Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-25 @ 11:52 AM
Study NCT ID:
NCT04327661
Status:
COMPLETED
Last Update Posted:
2024-12-11
First Post:
2020-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Motion Syros: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness
Sponsor:
Organization:
Raw JSON
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The VA is a 1-item questionnaire to objectively measure the incidence of emesis. Participants will indicate whether or not they have vomited. The Count of Participants indicates participants who vomited.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tradipitant High Dose', 'description': 'Tradipitant: Oral Capsule'}, {'id': 'FG001', 'title': 'Tradipitant Low Dose', 'description': 'Tradipitant: Oral Capsule'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo: Oral Capsule'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '123'}, {'groupId': 'FG002', 'numSubjects': '122'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '123'}, {'groupId': 'FG002', 'numSubjects': '122'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}, {'value': '366', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Tradipitant High Dose', 'description': 'Tradipitant: Oral Capsule'}, {'id': 'BG001', 'title': 'Tradipitant Low Dose', 'description': 'Tradipitant: Oral Capsule'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo: Oral Capsule'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}, {'value': '366', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '47.7', 'spread': '14.84', 'groupId': 'BG000'}, {'value': '49.6', 'spread': '14.40', 'groupId': 'BG001'}, {'value': '48.6', 'spread': '13.48', 'groupId': 'BG002'}, {'value': '48.6', 'spread': '14.23', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}, {'value': '366', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '244', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}, {'value': '366', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}, {'value': '306', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}, {'value': '366', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}, {'value': '366', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}, {'value': '366', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}, {'value': '366', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}, {'value': '366', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}, {'value': '310', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}, {'value': '366', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}, {'value': '366', 'groupId': 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{'largeDocumentModule': {'largeDocs': [{'date': '2022-11-07', 'size': 166882, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-19T13:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 366}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2020-03-26', 'resultsFirstSubmitDate': '2024-10-29', 'studyFirstSubmitQcDate': '2020-03-26', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-19', 'studyFirstPostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevention of Vomiting Measured by Vomiting Assessment (VA)', 'timeFrame': '1 day', 'description': 'Prevention of vomiting measured by Vomiting Assessment (VA) score in tradipitant high dose. The VA is a 1-item questionnaire to objectively measure the incidence of emesis. Participants will indicate whether or not they have vomited. The Count of Participants indicates participants who vomited.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Motion Sickness']}, 'referencesModule': {'references': [{'pmid': '40103934', 'type': 'DERIVED', 'citation': 'Polymeropoulos VM, Kiely L, Bushman ML, Sutherland EB, Goldberg AR, Pham AX, Miller CR, Mourad R, Davis TR, Pham NV, Morgan DB, Giles AK, Xiao C, Polymeropoulos CM, Birznieks G, Polymeropoulos MH. Motion Syros: tradipitant effective in the treatment of motion sickness; a multicenter, randomized, double-blind, placebo-controlled study. Front Neurol. 2025 Mar 4;16:1550670. doi: 10.3389/fneur.2025.1550670. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'A multi-center, randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in subjects affected by motion sickness during travel'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of motion sickness\n* Age 18-75\n\nExclusion Criteria:\n\n* Nausea-inducing disorder other than motion sickness\n* BMI\\>40\n* History of intolerance and/or hypersensitivity to Neurokinin-1 Receptor antagonists'}, 'identificationModule': {'nctId': 'NCT04327661', 'briefTitle': 'Motion Syros: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vanda Pharmaceuticals'}, 'officialTitle': 'Motion Syros: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness During Travel', 'orgStudyIdInfo': {'id': 'VP-VLY-686-3401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tradipitant High Dose', 'interventionNames': ['Drug: Tradipitant']}, {'type': 'EXPERIMENTAL', 'label': 'Tradipitant Low Dose', 'interventionNames': ['Drug: Tradipitant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tradipitant', 'type': 'DRUG', 'description': 'Oral Capsule', 'armGroupLabels': ['Tradipitant High Dose', 'Tradipitant Low Dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral Capsule', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Research Network, LLC', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90025', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Santa Monica Clinical Trials', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Gulfcoast Psychiatric Associates', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33162', 'city': 'North Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Harmony Clinical Research', 'geoPoint': {'lat': 25.93315, 'lon': -80.16255}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Avita Clinical Research', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '02169', 'city': 'Quincy', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beacon Clinical Research', 'geoPoint': {'lat': 42.25288, 'lon': -71.00227}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Manhattan Medical Research', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanda Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}