Viewing Study NCT01127750

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Ignite Creation Date: 2025-12-24 @ 4:58 PM

Ignite Modification Date: 2025-12-28 @ 1:32 PM

Study NCT ID: NCT01127750

Status: COMPLETED

Last Update Posted: 2017-02-23

First Post: 2010-05-19

Is NOT Gene Therapy: True

Has Adverse Events: False

Brief Title: Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068876', 'term': 'Fingolimod Hydrochloride'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2417}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-21', 'studyFirstSubmitDate': '2010-05-19', 'studyFirstSubmitQcDate': '2010-05-19', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS', 'timeFrame': '4 months'}], 'secondaryOutcomes': [{'measure': 'Incidence of macular edema', 'timeFrame': '4 months'}, {'measure': 'Incidence of bradyarrhythmic electrocardiograms (ECGs)', 'timeFrame': '4 months'}, {'measure': 'Patient reported outcomes indices in multiple sclerosis (PRIMUS), short form health survey-12, and treatment satisfaction questionnaire for medication (TSQM-9)', 'timeFrame': '4 months'}]}, 'conditionsModule': {'keywords': ['Relapsing multiple sclerosis', 'MS', 'safety', 'tolerability', 'health outcomes'], 'conditions': ['Relapsing Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '24221641', 'type': 'RESULT', 'citation': 'Gold R, Comi G, Palace J, Siever A, Gottschalk R, Bijarnia M, von Rosenstiel P, Tomic D, Kappos L; FIRST Study Investigators. Assessment of cardiac safety during fingolimod treatment initiation in a real-world relapsing multiple sclerosis population: a phase 3b, open-label study. J Neurol. 2014 Feb;261(2):267-76. doi: 10.1007/s00415-013-7115-8. Epub 2013 Nov 13.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years of age, must have relapsing MS\n\nExclusion Criteria:\n\n* Patients with a type of MS that is not relapsing\n* Patients with history of chronic immune disease\n* Patients with a history of certain cancers\n* Diabetic patients with certain eye disorders\n* Patients who are on certain immunosuppressive medications or heart medications\n* Patients with certain heart conditions\n* Patients with certain lung conditions\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01127750', 'briefTitle': 'Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 4-month, Open-label, Multi-center Study to Explore Tolerability and Safety and Health Outcomes of FTY720 in Patients With Relapsing Forms of Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'CFTY720D2316'}, 'secondaryIdInfos': [{'id': '2010-019029-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FTY720', 'interventionNames': ['Drug: FTY720']}], 'interventions': [{'name': 'FTY720', 'type': 'DRUG', 'armGroupLabels': ['FTY720']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3128', 'city': 'Box Hill', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -37.81887, 'lon': 145.12545}}, {'zip': '3084', 'city': 'Heidelberg', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'zip': '2217', 'city': 'Kogarah', 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