Multiple Sclerosis Clinical Trial
Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally in Patients With Relapsing-remitting Multiple Sclerosis
Summary
This study consisted of a two year dose blinded phase during which patients received one of five doses of siponimod (10, 2, 1.25, 0.5 or 0.25mg) following which patients were switched to open label treatment with siponimod 2mg for approximately a further 3 years. It will provide data on long term safety, tolerability and efficacy of siponimod in the RRMS patient population
Full Description
This study was prematurely discontinued after approximately 5 years. The decision to prematurely discontinue the study was not taken due to safety-related concerns, rather due to a decision to focus the development of siponimod in MS on a different population.
Eligibility Criteria
Inclusion Criteria:
Patients completed the core study BAF312A2201
Written informed consent provided before any assessment of the extension study
Female patients at risk of becoming pregnant must have a negative pregnancy test and use simultaneously two forms of effective contraception
Exclusion Criteria:
Newly diagnosed systemic disease other than MS (which may require immunosuppressive treatment)
Malignancies, diabetes, significant cardiovascular and pulmonary diseases and conditions
Active infections
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There are 46 Locations for this study
Miami Florida, 33136, United States
Pompano Beach Florida, 33060, United States
Tallahassee Florida, 32308, United States
Chicago Illinois, 60637, United States
Grand Rapids Michigan, 49525, United States
Akron Ohio, 44320, United States
Greenville South Carolina, 29607, United States
Seattle Washington, 98122, United States
Ottawa Ontario, K1H 8, Canada
Gatineau Quebec, J9J 0, Canada
Greenfield Park Quebec, J4V 2, Canada
Helsinki , 00930, Finland
Tampere , FIN-3, Finland
Dresden , 01307, Germany
Ibbenbueren , 49477, Germany
Muenchen , 81675, Germany
Muenster , 48149, Germany
Budapest , 1076, Hungary
Budapest , 1145, Hungary
Debrecen , 4032, Hungary
Veszprem , H-820, Hungary
Montichiari BS, 25018, Italy
Chieti CH, 66100, Italy
Roma RM, 00133, Italy
Roma RM, 00152, Italy
Bergen , 5021, Norway
Oslo , 0424, Norway
Lodz , 90-32, Poland
Lublin , 20-95, Poland
Warszawa , 02-95, Poland
Kazan , 42010, Russian Federation
Moscow , 12536, Russian Federation
Moscow , 12701, Russian Federation
Saint Petersburg , 19702, Russian Federation
Saint-Petersburg , 19404, Russian Federation
Sevilla Andalucia, 41009, Spain
Barcelona Catalunya, 08035, Spain
Valencia Comunidad Valenciana, 46026, Spain
Basel , 4031, Switzerland
Lugano , 6900, Switzerland
Zuerich , 8091, Switzerland
Ankara , 06100, Turkey
Haseki / Istanbul , 34096, Turkey
Istanbul , 34093, Turkey
Izmir , 35340, Turkey
Kocaeli , 41380, Turkey
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