Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis

A Single Arm, Open-label, Multicenter Study Evaluating the Long-term Safety and Tolerability of 0.5 mg Fingolimod (FTY720) Administered Orally Once Daily in Patients With Relapsing Forms of Multiple Sclerosis

The purpose of this study was to collect long-term safety and tolerability, long-term efficacy, and health outcome data in all patients currently ongoing in the fingolimod multiple sclerosis clinical development program. This study combined all currently ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned studies into one single long-term extension protocol that provided patients with continuous treatment until fingolimod was registered, commercially available, and reimbursed in the respective countries.

Study Overview

• Status: Completed
• Conditions: Relapsing Forms of Multiple Sclerosis
• Intervention / Treatment: Drug: Fingolimod

Detailed Description

This study had two parts:

• Part 1, collecting long-term safety, tolerability, efficacy and health outcomes data through approximately 30-Jun-2016 until all end of study (EOS) visits of Part 1 and last follow-up visit through Jan-2017 and
• Part 2, collecting limited safety and tolerability data until approximately 30 Jun 2018, in a subset of patients who participated in Part 1, and other eligible patients from ongoing fingolimod trials.

• Study Type: Interventional
• Enrollment (Actual): 4125
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Cordoba, Argentina, X5004CDT
    • Novartis Investigative Site
  • Salta, Argentina, A4400BKZ
    • Novartis Investigative Site
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1428AQK
      • Novartis Investigative Site
    • Caba, Buenos Aires, Argentina, C1181ACH
      • Novartis Investigative Site
    • Caba, Buenos Aires, Argentina, 1425
      • Novartis Investigative Site
    • Capital Federal, Buenos Aires, Argentina, C1192AAW
      • Novartis Investigative Site
  • Mendoza
    • Guaymallen, Mendoza, Argentina, M5507XAD
      • Novartis Investigative Site
  • Provincia De Salta
    • Ciudad de Salta, Provincia De Salta, Argentina, A4406BPF
      • Novartis Investigative Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Novartis Investigative Site
  • Tucumán
    • San Miguel de Tucumán, Tucumán, Argentina, 4000
      • Novartis Investigative Site
• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Novartis Investigative Site
    • Chatswood, New South Wales, Australia, 2067
      • Novartis Investigative Site
    • Kogarah, New South Wales, Australia, 2217
      • Novartis Investigative Site
    • Liverpool, New South Wales, Australia, 2170
      • Novartis Investigative Site
    • North Gosford, New South Wales, Australia, 2250
      • Novartis Investigative Site
  • South Australia
    • Woodville, South Australia, Australia, 5011
      • Novartis Investigative Site
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Novartis Investigative Site
    • Fitzroy, Victoria, Australia, 3065
      • Novartis Investigative Site
    • Heidelberg, Victoria, Australia, 3084
      • Novartis Investigative Site
    • Parkville, Victoria, Australia, 3050
      • Novartis Investigative Site
• Austria
  • Linz, Austria, A-4020
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  • Salzburg, Austria, 5020
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  • St Poelten, Austria, 3100
    • Novartis Investigative Site
  • Vienna, Austria, 1090
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  • Vienna, Austria, 1010
    • Novartis Investigative Site
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
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• Belgium
  • Aalst, Belgium, 9300
    • Novartis Investigative Site
  • Brugge, Belgium, 8000
    • Novartis Investigative Site
  • Brussel, Belgium, 1090
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  • Bruxelles, Belgium, 1200
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  • Bruxelles, Belgium, 1070
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  • Charleroi, Belgium, 6000
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  • Fraiture En Condroz, Belgium, 4557
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  • Leuven, Belgium, 3000
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  • Melsbroek, Belgium, 1820
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  • Pelt, Belgium, 3900
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  • Sijsele, Belgium, 8340
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  • Sint-Truiden, Belgium, 3800
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  • Wilrijk, Belgium, 2610
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• Brazil
  • RJ
    • Rio De Janiero, RJ, Brazil, 20221-161
      • Novartis Investigative Site
    • Rio de Janeiro, RJ, Brazil, 21941-913
      • Novartis Investigative Site
    • Rio de Janeiro, RJ, Brazil, 20270-004
      • Novartis Investigative Site
  • RS
    • Porto Alegre, RS, Brazil, 90020-090
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  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
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  • SP
    • Campinas, SP, Brazil, 13083-970
      • Novartis Investigative Site
    • Ribeirao Preto, SP, Brazil, 14048-900
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• Canada
  • Quebec, Canada, G1J 1Z4
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  • Alberta
    • Edmonton, Alberta, Canada, T6G 2G3
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  • British Columbia
    • Burnaby, British Columbia, Canada, V5G 2X6
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    • Vancouver, British Columbia, Canada, V6T 1Z3
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    • Victoria, British Columbia, Canada, V8R 1J8
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  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
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  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
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    • London, Ontario, Canada, N6A 5A5
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    • Nepean, Ontario, Canada, K2G 6E2
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    • Ottawa, Ontario, Canada, K1H 8L6
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    • Toronto, Ontario, Canada, M5B 1W8
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  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2J2
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    • Montreal, Quebec, Canada, H1T 2M4
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    • Montreal, Quebec, Canada, H2L 4M1
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    • Montreal, Quebec, Canada, H3A 2B4
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    • Sherbrooke, Quebec, Canada, J1H 5N4
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  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 1A5
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• Czechia
  • Ostrava-Poruba, Czechia, 708 00
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  • Pardubice, Czechia, 532 03
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  • Plzen - Lochotin, Czechia, 30460
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  • Prague 5, Czechia, 150 00
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  • Praha, Czechia, 12808
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  • Rychnov nad Kneznou, Czechia, 516 01
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  • Teplice, Czechia, 415 29
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  • CZE
    • Olomouc, CZE, Czechia, 775 20
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  • Czech Republic
    • Brno, Czech Republic, Czechia, 656 91
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• Denmark
  • Aarhus, Denmark, DK-8000
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  • Copenhagen, Denmark, DK-2100
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• Egypt
  • Alexandria, Egypt, 21131
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  • Cairo, Egypt
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  • Cairo, Egypt, 11566
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• Estonia
  • Tallinn, Estonia, 10617
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• Finland
  • Helsinki, Finland, 00930
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  • Seinajoki, Finland, 60220
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  • Tampere, Finland, 33100
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  • Turku, Finland, 20520
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• France
  • Bordeaux Cedex, France, F-33076
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  • Bron, France, 69677
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  • CAEN Cedex, France, 14033
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  • Clermont-Ferrand Cedex 1, France, 63003
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  • Dijon, France, 21034
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  • Lille Cedex, France, 59037
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  • Marseille cedex 05, France, 13385
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  • Montpellier, France, 34295
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  • Nice Cedex 1, France, 06602
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  • Paris Cedex 13, France, 75651
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  • Poissy, France, 78303
    • Novartis Investigative Site
  • Rennes, France, 35043
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  • St Herblain, France, 44800
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  • Strasbourg Cedex, France, 67091
    • Novartis Investigative Site
  • Toulouse cedex 9, France, 31059
    • Novartis Investigative Site
  • Cedex
    • Nancy, Cedex, France, 54035
      • Novartis Investigative Site
• Germany
  • Aachen, Germany, 52062
    • Novartis Investigative Site
  • Aalen, Germany, 73430
    • Novartis Investigative Site
  • Abensberg, Germany, 93326
    • Novartis Investigative Site
  • Achim, Germany, 28832
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  • Alzenau, Germany, 63755
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  • Aschaffenburg, Germany, 63739
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  • Augsburg, Germany, 86179
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  • Bad Honnef, Germany, 53604
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  • Bad Krozingen, Germany, 79189
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  • Bad Mergentheim, Germany, 97980
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  • Bad Neustadt, Germany, 97616
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  • Bamberg, Germany, 96049
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  • Bamberg, Germany, 96052
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  • Bayreuth, Germany, 95445
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  • Berlin, Germany, 10713
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  • Berlin, Germany, 13353
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  • Berlin, Germany, 120999
    • Novartis Investigative Site
  • Berlin, Germany, 12101
    • Novartis Investigative Site
  • Berlin, Germany, 12163
    • Novartis Investigative Site
  • Berlin, Germany, 13347
    • Novartis Investigative Site
  • Berlin, Germany, 10178
    • Novartis Investigative Site
  • Berlin, Germany, 12351
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  • Berlin, Germany, 13507
    • Novartis Investigative Site
  • Berlin, Germany, 10625
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  • Berlin, Germany, 14163
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  • Berlin, Germany, 10785
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  • Berlin, Germany, 13439
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  • Bielefeld, Germany, 33647
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  • Bielefeld, Germany, 33602
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  • Bielefeld, Germany, 33611
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  • Boblingen, Germany, 71032
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  • Bochum, Germany, 44787
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  • Bochum, Germany, 44892
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  • Bochum, Germany, 44789
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  • Bogen, Germany, 94327
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  • Bonn, Germany, 53111
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  • Buchholz, Germany, 21244
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  • Buchholz in der Nordheide, Germany, 21244
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  • Chemnitz, Germany, 09117
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  • Dillingen, Germany, 89407
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  • Dresden, Germany, 01307
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  • Düsseldorf, Germany, 40211
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  • Emden, Germany, 26721
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  • Emmendingen, Germany, 79312
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  • Erbach, Germany, 64711
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  • Erfurt, Germany, 99089
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  • Erlangen, Germany, 91054
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  • Essen, Germany, 45147
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  • Essen, Germany, 45131
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  • Frankfurt, Germany, 60590
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  • Freiburg, Germany, 79106
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  • Greifswald, Germany, 17475
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  • Grevenbroich, Germany, 41515
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  • Hamburg, Germany, 20354
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  • Hamburg, Germany, 20099
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  • Hamburg, Germany, 22083
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  • Hamburg, Germany, 20249
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  • Hannover, Germany, 30625
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  • Hannover, Germany, 30161
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  • Hannover, Germany, 30171
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  • Heidelberg, Germany, 69120
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  • Hennigsdorf, Germany, 16761
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  • Herborn, Germany, 35745
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  • Homburg, Germany, 66421
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  • Ibbenbueren, Germany, 49477
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  • Itzehoe, Germany, 25524
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  • Jena, Germany, 07743
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  • Kaltenkirchen, Germany, 24568
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  • Kassel, Germany, 34121
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  • Koeln, Germany, 51109
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  • Koln, Germany, 50935
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  • Krefeld, Germany, 47805
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  • Landshut, Germany, 84028
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  • Lappersdorf, Germany, 93138
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  • Leipzig, Germany, 04103
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  • Leipzig, Germany, 04275
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  • Lohr am Main, Germany, 79816
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  • Ludwigshafen, Germany, 67063
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  • Magdeburg, Germany, 39120
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  • Mainz, Germany, 55131
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  • Mannheim, Germany, 68159
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  • Marburg, Germany, 35039
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  • Muenchen, Germany, 81377
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  • Muenchen, Germany, 80331
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  • Muenchen, Germany, 80377
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  • Muenster, Germany, 48149
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  • München, Germany, 81829
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  • Nagold, Germany, 72202
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  • Neu-Ulm, Germany, 89231
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  • Neuburg an der Donau, Germany, 86633
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  • Neuruppin, Germany, 16816
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  • Oldenburg, Germany, 26122
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  • Osnabrück, Germany, 49076
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  • Pforzheim, Germany, 75172
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  • Potsdam, Germany, 14471
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  • Prien, Germany, 83209
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  • Rostock, Germany, 18057
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  • Ruelzheim, Germany, 76761
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  • Rüdersdorf, Germany, 15562
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  • Schwarzenbruck, Germany, 90592
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  • Schwendi, Germany, 88477
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  • Siegen, Germany, 57076
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  • Sinsheim, Germany, 74889
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  • Stade, Germany, 21682
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  • Stuttgart, Germany, 70174
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  • Stuttgart, Germany, 70178
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  • Stuttgart, Germany, 70182
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  • Stuttgart, Germany, 70176
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  • Teupitz, Germany, 15755
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  • Trier, Germany, 54292
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  • Tübingen, Germany, 72076
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  • Ulm, Germany, 89081
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  • Ulm, Germany, 89073
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  • Unterhaching, Germany, 82008
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  • Wendlingen, Germany, 73240
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  • Wermsdorf, Germany, 04779
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  • Wiesbaden, Germany, 65191
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  • Wuerzburg, Germany, 97080
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  • Wuppertal, Germany, 42283
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  • Würzburg, Germany, 97070
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  • Baden-Wuerttemberg
    • Ostfildern, Baden-Wuerttemberg, Germany, 73760
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  • Bavaria
    • Munich, Bavaria, Germany, 81241
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    • Regensburg, Bavaria, Germany, 93053
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  • Nordrhein-Westfalen
    • Koeln, Nordrhein-Westfalen, Germany, 50937
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• Greece
  • Athens, Greece, 15123
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  • Athens, Greece, 115 21
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  • Athens, Greece, 11526
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  • Athens, Greece, 106 76
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  • Heraklion Crete, Greece, 711 10
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  • Patras, Greece, 265 00
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  • Thessaloniki, Greece, 57001
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  • Thessaloniki, Greece, GR 54636
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  • Evros
    • Alexandroupolis, Evros, Greece, 681 00
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  • GR
    • Athens, GR, Greece, 115 27
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    • Athens, GR, Greece, 115 25
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    • Thessaloniki, GR, Greece, 570 10
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• Guatemala
  • Guatemala City, Guatemala, 01010
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  • Guatemala City, Guatemala, 01014
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• Hungary
  • Budapest, Hungary, 1145
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  • Budapest, Hungary, 1085
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  • Budapest, Hungary, 1076
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  • Budapest, Hungary, 1115
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  • Debrecen, Hungary, 4032
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  • Gyor, Hungary, 9024
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  • Miskolc, Hungary, 3526
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  • Pecs, Hungary, 7623
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  • Szeged, Hungary, 6725
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  • Szekesfehervar, Hungary, H-8000
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  • Veszprem, Hungary, H 8200
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  • HUN
    • Budapest, HUN, Hungary, 1204
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• Ireland
  • Dublin, Ireland, DUBLIN 9
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  • Dublin 4, Ireland, D04 T6F
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• Israel
  • Ashkelon, Israel, 78278
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  • Haifa, Israel, 3436212
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  • Ramat Gan, Israel, 52621
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  • Sefad, Israel, 13100
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• Italy
  • Napoli, Italy, 80131
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  • Napoli, Italy, 80132
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  • Napoli, Italy, 80138
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  • AT
    • Asti, AT, Italy, 14100
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  • BA
    • Acquaviva delle Fonti, BA, Italy, 70021
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  • BG
    • Bergamo, BG, Italy, 24127
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  • BO
    • Bologna, BO, Italy, 40139
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  • BS
    • Montichiari, BS, Italy, 25018
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  • CA
    • Cagliari, CA, Italy, 09126
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  • CH
    • Chieti, CH, Italy, 66100
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  • CT
    • Catania, CT, Italy, 95123
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    • Catania, CT, Italy, 95122
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  • FE
    • Cona, FE, Italy, 44100
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  • FG
    • Foggia, FG, Italy, 71100
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  • FI
    • Firenze, FI, Italy, 50134
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  • GE
    • Genova, GE, Italy, 16132
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  • IS
    • Pozzilli, IS, Italy, 86077
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  • Lazio
    • Roma, Lazio, Italy, 00168
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  • MI
    • Milano, MI, Italy, 20132
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    • Milano, MI, Italy, 20122
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  • PA
    • Palermo, PA, Italy, 90146
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  • PR
    • Fidenza, PR, Italy, 43036
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  • PV
    • Pavia, PV, Italy, 27100
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  • RA
    • Ravenna, RA, Italy, 48100
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  • RM
    • Roma, RM, Italy, 00161
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    • Roma, RM, Italy, 00133
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    • Roma, RM, Italy, 00189
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    • Roma, RM, Italy, 00135
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  • SI
    • Siena, SI, Italy, 53100
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  • TO
    • Orbassano, TO, Italy, 10043
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  • UD
    • Udine, UD, Italy, 33100
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  • VA
    • Gallarate, VA, Italy, 21013
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  • VI
    • Vicenza, VI, Italy, 36100
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  • VR
    • Verona, VR, Italy, 37134
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  • VT
    • Viterbo, VT, Italy, 01100
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• Jordan
  • Irbid, Jordan, 22110
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• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
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  • Seoul, Korea, Republic of, 03722
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  • Korea
    • Gyeonggi do, Korea, Korea, Republic of, 10408
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• Malaysia
  • Kuala Lumpur, Malaysia, 59100
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  • Wilayah Persekutuan
    • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50586
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• Netherlands
  • Amsterdam, Netherlands, 1081 HV
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  • Amsterdam, Netherlands, 1061 AE
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  • Blaricum, Netherlands, 1261 AN
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  • Enschede, Netherlands, 7513 ER
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  • Gouda, Netherlands, 2803 HH
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  • Nieuwegein, Netherlands
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  • Nijmegen, Netherlands, 6525 GC
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  • Rotterdam, Netherlands, 3015 CE
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  • Sittard-Geleen, Netherlands, 6162 BG
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  • Tilburg, Netherlands, 5022 GC
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  • CK
    • Breda, CK, Netherlands, 4818
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• Norway
  • Lillehammer, Norway, 2629
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  • Molde, Norway, 6412
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  • Stavanger, Norway, 4068
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• Panama
  • Panama City, Panama
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  • Panama City, Panama, 0801
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• Peru
  • Callao
    • La Perla, Callao, Peru, 04
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  • Lima
    • Jesus Maria, Lima, Peru, 11
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    • San Isidro, Lima, Peru, 27
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• Poland
  • Bialystok, Poland, 15-276
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  • Bialystok, Poland, 15-420
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  • Bydgoszcz, Poland, 85 681
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  • Gdansk, Poland, 80-803
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  • Katowice, Poland, 40-648
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  • Katowice, Poland, 40 571
    • Novartis Investigative Site
  • Lodz, Poland, 90 324
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  • Poznan, Poland, 60-355
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  • Warszawa, Poland, 02-097
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  • Warszawa, Poland, 02-507
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  • Warszawa, Poland, 04141
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  • Warszawa, Poland, 02-957
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• Portugal
  • Amadora, Portugal, 2720-276
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  • Coimbra, Portugal, 3000075
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  • Lisboa, Portugal, 1150 314
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  • Porto, Portugal, 4099-001
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  • Porto, Portugal, 4200 319
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  • Setubal, Portugal, 2910-446
    • Novartis Investigative Site
• Romania
  • Bucharest, Romania, 050098
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  • Bucharest, Romania, 010825
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  • Bucharest, Romania, 011461
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  • Craiova, Romania, 200620
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  • Targu Mures, Romania, 540136
    • Novartis Investigative Site
• Russian Federation
  • Ekaterinburg, Russian Federation, 620109
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  • Kazan, Russian Federation, 420021
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  • Kazan, Russian Federation, 420097
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  • Moscow, Russian Federation, 121359
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  • Moscow, Russian Federation, 127018
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  • Moscow, Russian Federation, 101990
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  • Moscow, Russian Federation, 125367
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  • Nizhny Novgorod, Russian Federation, 603018
    • Novartis Investigative Site
  • Nizhny Novgorod, Russian Federation, 603155
    • Novartis Investigative Site
  • Saint Petersburg, Russian Federation, 194044
    • Novartis Investigative Site
  • Smolensk, Russian Federation, 214019
    • Novartis Investigative Site
  • St. Petersburg, Russian Federation, 197376
    • Novartis Investigative Site
  • St. Petersburg, Russian Federation, 194291
    • Novartis Investigative Site
  • Samara Region
    • Samara, Samara Region, Russian Federation, 443095
      • Novartis Investigative Site
• Slovakia
  • Bratislava, Slovakia, 826 06
    • Novartis Investigative Site
  • Bratislava, Slovakia, 813 69
    • Novartis Investigative Site
  • Martin, Slovakia, 036 59
    • Novartis Investigative Site
  • Trnava, Slovakia, 917 75
    • Novartis Investigative Site
  • Slovak Republic
    • Bratislava, Slovak Republic, Slovakia, 84103
      • Novartis Investigative Site
• South Africa
  • Cape Town, South Africa, 7925
    • Novartis Investigative Site
  • Durban, South Africa
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  • Rosebank, South Africa, 2196
    • Novartis Investigative Site
• Spain
  • Barcelona, Spain, 08041
    • Novartis Investigative Site
  • Madrid, Spain, 28034
    • Novartis Investigative Site
  • Madrid, Spain, 28046
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  • Madrid, Spain, 28040
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  • Madrid, Spain, 28222
    • Novartis Investigative Site
  • Santa Cruz de Tenerife, Spain, 38009
    • Novartis Investigative Site
  • Andalucia
    • Malaga, Andalucia, Spain, 29010
      • Novartis Investigative Site
    • Sevilla, Andalucia, Spain, 41009
      • Novartis Investigative Site
  • Catalunya
    • Barcelona, Catalunya, Spain, 08035
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    • Barcelona, Catalunya, Spain, 08036
      • Novartis Investigative Site
    • L Hospitalet De Llobregat, Catalunya, Spain, 08907
      • Novartis Investigative Site
  • Comunidad Valenciana
    • Valencia, Comunidad Valenciana, Spain, 46026
      • Novartis Investigative Site
    • Valencia, Comunidad Valenciana, Spain, 46010
      • Novartis Investigative Site
  • Galicia
    • Santiago de Compostela, Galicia, Spain, 15706
      • Novartis Investigative Site
  • Pais Vasco
    • Bilbao, Pais Vasco, Spain, 48013
      • Novartis Investigative Site
    • San Sebastian, Pais Vasco, Spain, 20080
      • Novartis Investigative Site
• Sweden
  • Goeteborg, Sweden, 413 45
    • Novartis Investigative Site
  • Linkoping, Sweden, SE 581 85
    • Novartis Investigative Site
  • Stockholm, Sweden, 14186
    • Novartis Investigative Site
  • Stockholm, Sweden, 102 35
    • Novartis Investigative Site
  • Umea, Sweden, 901 85
    • Novartis Investigative Site
• Switzerland
  • Aarau, Switzerland, 5001
    • Novartis Investigative Site
  • Basel, Switzerland, 4031
    • Novartis Investigative Site
  • Carouge, Switzerland, 1227
    • Novartis Investigative Site
  • Lausanne, Switzerland, 1011
    • Novartis Investigative Site
  • Lugano, Switzerland, 6900
    • Novartis Investigative Site
  • St Gallen, Switzerland, 9007
    • Novartis Investigative Site
  • Zuerich, Switzerland, 8091
    • Novartis Investigative Site
• Turkey
  • Ankara, Turkey, 06100
    • Novartis Investigative Site
  • Ankara, Turkey, 06500
    • Novartis Investigative Site
  • Antalya, Turkey, 07070
    • Novartis Investigative Site
  • Gaziantep, Turkey, 27310
    • Novartis Investigative Site
  • Haseki / Istanbul, Turkey, 34096
    • Novartis Investigative Site
  • Istanbul, Turkey, 34093
    • Novartis Investigative Site
  • Istanbul, Turkey, 34722
    • Novartis Investigative Site
  • Istanbul, Turkey, 34147
    • Novartis Investigative Site
  • Izmir, Turkey, 35040
    • Novartis Investigative Site
  • Izmir, Turkey, 35340
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  • Mersin, Turkey, 33079
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  • Samsun, Turkey, 55139
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  • Trabzon, Turkey, 61080
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  • Yenisehir / Izmir, Turkey
    • Novartis Investigative Site
  • TUR
    • Istanbul, TUR, Turkey, 34098
      • Novartis Investigative Site
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • Novartis Investigative Site
  • Bristol, United Kingdom, BS10 5NB
    • Novartis Investigative Site
  • Dundee, United Kingdom, DD1 9SY
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  • Edinburgh, United Kingdom, EH4 2XU
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  • Essex, United Kingdom, RM7 0BE
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  • Great Yarmouth, United Kingdom, NR31 6LA
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  • Liverpool, United Kingdom, L9 7LJ
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  • London, United Kingdom, SW17 0QT
    • Novartis Investigative Site
  • London, United Kingdom, W8 6RF
    • Novartis Investigative Site
  • London, United Kingdom, SE22 8PT
    • Novartis Investigative Site
  • Middlesbrough, United Kingdom, TS4 3BW
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  • Newcastle Upon Tyne, United Kingdom, NE1 4LP
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  • Northampton, United Kingdom, NN1 5BD
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  • Nottingham, United Kingdom, NG7 2UH
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  • Poole, United Kingdom, BH15 2JB
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  • Swindon, United Kingdom, SN3 6BB
    • Novartis Investigative Site
  • Cornwall
    • Truro, Cornwall, United Kingdom, TR1 3LJ
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  • East Sussex
    • Brighton, East Sussex, United Kingdom, BN2 5BE
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  • Manchester
    • Salford, Manchester, United Kingdom, M6 8HD
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  • Oxfordshire
    • Headington, Oxfordshire, United Kingdom, OX3 9DU
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  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S10 2JF
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  • Staffordshire
    • Stoke on Trent, Staffordshire, United Kingdom, ST46QG
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• United States
  • Alabama
    • Cullman, Alabama, United States, 35058
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  • California
    • Oceanside, California, United States, 92056
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    • Sacramento, California, United States, 95817
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    • San Francisco, California, United States, 94143
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  • District of Columbia
    • Washington, District of Columbia, United States, 20007
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  • Florida
    • Jacksonville, Florida, United States, 32209
      • Novartis Investigative Site
    • Maitland, Florida, United States, 32751
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    • Miami, Florida, United States, 33136
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    • Sunrise, Florida, United States, 33351
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    • Tallahassee, Florida, United States, 32308
      • Novartis Investigative Site
    • Tampa, Florida, United States, 33609
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    • Vero Beach, Florida, United States, 32960
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  • Georgia
    • Atlanta, Georgia, United States, 30327
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  • Kansas
    • Kansas City, Kansas, United States, 66160
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    • Lenexa, Kansas, United States, 66212
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  • Maryland
    • Baltimore, Maryland, United States, 21201
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    • Baltimore, Maryland, United States, 21287
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  • Missouri
    • Kansas City, Missouri, United States, 64111
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  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
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  • New Mexico
    • Albuquerque, New Mexico, United States, 87131-0001
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  • New York
    • New York, New York, United States, 10021
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  • North Carolina
    • Durham, North Carolina, United States, 27710
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    • Raleigh, North Carolina, United States, 27607
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  • Ohio
    • Toledo, Ohio, United States, 43614
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  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
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    • Tulsa, Oklahoma, United States, 74136
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  • Oregon
    • Tualatin, Oregon, United States, 97062
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  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
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  • Tennessee
    • Bristol, Tennessee, United States, 37620
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    • Nashville, Tennessee, United States, 37212
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  • Texas
    • San Antonio, Texas, United States, 78229
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  • Vermont
    • Burlington, Vermont, United States, 05401
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  • Virginia
    • Charlottesville, Virginia, United States, 22904
      • Novartis Investigative Site
  • Washington
    • Seattle, Washington, United States, 98122
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

- Patients who have completed selected ongoing or planned trials with FTY720.

Key Exclusion Criteria:

• Premature permanent discontinuation of a previous fingolimod study.
• Pregnant or nursing (lactating) women.
• Women of child-bearing potential, UNLESS they are using two birth control methods, at least 1 of which must be hormonal contraception, tubal sterilization, partner's vasectomy or intrauterine device.
• Chronic disease of the immune system, other than multiple sclerosis, which may require immunosuppressive treatment.
• Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c > 8%.
• Active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
• Previous treatment with cladribine, cyclophosphamide or mitoxantrone.
• Treatment with immunoglobulins and/or monoclonal antibodies (including Natalizumab) in the past 3 months during the previous fingolimod study:

• Any of the following cardiovascular conditions that have developed during the previous fingolimod study:

  • Myocardial infarction within the past 6 months prior to entry in the extension study or with current unstable ischemic heart disease;
  • Cardiac failure (Class III, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator;
  • Arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibutilide, azimilide, dofetilide)
  • History or presence of a third degree AV block
  • Proven history of sick sinus syndrome or sino-atrial heart block
  • Known history of angina pectoris due to coronary spasm or Raynaud's phenomenon

• Any of the following pulmonary conditions during the previous fingolimod study:

  • Severe respiratory disease or pulmonary fibrosis diagnosed (during the previous fingolimod study)
  • Active tuberculosis
• Alcohol abuse, chronic liver disease during the previous fingolimod study.

The patient must have participated in a previous fingolimod trial to be eligible to participate in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fingolimod 0.5 mg/day; Open-label fingolimod 0.5 mg, taken orally once daily	Drug: Fingolimod; 0.5 mg/day; Other Names: FTY720

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parts I and II: Number of Participants With Adverse Events, Serious Adverse Event, and Death	Analysis of absolute and relative frequencies for Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that Fingolimod 0.5 mg/day is safe in patients with relapsing forms of Multiple Sclerosis (MS) through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.	Baseline (Part I) to Month 6 Follow-up (Part II), up to 8 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part I: Aggregate Annualized Relapse Rates (ARR) From First Dose of Fingolimod	Annualized relapse rate (ARR) is defined as the number of all relapses (including both confirmed and unconfirmed relapses) experienced during a specific period of time adjusted to a one-year period. ARR is calculated as follows: (total number of all relapses) / (total number of days in the study for all patients for that specific period of time) x 365.25. Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed.	Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)
Part I: Number of Participants With Relapses (Confirmed and Unconfirmed) From First Dose of Fingolimod	A relapse is defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5°C) or infection. In Study Part One, a relapse must be confirmed by an Expanded Disability Status Scale (EDSS) certified Physician within 7 days of the onset of symptoms. A relapse is confirmed when it is accompanied by an increase of at least half a step (0.5) on the EDSS or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed.	Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)
Part I: Annualized Rates of New or Newly Enlarging T2 Lesions (ARneT2) Compared With First Dose of Fingolimod	Annualized rate of new/newly enlarging T2 lesions (ARneT2) is defined as the number of new or newly enlarging T2 lesions experienced during a specific period of time adjusted to a one-year period. ARneT2 was calculated as follows: (total number of new/newly enlarging T2 lesions) / (total number of days in the study for all patients for that specific period of time) x 365.25.Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed.	Month 0 (Core Baseline) to End of Study (an average of Month 156)
Part I: Change From First Dose of Fingolimod in Total T2 Lesions Volume	Total volume of T2 lesions was summarized by presenting descriptive statistics for change from first dose of fingolimod baseline values by visit.	Month 3 to End of Study (Study Completion Visit)
Part I: Change From First Dose of Fingolimod in Total T1 Hypointense Lesions Volume	T1 hypointense lesion (black hole) volume was summarized by presenting descriptive statistics for change from first dose of fingolimod baseline values by visit.	Month 3 to End of Study (Study Completion Visit)
Part I: Percent Brain Volume Change (PBVC) Relative to First Dose of Fingolimod	Descriptive statistics on percent brain volume change from first dose of fingolimod baseline were presented by visit. A negative change from baseline indicates improvement.	Month 3 to Month 156
Part I: Annualized Rate of Brain Atrophy (ARBA) Relative to First Dose of Fingolimod	The annualized rate of brain volume change is an "averaged annual percentage change" in brain volume. ARBA was calculated as: ARBA = [(SIENA/100+1) ^ (365.25/#days)-1]*100 where SIENA=(Vk/V0-1)*100 and Vk is the brain volume at time k, V0 is the brain volume at time 0 and k is the total number of days in the study for all patients for that specific period of time) × 365.25. Only descriptive analysis performed.	Month 3 to Month 156
Part I: Number of Participants With Confirmed 6-month Disability Progression After First Dose of Fingolimod	Disability progression was defined based on an increase in the EDSS score by 1.5 point for patients with a first dose of fingolimod (FDF) baseline EDSS score of 0, 1 point for patients with FDF baseline EDSS of >=1 and <=5.5, and by 0.5 points for patients with an FDF baseline EDSS>5.5, confirmed after 6 months and all intermediate EDSS assessments. A 6-month confirmed disability progression was defined as a 6-month sustained increase from the reference (potential onset of progression) value in the EDSS scores. i.e., every EDSS score (scheduled or unscheduled) within a 6-month duration after the first progression should meet the progression criteria as specified above. The confirmation could only happen at a scheduled visit and in the absence of a relapse. Only descriptive analysis performed.	Month 12 to Month 156
Part I: Number of Participants With Categorized Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS) Overall Score	The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's overall score is categorized as Improvement, Stable or Deterioration. If baseline EDSS score is <=5, improvement is indicated by an EDSS score change of <= -1, stable is indicated by an EDSS score change of > -1 and <= 0.5, deterioration is indicated by an EDSS score change of > 0.5; if baseline EDSS score is > 5, improvement is indicated by an EDSS score change of <= -0.5, stable is indicated by an EDSS score change of > -0.5 and <= 0, deterioration is indicated by an EDSS score change of > 0. Only descriptive analysis performed.	Month 3 to Month 6 Follow-up
Part I: Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS)	The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's overall score is determined between 0 to 10. A negative change from baseline indicates improvement. Only descriptive analysis performed.	Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• Cohen JA, Tenenbaum N, Bhatt A, Zhang Y, Kappos L. Extended treatment with fingolimod for relapsing multiple sclerosis: the 14-year LONGTERMS study results. Ther Adv Neurol Disord. 2019 Sep 25;12:1756286419878324. doi: 10.1177/1756286419878324. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 13, 2010
• Primary Completion (ACTUAL): October 19, 2018
• Study Completion (ACTUAL): October 19, 2018

Study Registration Dates

• First Submitted: September 10, 2010
• First Submitted That Met QC Criteria: September 13, 2010
• First Posted (ESTIMATE): September 14, 2010

Study Record Updates

• Last Update Posted (ACTUAL): April 21, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Efficacy; Fingolimod; FTY720; Relapsing forms of MS
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Sphingosine 1 Phosphate Receptor Modulators; Fingolimod Hydrochloride
• Other Study ID Numbers: CFTY720D2399; 2010-020515-37 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No