Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-03-13 @ 1:27 PM
Study NCT ID:
NCT02910102
Status:
COMPLETED
Last Update Posted:
2020-04-28
First Post:
2016-09-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D020961', 'term': 'Lewy Body Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C548140', 'term': '3-benzenesulfonyl-8-piperazin-1-ylquinoline'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@axovant.com', 'phone': '1-833-296-8268', 'title': 'Director, Clinical Development', 'organization': 'Axovant Sciences, Inc.'}, 'certainAgreement': {'otherDetails': 'All proposed manuscripts, publications or abstracts must be reviewed and approved by the Sponsor 60 days prior to submission for publication. All confidential information identified by the Sponsor must be deleted prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Screening through post-treatment (Up to 16 Weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'RVT-101 35 mg', 'description': 'Subjects who dosed with RVT-101 in both sequences (AB and BA) are included', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Subjects who dosed with Placebo in both sequences (AB and BA) are included', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Screening Period', 'description': 'Participants screened (0-4 weeks) prior to entering to the first dose of single-blind study medication (ie, prior to the Run-In period)', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 0, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Run-In Period', 'description': 'Placebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet (for 2 weeks)', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'RVT-101 Post-Treatment', 'description': 'Subjects reported adverse events after completing the treatment period. The Post-Treatment period - defined as up to 17 days post-last-dose', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Placebo Post-Treatment', 'description': 'Subjects reported adverse events after completing the treatment period. The Post-Treatment period - defined as up to 17 days post-last-dose', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Gait Speed (cm/Sec) Measurements From Baseline to the End of Each Double-blind Treatment Period Based on Computerized Gait Assessment Tools.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RVT-101 35 mg', 'description': 'Subjects who dosed with RVT-101 in both sequences (AB and BA) are included in this analysis'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects who dosed with Placebo in both sequences (AB and BA) are included in this analysis'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.43', 'spread': '1.845', 'groupId': 'OG000'}, {'value': '1.47', 'spread': '1.874', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3565', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.90', 'ciLowerLimit': '-6.04', 'ciUpperLimit': '2.23', 'pValueComment': 'The threshold for statistical significance was p=0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Each co-primary endpoint was tested at two-sided 5% level of significance, with no adjustments for multiplicity.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 2 weeks', 'description': 'Change from baseline in gait speed (cm/sec) measured on an electronic walkway system under single task trial condition (meaning walking only) at the end of each two-week treatment period', 'unitOfMeasure': 'cm/sec', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'PRIMARY', 'title': 'Change in Gait Measurements (cm/Sec) Under Dual Task Condition From Baseline to the End of Each Double-blind Treatment Period Based on Computerized Gait Assessment Tools.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RVT-101 35 mg', 'description': 'RVT-101 35 mg: once daily, oral\n\nSubjects who dosed with RVT-101 in both sequences (AB and BA) are included in this analysis'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects who dosed with Placebo in both sequences (AB and BA) are included in this analysis'}], 'classes': [{'categories': [{'measurements': [{'value': '1.46', 'spread': '1.517', 'groupId': 'OG000'}, {'value': '1.63', 'spread': '1.518', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9220', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-3.73', 'ciUpperLimit': '3.38', 'pValueComment': 'The threshold for statistical significance was p=0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Each co-primary endpoint was tested at two-sided 5% level of significance, with no adjustments for multiplicity.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 2 weeks', 'description': 'Change from baseline in gait speed (cm/sec) measured on an electronic walkway system under dual task trial condition (meaning walking while performing another task) at the end of each two-week treatment period.', 'unitOfMeasure': 'cm/sec', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence 1: AB', 'description': 'RVT-101 35 mg: once daily, oral, 35-mg tablets in Period II\n\nPlacebo in Period IV'}, {'id': 'FG001', 'title': 'Sequence 2: BA', 'description': 'Placebo: once daily, oral, matching tablets in Period II\n\nRVT-101 35 mg: once daily, oral, 35-mg tablets in Period IV'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Safety Population', 'comment': 'The Safety population included subjects who took at least 1 dose of double-blind study drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Intent to Treat (ITT) Population', 'comment': 'Subjects took at least 1 dose of DB study drug and had at least 1 post-baseline assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Per-Protocol Population', 'comment': 'Subjects in the ITT population who had no major protocol violations', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'comment': 'Subjects in the ITT population who completed the study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '68 participants signed consent and were screened for participation. Of these, 40 entered a 2-week single-blind placebo run-in period with treatment with placebo qd. Subjects were allowed to re-screen if they failed the initial screening assessments. All subjects deemed eligible following run-in were randomized to a treatment group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sequence 1: AB', 'description': 'RVT-101 35 mg: once daily, oral, 35-mg tablets in Period II\n\nPlacebo in Period IV'}, {'id': 'BG001', 'title': 'Sequence 2: BA', 'description': 'Placebo: once daily, oral, matching tablets in Period II\n\nRVT-101 35 mg: once daily, oral, 35-mg tablets in Period IV'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '76.0', 'groupId': 'BG000', 'lowerLimit': '68', 'upperLimit': '86'}, {'value': '73.8', 'groupId': 'BG001', 'lowerLimit': '60', 'upperLimit': '83'}, {'value': '75.0', 'groupId': 'BG002', 'lowerLimit': '60', 'upperLimit': '86'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '27.312', 'groupId': 'BG000', 'lowerLimit': '19.23', 'upperLimit': '45.59'}, {'value': '25.898', 'groupId': 'BG001', 'lowerLimit': '16.01', 'upperLimit': '34.57'}, {'value': '26.680', 'groupId': 'BG002', 'lowerLimit': '16.01', 'upperLimit': '45.59'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'Safety Population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-07', 'size': 912537, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-11-21T12:30', 'hasProtocol': True}, {'date': '2017-11-29', 'size': 747958, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-11-30T10:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-17', 'studyFirstSubmitDate': '2016-09-16', 'resultsFirstSubmitDate': '2019-01-15', 'studyFirstSubmitQcDate': '2016-09-19', 'lastUpdatePostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-17', 'studyFirstPostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Gait Speed (cm/Sec) Measurements From Baseline to the End of Each Double-blind Treatment Period Based on Computerized Gait Assessment Tools.', 'timeFrame': 'Baseline, 2 weeks', 'description': 'Change from baseline in gait speed (cm/sec) measured on an electronic walkway system under single task trial condition (meaning walking only) at the end of each two-week treatment period'}, {'measure': 'Change in Gait Measurements (cm/Sec) Under Dual Task Condition From Baseline to the End of Each Double-blind Treatment Period Based on Computerized Gait Assessment Tools.', 'timeFrame': 'Baseline, 2 weeks', 'description': 'Change from baseline in gait speed (cm/sec) measured on an electronic walkway system under dual task trial condition (meaning walking while performing another task) at the end of each two-week treatment period.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['RVT-101', 'intepirdine', "Alzheimer's disease", 'Dementia with Lewy bodies', 'Lewy body dementia', "Parkinson's Disease Dementia"], 'conditions': ["Alzheimer's Disease", 'Dementia With Lewy Bodies', "Parkinson's Disease Dementia"]}, 'descriptionModule': {'briefSummary': "This study seeks to evaluate the effect of intepirdine (RVT-101) on gait and balance in patients with Alzheimer's Disease, Dementia with Lewy Bodies or Parkinson's Disease Dementia.", 'detailedDescription': 'To assess the effect of intepirdine (RVT-101) versus placebo on quantitative and qualitative gait and balance parameters.\n\nEach subject will be randomized 1:1 to one of the following sequences:\n\nSequence 1: AB = RVT-101 35 mg during the early treatment period and Placebo during the late treatment period\n\nSequence 2: BA = Placebo during the early treatment period and RVT-101 35 mg during the late treatment period\n\nTreatment A = RVT-101 35 mg once daily.\n\nTreatment B = Placebo once daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\nMale or female subject with a clinical diagnosis of Alzheimer's disease (AD), dementia with Lewy bodies (DLB), or Parkinson's disease dementia (PDD).\n\nMini Mental State Examination score 14 to 26 Gait impairment, as assessed by history gathered by the clinical investigator and quantitative measurements Subjects must be on stable background acetylcholinesterase inhibitor therapy\n\nKey Exclusion Criteria:\n\nHistory and/or evidence of any other CNS disorder that could be interpreted as a cause of dementia (in the opinion of the investigator) Any clinically relevant concomitant disease which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study."}, 'identificationModule': {'nctId': 'NCT02910102', 'briefTitle': 'Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With Dementia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sio Gene Therapies'}, 'officialTitle': "A Phase 2, Double-blind, Randomized, Placebo-controlled Crossover Study Evaluating the Effect of RVT-101 on Gait and Balance in Subjects With Alzheimer's Disease, Dementia With Lewy Bodies, or Parkinson's Disease Dementia", 'orgStudyIdInfo': {'id': 'RVT-101-2003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Sequence AB', 'description': 'RVT-101 35 mg in Period II and Placebo in Period IV', 'interventionNames': ['Drug: RVT-101 35 mg', 'Drug: Placebo']}, {'type': 'OTHER', 'label': 'Sequence BA', 'description': 'Placebo in Period II and RVT-101 35 mg in Period IV', 'interventionNames': ['Drug: RVT-101 35 mg', 'Drug: Placebo']}], 'interventions': [{'name': 'RVT-101 35 mg', 'type': 'DRUG', 'description': 'RVT-101 once daily, oral, 35-mg tablets', 'armGroupLabels': ['Sequence AB', 'Sequence BA']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo once daily, oral', 'armGroupLabels': ['Sequence AB', 'Sequence BA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'US101', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '93065', 'city': 'Simi Valley', 'state': 'California', 'country': 'United States', 'facility': 'US118', 'geoPoint': {'lat': 34.26945, 'lon': -118.78148}}, {'zip': '92591', 'city': 'Temecula', 'state': 'California', 'country': 'United States', 'facility': 'US117', 'geoPoint': {'lat': 33.49364, 'lon': -117.14836}}, {'zip': '33431', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'US115', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33009', 'city': 'Hallandale', 'state': 'Florida', 'country': 'United States', 'facility': 'US109', 'geoPoint': {'lat': 25.9812, 'lon': -80.14838}}, {'zip': '33137', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'US116', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32502', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'US108', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '31909', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'US106', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'US107', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'US102', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'US111', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Ilise Lombardo, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Axovant Sciences, Inc., Senior VP Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Axovant Sciences Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}