy test result at screening.\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT02342704', 'acronym': 'REVEAL', 'briefTitle': 'Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab Versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects', 'orgStudyIdInfo': {'id': '101MS408'}, 'secondaryIdInfos': [{'id': '2013-004622-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'natalizumab', 'description': 'Open-label natalizumab 300 mg IV every 4 weeks (Q4W)', 'interventionNames': ['Drug: natalizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'fingolimod', 'description': 'Open-label fingolimod 0.5 mg once daily orally', 'interventionNames': ['Drug: fingolimod']}], 'interventions': 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