Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients
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
2 other identifiers
interventional
2,417
22 countries
284
Brief Summary
This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2010
284 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 19, 2010
CompletedFirst Posted
Study publicly available on registry
May 21, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFebruary 23, 2017
February 1, 2017
1.4 years
May 19, 2010
February 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS
4 months
Secondary Outcomes (3)
Incidence of macular edema
4 months
Incidence of bradyarrhythmic electrocardiograms (ECGs)
4 months
Patient reported outcomes indices in multiple sclerosis (PRIMUS), short form health survey-12, and treatment satisfaction questionnaire for medication (TSQM-9)
4 months
Study Arms (1)
FTY720
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- years of age, must have relapsing MS
You may not qualify if:
- Patients with a type of MS that is not relapsing
- Patients with history of chronic immune disease
- Patients with a history of certain cancers
- Diabetic patients with certain eye disorders
- Patients who are on certain immunosuppressive medications or heart medications
- Patients with certain heart conditions
- Patients with certain lung conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (289)
Novartis Investigative Site
Box Hill, 3128, Australia
Novartis Investigative Site
Heidelberg, 3084, Australia
Novartis Investigative Site
Kogarah, 2217, Australia
Novartis Investigative Site
Liverpool, 2170, Australia
Novartis Investigative Site
Woodville South, 5011, Australia
Novartis Investigational Site
Linz, A-4020, Austria
Novartis Investigational Site
Vienna, 1010, Austria
Novartis Investigational Site
Vienna, 1090, Austria
Novartis Investigational Site
Bruges, 8000, Belgium
Novartis Investigational Site
Brussels, 1070, Belgium
Novartis Investigational Site
Brussels, 1200, Belgium
Novartis Investigational Site
Charleroi, 6000, Belgium
Novartis Investigational Site
Leuven, 3000, Belgium
Novartis Investigational Site
Melsbroek, 1820, Belgium
Novartis Investigational Site
Overpelt, 3900, Belgium
Novartis Investigational Site
Sijsele, 8340, Belgium
Novartis Investigational Site
Tinlot, 4557, Belgium
Novartis Investigational Site
Wilrijk, 2610, Belgium
Novartis Investigational Site
Montreal, H2L 4M1, Canada
Novartis Investigational Site
Québec, G1J 1Z4, Canada
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Victoria, V8R 1J8, Canada
Novartis Investigational Site
Prague, 128 02, Czechia
Novartis Investigational Site
Teplice, 415 29, Czechia
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Aarhus, DK-8000, Denmark
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Copenhagen, 2100, Denmark
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Helsinki, 00100, Finland
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Turku, 20520, Finland
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Aachen, 52062, Germany
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Aachen, 52062, Germany
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Aalen, 73430, Germany
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Abensberg, 93326, Germany
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Achim, 28832, Germany
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Alzenau in Unterfranken, 63755, Germany
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Aschaffenburg, 63739, Germany
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Attenberg, 04600, Germany
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Augsburg, 86156, Germany
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Bad Honnef, 53604, Germany
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Bad Krozingen, 79189, Germany
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Bad Mergentheim, 97980, Germany
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Bad Neustadt / Saale, 97616, Germany
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Bamberg, 96047, Germany
Novartis Investigational Site
Bamberg, 96049, Germany
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Bayreuth, 95445, Germany
Novartis Investigative Site
Berlin, 10117, Germany
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Berlin, 10178, Germany
Novartis Investigative Site
Berlin, 10625, Germany
Novartis Investigative Site
Berlin, 10713, Germany
Novartis Investigative Site
Berlin, 10785, Germany
Novartis Investigative Site
Berlin, 10961, Germany
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Berlin, 12103, Germany
Novartis Investigative Site
Berlin, 12163, Germany
Novartis Investigative Site
Berlin, 12351, Germany
Novarris Investigative Site
Berlin, 13088, Germany
Novartis Investigative Site
Berlin, 13347, Germany
Novartis Investigative Site
Berlin, 13439, Germany
Novartis Investigative Site
Berlin, 13507, Germany
Novartis Investigative Site
Berlin, 14163, Germany
Novartis Investigative Site
Bielefeld, 33602, Germany
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Bielefeld, 33617, Germany
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Bielefeld, 33647, Germany
Novartis Investigational Site
Bochum, 44787, Germany
Novartis Investigative Site
Bochum, 44789, Germany
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Bochum, 44791, Germany
Novaratis Investigative Site
Bochum, 44892, Germany
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Bogen, 94327, Germany
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Bonn, 53105, Germany
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Bonn, 53117, Germany
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Böblingen, 71034, Germany
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Braunschweig, 38126, Germany
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Buchholz, 21244, Germany
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Chemnitz, 09117, Germany
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Cologne, 50924, Germany
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Cologne, 50935, Germany
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Cologne, 51109, Germany
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Dillingen, 89407, Germany
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Dresden, 01307, Germany
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Düsseldorf, 40211, Germany
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Eisenach, 99817, Germany
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Emden, 26721, Germany
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Emmendingen, 79312, Germany
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Erbach im Odenwald, 64711, Germany
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Erfurt, 99089, Germany
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Erlangen, 91054, Germany
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Essen, 103949, Germany
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Essen, 45131, Germany
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Essen, 45138, Germany
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Frankfurt, 60488, Germany
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Frankfurt, 60528, Germany
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Freiburg im Breisgau, 79106, Germany
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Greifswald, 17487, Germany
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Grevenbroich, 41515, Germany
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Hamburg, 20099, Germany
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Hamburg, 20249, Germany
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Hamburg, 20354, Germany
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Hamburg, 22083, Germany
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Hamburg, 22087, Germany
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Hamburg, 22179, Germany
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Hamburg, 22291, Germany
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Hamburg, 22297, Germany
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Hamburg, 22523, Germany
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Hanover, 30161, Germany
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Hanover, 30559, Germany
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Hanover, 30625, Germany
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Heidelberg, 69120, Germany
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Herborn, 35745, Germany
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Herdecke, 58313, Germany
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Herne, 44651, 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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Jena, 07743, Germany
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Kaltenkirchen, 24568, Germany
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Kandel, 76870, Germany
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Karlsruhe, 76133, Germany
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Karlstadt am Main, 97753, Germany
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Kassel, 34121, Germany
Neuroscience Research of the Berkshires
Krefeld, 47805, Germany
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Landshut, 84028, Germany
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Lappersdorf, 93138, Germany
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Leipzig, 04275, Germany
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Lengerich, 49525, Germany
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Lohr a. Main, 79816, Germany
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Ludwigshafen, 67059, Germany
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Ludwigshafen, 67063, Germany
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Magdeburg, 39120, Germany
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Mainz, 55101, Germany
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Mannheim, 68159, Germany
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Marburg, 35033, Germany
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Marburg, 35039, Germany
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Mittweida, 09648, Germany
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Mönchengladbach, 41063, Germany
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München, 80331, Germany
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München, 81241, Germany
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München, 81377, Germany
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München, 81675, Germany
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München, 81825, Germany
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München, 81829, Germany
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Münster, 48149, Germany
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Nagold, 72202, Germany
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Neu-Ulm, 89231, Germany
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Neuburg am Inn, 86633, Germany
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Neuruppin, 16816, Germany
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Nuremberg, 90461, Germany
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Oldenburg, 26122, Germany
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Osnabrück, 49076, Germany
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Ostfildern, 73760, Germany
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Pforzheim, 75172, Germany
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Potsdam, 14467, Germany
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Potsdam, 14471, Germany
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Prien am Chiemsee, 83209, Germany
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Regensburg, 93053, Germany
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Rostock, 18147, Germany
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Rösrath, 51503, Germany
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Rüdersdorf, 15562, Germany
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Schwarzenbruck, 90592, Germany
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Schwendi, 88477, Germany
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Siegen, 57072, Germany
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Sigmaringen, 72488, Germany
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Sinsheim, 74889, Germany
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Stade, 21682, Germany
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Stuttgart, 70176, Germany
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Stuttgart, 70178, Germany
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Stuttgart, 70182, Germany
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Stuttgart, 70191, Germany
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Teupitz, 15755, Germany
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Tübingen, 72076, Germany
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Ulm, 89073, Germany
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Unterhaching, 82008, Germany
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Wendlingen, 73240, Germany
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Wermsdorf, 04779, Germany
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Westerstede, 26655, Germany
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Wiesbaden, 65183, Germany
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Wiesbaden, 65191, Germany
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Wuppertal, 42283, Germany
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Würzburg, 97080, Germany
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Alexandroupoli, 68100, Greece
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Athens, 10675, Greece
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Athens, 15123, Greece
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Thessaloniki, 57001, Greece
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Thessaloniki, GR 570 10, Greece
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Budapest, 1083, Hungary
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Budapest, 1115, Hungary
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Budapest, 1204, Hungary
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Pécs, 7623, Hungary
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Szeged, H-6725, Hungary
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Cork, Ireland
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Dublin, Ireland
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Acquaviva delle Fonti, 70021, Italy
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Asti, 14100, Italy
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Bergamo, 24128, Italy
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Bologna, 40139, Italy
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Cagliari, 09126, Italy
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Catania, 95122, Italy
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Foggia, 71100, Italy
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Foggia, 71100, Italy
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Milan, 20132, Italy
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Napoli, 80131, Italy
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Napoli, 80132, Italy
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Napoli, 80138, Italy
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Palermo, 90146, Italy
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Pozzilli, 86077, Italy
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Ravenna, 48100, Italy
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Roma, 00135, Italy
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Roma, 00161, Italy
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Roma, 00168, Italy
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Roma, 00185, Italy
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Siena, 53100, Italy
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Udine, 33100, Italy
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Verona, 37134, Italy
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Vicenza, 36100, Italy
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Viterbo, 01100, Italy
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Amsterdam, 1061 AE, Netherlands
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Amsterdam, 1081 HV, Netherlands
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Blaricum, 1261 AN, Netherlands
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Breda, 4818 CK, Netherlands
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Enschede, 7513 ER, Netherlands
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Gouda, 2800 BB, Netherlands
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Tilburg, 5022 GC, Netherlands
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Lillehammer, 2609, Norway
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Molde, 6407, Norway
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Stavanger, 4868, Norway
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Bydgoszcz, 85-681, Poland
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Katowice, 40-594, Poland
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Lodz, 90-153, Poland
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Amadora, 2720-276, Portugal
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Coimbra, 3041-853, Portugal
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Lisbon, 1649-035, Portugal
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Porto, 4099-001, Portugal
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Porto, 4200-319, Portugal
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Kazan', 420021, Russia
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Kazan', 420097, Russia
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Moscow, 121356, Russia
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Moscow, 125367, Russia
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Moscow, 127018, Russia
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Nizhny Novgorod, 603018, Russia
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Nizhny Novgorod, 603155, Russia
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S.-Petersburg, 194044, Russia
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Saint Petersburg, 197376, Russia
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Samara, 443095, Russia
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Smolensk, 214019, Russia
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Yekaterinburg, 620102, Russia
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Banská Bystrica, 975 17, Slovakia
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Bratislava, 82606, Slovakia
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Trnava, 917 75, Slovakia
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Barcelona, 08025, Spain
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Barcelona, 08036, Spain
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Donostia / San Sebastian, 20014, Spain
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El Palmar, 30120, Spain
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Madrid, 28034, Spain
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Madrid, Spain
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Santa Cruz de Tenerife, 38009, Spain
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Santiago de Compostela, 15706, Spain
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Valencia, 46010, Spain
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Gothenburg, 413 45, Sweden
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Linköping, 581 85, Sweden
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Umeå, 901 85, Sweden
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Aarau, 5001, Switzerland
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Carouge, 1227, Switzerland
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Geneva, 1211, Switzerland
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Lausanne, 1011, Switzerland
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Lugano, 6900, Switzerland
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Sankt Gallen, 9007, Switzerland
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Zurich, 8091, Switzerland
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Antalya, 07070, Turkey (Türkiye)
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Gaziantep, 27070, Turkey (Türkiye)
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Istanbul, 34096, Turkey (Türkiye)
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Istanbul, 34098, Turkey (Türkiye)
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Samsun, Turkey (Türkiye)
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Trabzon, 61080, Turkey (Türkiye)
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Birmingham, B15 2TH, United Kingdom
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Brighton, BN2 2BE, United Kingdom
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Dundee, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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Essex, RM7 0BE, United Kingdom
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Great Yarmouth, NR31 6LA, United Kingdom
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Headington, OX3 9DU, United Kingdom
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Liverpool, L9 7LJ, United Kingdom
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London, SW17 0QT, United Kingdom
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London, W8 6RF, United Kingdom
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Middlesbrough, TS4 3BW, United Kingdom
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Newcastle upon Tyne, NE1 4LP, United Kingdom
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Northampton, NN1 5BD, United Kingdom
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Norwick, NR4 7UY, United Kingdom
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Poole, BH15 2JB, United Kingdom
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Salford, M6 8HD, United Kingdom
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Sheffield, S10 2JF, United Kingdom
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Stoke-on-Trent, ST4 6QG, United Kingdom
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Swindon, SN3 6BB, United Kingdom
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Truro, TR1 3LJ, United Kingdom
Related Publications (1)
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.
PMID: 24221641RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2010
First Posted
May 21, 2010
Study Start
May 1, 2010
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
February 23, 2017
Record last verified: 2017-02