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 Full Description

Full Description

This study had two parts, a Core Part and an Extension Part. The Core Part of the study was a randomized, multicenter, double-blind, placebo-controlled parallel-group study in patients with secondary progressive multiple sclerosis (SPMS). Eligible patients were randomized (2:1) to receive either siponimod or placebo. The duration of the Core Part of the study was variable for each patient, given that this was an event-driven study and terminated when a pre-defined number of confirmed disability progression (CDP) events had occurred irrespective of duration of individual patient participation. Patients who had 6-month CDP during the Treatment Epoch of the Core Part were provided with options that included starting treatment with open label siponimod as rescue medication.

Patients who were eligible to enter the Extension Part received open label siponimod.

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

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 287 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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Hollywood Florida, 33024, 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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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
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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
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Freehold New Jersey, 07728, United States
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Albuquerque New Mexico, 87131, United States
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New York New York, 10017, United States
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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
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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
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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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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 , 10003, 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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Bordeaux Cedex , 33076, France
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Caen , 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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Nancy , 54035, 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
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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
Novartis Investigative Site
Siegen , 57076, Germany
Novartis Investigative Site
Stade , 21682, Germany
Novartis Investigative Site
Stadtroda , 07646, Germany
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Teupitz , 15755, Germany
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Tuebingen , 72076, Germany
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Ulm , 89073, Germany
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Ulm , 89081, Germany
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Unterhaching , 82008, Germany
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Wiesbaden , 65191, Germany
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Wuerzburg , 97080, Germany
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Athens , 106 7, Greece
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Heraklion Crete , 711 1, Greece
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Thessaloniki , GR 54, Greece
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Budapest HUN, 1135, 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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Budapest , 1145, Hungary
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Budapest , 1204, 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 4 , D04 T, Ireland
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Dublin 9 , D09, 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 , 26086, 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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Amsterdam , 1105 , Netherlands
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Breda , 4818 , 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 , 1649 , Portugal
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Porto , 4099-, Portugal
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Bucharest , 02012, Romania
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Bucharest , 05009, Romania
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Constanta , 90059, Romania
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Suceava , 72752, Romania
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Targu Mures , 54013, Romania
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Timisoara , 30073, Romania
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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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Badalona Catalunya, 08916, Spain
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Barcelona Catalunya, 08003, Spain
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Barcelona Catalunya, 08035, Spain
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Valencia Comunidad Valenciana, 46010, 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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Barcelona , 08041, Spain
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Madrid , 28040, Spain
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Madrid , 28222, Spain
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Valencia , 46026, 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
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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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