Multiple Sclerosis Clinical Trial

Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)

Summary

Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment duration in patients with secondary progressive multiple sclerosis (Core Part) followed by extended treatment with open-label BAF312 to obtain data on long-term safety, tolerability and efficacy (Extension Part).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Prior history of relapsing remitting MS
SPMS defined as progressive increase of disability over at least 6 months
EDSS score of 3.0 to 6.5
No relapse of corticosteroid treatment within 3 months

Exclusion Criteria:

Women of child bearing potential must use reliable forms of contraception.
Diagnosis of Macular edema during screening period
Any medically unstable condition determined by investigator.
Unable to undergo MRI scans
Hypersensitivity to any study drugs or drugs of similar class Other protocol defined inclusion/exclusion may apply.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1651

Study ID:

NCT01665144

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 285 Locations for this study

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Novartis Investigative Site
Phoenix Arizona, 85032, United States
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Berkeley California, 94705, United States
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Los Angeles California, 90033, United States
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Oceanside California, 92056, United States
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Sacramento California, 95817, United States
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Aurora Colorado, 80045, United States
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Basalt Colorado, 81621, United States
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Boulder Colorado, 80301, United States
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Colorado Springs Colorado, 80907, United States
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Englewood Colorado, 80113, United States
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Fairfield Connecticut, 06824, United States
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Delray Beach Florida, 33445, United States
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Jacksonville Florida, 32209, United States
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Maitland Florida, 32751, United States
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Ormond Beach Florida, 32174, United States
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Port Charlotte Florida, 33952, United States
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Sunrise Florida, 33351, United States
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Tampa Florida, 33609, United States
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Tampa Florida, 33612, United States
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Vero Beach Florida, 32960, United States
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Chicago Illinois, 60612, United States
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Evanston Illinois, 60201, United States
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Flossmoor Illinois, 60422, United States
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Lenexa Kansas, 66212, United States
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Baltimore Maryland, 21287, United States
Novartis Investigative Site
Ann Arbor Michigan, 48109, United States
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Detroit Michigan, 48201, United States
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Detroit Michigan, 48202, United States
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Plymouth Minnesota, 55446, United States
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Saint Louis Missouri, 63131, United States
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Las Vegas Nevada, 89106, United States
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Lebanon New Hampshire, 03756, United States
Novartis Investigative Site
Freehold New Jersey, 07728, United States
Novartis Investigative Site
Albuquerque New Mexico, 87131, United States
Novartis Investigative Site
New York New York, 10017, United States
Novartis Investigative Site
New York New York, 10029, United States
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Patchogue New York, 11772, United States
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Stony Brook New York, 11794, United States
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Charlotte North Carolina, 28207, United States
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Akron Ohio, 44320, United States
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Dayton Ohio, 45408, United States
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Portland Oregon, 97225, United States
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Springfield Oregon, 97477, United States
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Philadelphia Pennsylvania, 19104, United States
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Providence Rhode Island, 02905, United States
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Dallas Texas, 75216, United States
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Lubbock Texas, 79410, United States
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San Antonio Texas, 78258, United States
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Burlington Vermont, 05401, United States
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Seattle Washington, 98101, United States
Novartis Investigative Site
Seattle Washington, 98122, United States
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Milwaukee Wisconsin, 53215, United States
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Caba Buenos Aires, 1425, Argentina
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Caba Buenos Aires, C1181, Argentina
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Caba Buenos Aires, C1428, Argentina
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Capital Federal Buenos Aires, 1424, Argentina
Novartis Investigative Site
Buenos Aires , C1424, Argentina
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Cordoba , X5000, Argentina
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Camperdown New South Wales, 2050, Australia
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Kogarah New South Wales, 2217, Australia
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Liverpool New South Wales, 2170, Australia
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Heidelberg Victoria, 3084, Australia
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Parkville Victoria, 3050, Australia
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Klagenfurt , 9020, Austria
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Vienna , 1090, Austria
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Wien , 1010, Austria
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Edegem Antwerpen, 2650, Belgium
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Brugge , 8000, Belgium
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Bruxelles , 1070, Belgium
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Fraiture En Condroz , 4557, Belgium
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Gent , 9000, Belgium
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Leuven , 3000, Belgium
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Pelt , 3900, Belgium
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Sijsele , 8340, Belgium
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Sofia , 1113, Bulgaria
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Sofia , 1413, Bulgaria
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Sofia , 1431, Bulgaria
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Varna , 9010, Bulgaria
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Calgary Alberta, T2N 2, Canada
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Edmonton Alberta, T6G 2, Canada
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Burnaby British Columbia, V5G 2, Canada
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Halifax Nova Scotia, B3H 4, Canada
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Kingston Ontario, K7L 2, Canada
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Ottawa Ontario, K1H 8, Canada
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Toronto Ontario, M4N 3, Canada
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Greenfield Park Quebec, J4V 2, Canada
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Montreal Quebec, H2X 0, Canada
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Montreal Quebec, H3A 2, Canada
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Beijing Beijing, 10003, China
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Beijing Beijing, 10073, China
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Changchun Jilin, 13002, China
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Taiyuan Shanxi, 03000, China
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XI An Shanxi, 71003, China
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Chengdu Sichuan, 61004, China
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Beijing , 10002, China
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Beijing , 10073, China
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Shanghai , 20004, China
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Brno Czech Rep., 625 0, Czechia
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Teplice Czech Republic, 415 0, Czechia
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JIhlava , 586 0, Czechia
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Prague 5 , 150 0, Czechia
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Praha , 12808, Czechia
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Tallinn , 10138, Estonia
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Tallinn , 10617, Estonia
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Nancy Cedex, 54035, France
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Bordeaux Cedex , 33076, France
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CAEN Cedex , 14033, France
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Lille , 59037, France
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Marseille Cedex 05 , 13885, France
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Montpellier , 34295, France
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Nimes , 30029, France
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Paris 13 , 75651, France
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Rennes , 35043, France
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St Herblain , 44800, France
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Strasbourg , 67091, France
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Regensburg Bavaria, 93053, Germany
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Aschaffenburg , 63739, Germany
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Bad Mergentheim , 97980, Germany
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Bayreuth , 95445, Germany
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Berg , 82335, Germany
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Berlin , 10713, Germany
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Berlin , 13347, Germany
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Bielefeld , 33647, Germany
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Boblingen , 71032, Germany
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Bochum , 44791, Germany
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Bonn , 53111, Germany
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Dresden , 01307, Germany
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Erbach , 64711, Germany
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Erlangen , 91054, Germany
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Frankfurt , 60313, Germany
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Freiburg , 79106, Germany
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Hamburg , 20249, Germany
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Hamburg , 22083, Germany
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Hannover , 30171, Germany
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Hannover , 30625, Germany
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Heidelberg , 69120, Germany
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Homburg , 66421, Germany
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Itzehoe , 25524, Germany
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Jena , 07740, Germany
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Kassel , 34121, Germany
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Leipzig , 04103, Germany
Novartis Investigative Site
Leipzig , 04107, Germany
Novartis Investigative Site
Muenchen , 80377, Germany
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Muenster , 48149, Germany
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Neuburg an der Donau , 86633, Germany
Novartis Investigative Site
Oldenburg , 26122, Germany
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Potsdam , 14471, Germany
Novartis Investigative Site
Prien , 83209, Germany
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Rostock , 18057, Germany
Novartis Investigative Site
Schwendi , 88477, Germany
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Siegen , 57076, Germany
Novartis Investigative Site
Stade , 21682, Germany
Novartis Investigative Site
Stadtroda , 07646, Germany
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Teupitz , 15755, Germany
Novartis Investigative Site
Ulm , 89073, Germany
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Ulm , 89081, Germany
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Unterhaching , 82008, Germany
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Wiesbaden , 65191, Germany
Novartis Investigative Site
Athens , 106 7, Greece
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Heraklion Crete , 711 1, Greece
Novartis Investigative Site
Thessaloniki , GR 54, Greece
Novartis Investigative Site
Budapest HUN, 1135, Hungary
Novartis Investigative Site
Budapest HUN, 1145, Hungary
Novartis Investigative Site
Budapest HUN, 1204, Hungary
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Esztergom HUN, 2500, Hungary
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Balassagyarmat , 2660, Hungary
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Budapest , 1085, Hungary
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Budapest , 1106, Hungary
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Eger , H-330, Hungary
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Miskolc , 3526, Hungary
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Nyiregyhaza , 4400, Hungary
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Veszprem , H 820, Hungary
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Dublin 9 D9, D09, Ireland
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Dublin 4 , D04 T, Ireland
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Jerusalem , 91120, Israel
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Ramat Gan , 52621, Israel
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Genova GE, 16132, Italy
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Milano MI, 20122, Italy
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Milano MI, 20132, Italy
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Cefalu PA, 90015, Italy
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Roma RM, 00133, Italy
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Roma RM, 00152, Italy
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Roma RM, 00161, Italy
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Roma RM, 00168, Italy
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Roma RM, 00179, Italy
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Napoli , 80131, Italy
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Toon-city Ehime, 791-0, Japan
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Asahikawa-city Hokkaido, 070-8, Japan
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Morioka Iwate, 020-8, Japan
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Kyoto-city Kyoto, 616-8, Japan
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Suita Osaka, 565 0, Japan
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Kawagoe Saitama, 350 8, Japan
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Tokorozawa city Saitama, 359 8, Japan
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Kodaira Tokyo, 187-8, Japan
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Ota-ku Tokyo, 145-0, Japan
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Shinjuku ku Tokyo, 162 8, Japan
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Shinjuku-ku Tokyo, 160 8, Japan
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Aomori , 030 8, Japan
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Chiba , 260 8, Japan
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Osaka , 556-0, Japan
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Riga LV, LV-10, Latvia
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Riga , LV 10, Latvia
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Riga , LV-10, Latvia
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Kaunas LTU, LT 50, Lithuania
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Klaipeda , LT-92, Lithuania
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Vilnius , LT-08, Lithuania
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Breda CK, 4818 , Netherlands
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Amsterdam , 1105 , Netherlands
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Eindhoven , 5623 , Netherlands
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Hoorn , 1624 , Netherlands
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Sittard-Geleen , 6162 , Netherlands
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Tilburg , 5022 , Netherlands
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Grudziadz , 86 30, Poland
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Katowice , 40 57, Poland
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Kielce , 25 72, Poland
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Konskie , 26 20, Poland
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Krakow , 31-63, Poland
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Lodz , 90 32, Poland
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Poznan , 60-35, Poland
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Warszawa , 02-95, Poland
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Amadora , 2720-, Portugal
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Braga , 47102, Portugal
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Coimbra , 3000 , Portugal
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Lisboa , 16001, Portugal
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Porto , 4099-, Portugal
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Constanta Jud. Constanta, 90059, Romania
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Bucharest , 02012, Romania
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Bucharest , 05009, Romania
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Suceava , 72752, Romania
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Targu Mures , 54013, Romania
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Timisoara , 30073, Romania
Novartis Investigative Site
Barnaul , 65602, Russian Federation
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Kazan , 42004, Russian Federation
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Moscow , 11904, Russian Federation
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Moscow , 12701, Russian Federation
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Novosibirsk , 63000, Russian Federation
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Saint Petersburg , 19404, Russian Federation
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St. Petersburg , 19711, Russian Federation
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St. Petersburg , 19737, Russian Federation
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Ufa , 45000, Russian Federation
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Banska Bystrica , 97517, Slovakia
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Bratislava , 813 6, Slovakia
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Bratislava , 826 0, Slovakia
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Martin , 036 5, Slovakia
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Nitra , 94911, Slovakia
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Presov , 081 8, Slovakia
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Trencin , 91171, Slovakia
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Trnava , 917 7, Slovakia
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Malaga Andalucia, 29010, Spain
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Sevilla Andalucia, 41009, Spain
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Hospitalet de Llobregat Barcelona, 08907, Spain
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Barcelona Cataluna, 08026, Spain
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Badalona Catalunya, 08916, Spain
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Barcelona Catalunya, 08003, Spain
Novartis Investigative Site
Barcelona Catalunya, 08035, Spain
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Valencia Comunidad Valenciana, 46010, Spain
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Valencia Comunidad Valenciana, 46026, Spain
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El Palmar Murcia, 30120, Spain
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Bilbao Pais Vasco, 48013, Spain
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San Sebastian Pais Vasco, 20080, Spain
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Madrid , 28040, Spain
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Madrid , 28222, Spain
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Goeteborg , 413 4, Sweden
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Stockholm , 102 3, Sweden
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Stockholm , 10235, Sweden
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Aarau CH, 5001, Switzerland
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Basel , 4031, Switzerland
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Lausanne , 1011, Switzerland
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Lugano , 6900, Switzerland
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Luzern , 6000, Switzerland
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St Gallen , 9007, Switzerland
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Zuerich , 8091, Switzerland
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Istanbul TUR, 34098, Turkey
Novartis Investigative Site
Altunizade , 34662, Turkey
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Haseki Istanbul , 34096, Turkey
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Kocaeli , 41380, Turkey
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Mecidiyekoy Istanbul , 34394, Turkey
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Samsun , 55139, Turkey
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Trabzon , 61080, Turkey
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Salford Manchester, M6 8H, United Kingdom
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Headington Oxfordshire, OX3 9, United Kingdom
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Sheffield South Yorkshire, S10 2, United Kingdom
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Bristol , BS10 , United Kingdom
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Glasgow , G51 4, United Kingdom
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Leeds , LS1 3, United Kingdom
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Leicester , LE5 4, United Kingdom
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London , EC1A , United Kingdom
Novartis Investigative Site
London , W8 6R, United Kingdom
Novartis Investigative Site
Newcastle Upon Tyne , NE1 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1651

Study ID:

NCT01665144

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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