AzTrials
AzTrials

Relapsing Forms of Multiple SclerosisPhase 3NCT01201356

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

A Phase 3 study testing Fingolimod in people with Relapsing Forms of Multiple Sclerosis, run by Novartis Pharmaceuticals at 458 sites in 38 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsing Forms of Multiple Sclerosis
What is being tested?
Fingolimod
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,125 participants
Where
458 sitesin 38 countries
Study dates
13 Sep 2010to 19 Oct 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 20Show fewer
  • 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.

Trial locations and contacts

458 sites in 38 countries.

458 sites in 38 countries

Germany124 sites

  • Novartis Investigative Site

    Aachen, 52062

  • Novartis Investigative Site

    Aalen, 73430

  • Novartis Investigative Site

    Abensberg, 93326

  • Novartis Investigative Site

    Achim, 28832

  • Novartis Investigative Site

    Alzenau in Unterfranken, 63755

  • Novartis Investigative Site

    Aschaffenburg, 63739

  • Novartis Investigative Site

    Augsburg, 86179

  • Novartis Investigative Site

    Bad Honnef, 53604

  • Novartis Investigative Site

    Bad Krozingen, 79189

  • Novartis Investigative Site

    Bad Mergentheim, 97980

  • Novartis Investigative Site

    Bad Neustadt an der Saale, 97616

  • Novartis Investigative Site

    Bamberg, 96049

  • Novartis Investigative Site

    Bamberg, 96052

  • Novartis Investigative Site

    Bayreuth, 95445

  • Novartis Investigative Site

    Berlin, 10178

  • Novartis Investigative Site

    Berlin, 10625

  • Novartis Investigative Site

    Berlin, 10713

  • Novartis Investigative Site

    Berlin, 10785

  • Novartis Investigative Site

    Berlin, 120999

  • Novartis Investigative Site

    Berlin, 12101

  • Novartis Investigative Site

    Berlin, 12163

  • Novartis Investigative Site

    Berlin, 12351

  • Novartis Investigative Site

    Berlin, 13347

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Berlin, 13439

  • Novartis Investigative Site

    Berlin, 13507

  • Novartis Investigative Site

    Berlin, 14163

  • Novartis Investigative Site

    Bielefeld, 33602

  • Novartis Investigative Site

    Bielefeld, 33611

  • Novartis Investigative Site

    Bielefeld, 33647

  • Novartis Investigative Site

    Böblingen, 71032

  • Novartis Investigative Site

    Bochum, 44787

  • Novartis Investigative Site

    Bochum, 44789

  • Novartis Investigative Site

    Bochum, 44892

  • Novartis Investigative Site

    Bogen, 94327

  • Novartis Investigative Site

    Bonn, 53111

  • Novartis Investigative Site

    Buchholz, 21244

  • Novartis Investigative Site

    Buchholz in der Nordheide, 21244

  • Novartis Investigative Site

    Chemnitz, 09117

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50937

  • Novartis Investigative Site

    Cologne, 50935

  • Novartis Investigative Site

    Cologne, 51109

  • Novartis Investigative Site

    Dillingen, 89407

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Düsseldorf, 40211

  • Novartis Investigative Site

    Emden, 26721

  • Novartis Investigative Site

    Emmendingen, 79312

  • Novartis Investigative Site

    Erbach im Odenwald, 64711

  • Novartis Investigative Site

    Erfurt, 99089

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Essen, 45131

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Frankfurt, 60590

  • Novartis Investigative Site

    Freiburg im Breisgau, 79106

  • Novartis Investigative Site

    Greifswald, 17475

  • Novartis Investigative Site

    Grevenbroich, 41515

  • Novartis Investigative Site

    Hamburg, 20099

  • Novartis Investigative Site

    Hamburg, 20249

  • Novartis Investigative Site

    Hamburg, 20354

  • Novartis Investigative Site

    Hamburg, 22083

  • Novartis Investigative Site

    Hanover, 30161

  • Novartis Investigative Site

    Hanover, 30171

  • Novartis Investigative Site

    Hanover, 30625

  • Novartis Investigative Site

    Heidelberg, 69120

  • Novartis Investigative Site

    Hennigsdorf, 16761

  • Novartis Investigative Site

    Herborn, 35745

  • Novartis Investigative Site

    Homburg, 66421

  • Novartis Investigative Site

    Ibbenbueren, 49477

  • Novartis Investigative Site

    Itzehoe, 25524

  • Novartis Investigative Site

    Jena, 07743

  • Novartis Investigative Site

    Kaltenkirchen, 24568

  • Novartis Investigative Site

    Kassel, 34121

  • Novartis Investigative Site

    Krefeld, 47805

  • Novartis Investigative Site

    Landshut, 84028

  • Novartis Investigative Site

    Lappersdorf, 93138

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Leipzig, 04275

  • Novartis Investigative Site

    Lohr a. Main, 79816

  • Novartis Investigative Site

    Ludwigshafen, 67063

  • Novartis Investigative Site

    Magdeburg, 39120

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Mannheim, 68159

  • Novartis Investigative Site

    Marburg, 35039

  • Novartis Investigative Site

    München, 80331

  • Novartis Investigative Site

    München, 80377

  • Novartis Investigative Site

    München, 81377

  • Novartis Investigative Site

    München, 81829

  • Novartis Investigative Site

    Munich, Bavaria, 81241

  • Novartis Investigative Site

    Münster, 48149

  • Novartis Investigative Site

    Nagold, 72202

  • Novartis Investigative Site

    Neu-Ulm, 89231

  • Novartis Investigative Site

    Neuburg an der Donau, 86633

  • Novartis Investigative Site

    Neuruppin, 16816

  • Novartis Investigative Site

    Oldenburg, 26122

  • Novartis Investigative Site

    Osnabrück, 49076

  • Novartis Investigative Site

    Ostfildern, Baden-Wurttemberg, 73760

  • Novartis Investigative Site

    Pforzheim, 75172

  • Novartis Investigative Site

    Potsdam, 14471

  • Novartis Investigative Site

    Prien am Chiemsee, 83209

  • Novartis Investigative Site

    Regensburg, Bavaria, 93053

  • Novartis Investigative Site

    Rostock, 18057

  • Novartis Investigative Site

    Rüdersdorf, 15562

  • Novartis Investigative Site

    Rülzheim, 76761

  • Novartis Investigative Site

    Schwarzenbruck, 90592

  • Novartis Investigative Site

    Schwendi, 88477

  • Novartis Investigative Site

    Siegen, 57076

  • Novartis Investigative Site

    Sinsheim, 74889

  • Novartis Investigative Site

    Stade, 21682

  • Novartis Investigative Site

    Stuttgart, 70174

  • Novartis Investigative Site

    Stuttgart, 70176

  • Novartis Investigative Site

    Stuttgart, 70178

  • Novartis Investigative Site

    Stuttgart, 70182

  • Novartis Investigative Site

    Teupitz, 15755

  • Novartis Investigative Site

    Trier, 54292

  • Novartis Investigative Site

    Tübingen, 72076

  • Novartis Investigative Site

    Ulm, 89073

  • Novartis Investigative Site

    Ulm, 89081

  • Novartis Investigative Site

    Unterhaching, 82008

  • Novartis Investigative Site

    Wendlingen, 73240

  • Novartis Investigative Site

    Wermsdorf, 04779

  • Novartis Investigative Site

    Wiesbaden, 65191

  • Novartis Investigative Site

    Wuppertal, 42283

  • Novartis Investigative Site

    Würzburg, 97070

  • Novartis Investigative Site

    Würzburg, 97080

Other trials in Germany

Italy35 sites

  • Novartis Investigative Site

    Acquaviva delle Fonti, BA, 70021

  • Novartis Investigative Site

    Asti, AT, 14100

  • Novartis Investigative Site

    Bergamo, BG, 24127

  • Novartis Investigative Site

    Bologna, BO, 40139

  • Novartis Investigative Site

    Cagliari, CA, 09126

  • Novartis Investigative Site

    Catania, CT, 95122

  • Novartis Investigative Site

    Catania, CT, 95123

  • Novartis Investigative Site

    Chieti, CH, 66100

  • Novartis Investigative Site

    Cona, FE, 44100

  • Novartis Investigative Site

    Fidenza, PR, 43036

  • Novartis Investigative Site

    Florence, FI, 50134

  • Novartis Investigative Site

    Foggia, FG, 71100

  • Novartis Investigative Site

    Gallarate, VA, 21013

  • Novartis Investigative Site

    Genova, GE, 16132

  • Novartis Investigative Site

    Milan, MI, 20122

  • Novartis Investigative Site

    Milan, MI, 20132

  • Novartis Investigative Site

    Montichiari, BS, 25018

  • Novartis Investigative Site

    Naples, 80131

  • Novartis Investigative Site

    Naples, 80132

  • Novartis Investigative Site

    Naples, 80138

  • Novartis Investigative Site

    Orbassano, TO, 10043

  • Novartis Investigative Site

    Palermo, PA, 90146

  • Novartis Investigative Site

    Pavia, PV, 27100

  • Novartis Investigative Site

    Pozzilli, IS, 86077

  • Novartis Investigative Site

    Ravenna, RA, 48100

  • Novartis Investigative Site

    Roma, RM, 00133

  • Novartis Investigative Site

    Roma, RM, 00135

  • Novartis Investigative Site

    Roma, RM, 00161

  • Novartis Investigative Site

    Roma, RM, 00189

  • Novartis Investigative Site

    Rome, Lazio, 00168

  • Novartis Investigative Site

    Siena, SI, 53100

  • Novartis Investigative Site

    Udine, UD, 33100

  • Novartis Investigative Site

    Verona, VR, 37134

  • Novartis Investigative Site

    Vicenza, VI, 36100

  • Novartis Investigative Site

    Viterbo, VT, 01100

Other trials in Italy

United States34 sites

  • Novartis Investigative Site

    Albuquerque, New Mexico, 87131-0001

  • Novartis Investigative Site

    Atlanta, Georgia, 30327

  • Novartis Investigative Site

    Baltimore, Maryland, 21201

  • Novartis Investigative Site

    Baltimore, Maryland, 21287

  • Novartis Investigative Site

    Bristol, Tennessee, 37620

  • Novartis Investigative Site

    Burlington, Vermont, 05401

  • Novartis Investigative Site

    Charlottesville, Virginia, 22904

  • Novartis Investigative Site

    Cullman, Alabama, 35058

  • Novartis Investigative Site

    Durham, North Carolina, 27710

  • Novartis Investigative Site

    Jacksonville, Florida, 32209

  • Novartis Investigative Site

    Kansas City, Kansas, 66160

  • Novartis Investigative Site

    Kansas City, Missouri, 64111

  • Novartis Investigative Site

    Lebanon, New Hampshire, 03756

  • Novartis Investigative Site

    Lenexa, Kansas, 66212

  • Novartis Investigative Site

    Maitland, Florida, 32751

  • Novartis Investigative Site

    Miami, Florida, 33136

  • Novartis Investigative Site

    Nashville, Tennessee, 37212

  • Novartis Investigative Site

    New York, New York, 10021

  • Novartis Investigative Site

    Oceanside, California, 92056

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73104

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania, 15213

  • Novartis Investigative Site

    Raleigh, North Carolina, 27607

  • Novartis Investigative Site

    Sacramento, California, 95817

  • Novartis Investigative Site

    San Antonio, Texas, 78229

  • Novartis Investigative Site

    San Francisco, California, 94143

  • Novartis Investigative Site

    Seattle, Washington, 98122

  • Novartis Investigative Site

    Sunrise, Florida, 33351

  • Novartis Investigative Site

    Tallahassee, Florida, 32308

  • Novartis Investigative Site

    Tampa, Florida, 33609

  • Novartis Investigative Site

    Toledo, Ohio, 43614

  • Novartis Investigative Site

    Tualatin, Oregon, 97062

  • Novartis Investigative Site

    Tulsa, Oklahoma, 74136

  • Novartis Investigative Site

    Vero Beach, Florida, 32960

  • Novartis Investigative Site

    Washington D.C., District of Columbia, 20007

Other trials in United States

United Kingdom22 sites

  • Novartis Investigative Site

    Birmingham, B15 2TH

  • Novartis Investigative Site

    Brighton, East Sussex, BN2 5BE

  • Novartis Investigative Site

    Bristol, BS10 5NB

  • Novartis Investigative Site

    Dundee, DD1 9SY

  • Novartis Investigative Site

    Edinburgh, EH4 2XU

  • Novartis Investigative Site

    Essex, RM7 0BE

  • Novartis Investigative Site

    Great Yarmouth, NR31 6LA

  • Novartis Investigative Site

    Headington, Oxfordshire, OX3 9DU

  • Novartis Investigative Site

    Liverpool, L9 7LJ

  • Novartis Investigative Site

    London, SE22 8PT

  • Novartis Investigative Site

    London, SW17 0QT

  • Novartis Investigative Site

    London, W8 6RF

  • Novartis Investigative Site

    Middlesbrough, TS4 3BW

  • Novartis Investigative Site

    Newcastle upon Tyne, NE1 4LP

  • Novartis Investigative Site

    Northampton, NN1 5BD

  • Novartis Investigative Site

    Nottingham, NG7 2UH

  • Novartis Investigative Site

    Poole, BH15 2JB

  • Novartis Investigative Site

    Salford, Manchester, M6 8HD

  • Novartis Investigative Site

    Sheffield, South Yorkshire, S10 2JF

  • Novartis Investigative Site

    Stoke-on-Trent, Staffordshire, ST46QG

  • Novartis Investigative Site

    Swindon, SN3 6BB

  • Novartis Investigative Site

    Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

Canada17 sites

  • Novartis Investigative Site

    Burnaby, British Columbia, V5G 2X6

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 2G3

  • Novartis Investigative Site

    Greenfield Park, Quebec, J4V 2J2

  • Novartis Investigative Site

    Halifax, Nova Scotia, B3H 2Y9

  • Novartis Investigative Site

    Kingston, Ontario, K7L 2V7

  • Novartis Investigative Site

    London, Ontario, N6A 5A5

  • Novartis Investigative Site

    Montreal, Quebec, H1T 2M4

  • Novartis Investigative Site

    Montreal, Quebec, H2L 4M1

  • Novartis Investigative Site

    Montreal, Quebec, H3A 2B4

  • Novartis Investigative Site

    Nepean, Ontario, K2G 6E2

  • Novartis Investigative Site

    Ottawa, Ontario, K1H 8L6

  • Novartis Investigative Site

    Québec, Quebec, G1J 1Z4

  • Novartis Investigative Site

    Regina, Saskatchewan, S4T 1A5

  • Novartis Investigative Site

    Sherbrooke, Quebec, J1H 5N4

  • Novartis Investigative Site

    Toronto, Ontario, M5B 1W8

  • Novartis Investigative Site

    Vancouver, British Columbia, V6T 1Z3

  • Novartis Investigative Site

    Victoria, British Columbia, V8R 1J8

Other trials in Canada

France16 sites

  • Novartis Investigative Site

    Bordeaux, F-33076

  • Novartis Investigative Site

    Bron, 69677

  • Novartis Investigative Site

    Caen, 14033

  • Novartis Investigative Site

    Clermont-Ferrand, 63003

  • Novartis Investigative Site

    Dijon, 21034

  • Novartis Investigative Site

    Lille, 59037

  • Novartis Investigative Site

    Marseille, 13385

  • Novartis Investigative Site

    Montpellier, 34295

  • Novartis Investigative Site

    Nancy, Cedex, 54035

  • Novartis Investigative Site

    Nice, 06602

  • Novartis Investigative Site

    Paris, 75651

  • Novartis Investigative Site

    Poissy, 78303

  • Novartis Investigative Site

    Rennes, 35043

  • Novartis Investigative Site

    Saint-Herblain, 44800

  • Novartis Investigative Site

    Strasbourg, 67091

  • Novartis Investigative Site

    Toulouse, 31059

Other trials in France

Spain16 sites

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036

  • Novartis Investigative Site

    Barcelona, 08041

  • Novartis Investigative Site

    Bilbao, Basque Country, 48013

  • Novartis Investigative Site

    Donostia / San Sebastian, Basque Country, 20080

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Catalonia, 08907

  • Novartis Investigative Site

    Madrid, 28034

  • Novartis Investigative Site

    Madrid, 28040

  • Novartis Investigative Site

    Madrid, 28046

  • Novartis Investigative Site

    Madrid, 28222

  • Novartis Investigative Site

    Málaga, Andalusia, 29010

  • Novartis Investigative Site

    Santa Cruz de Tenerife, 38009

  • Novartis Investigative Site

    Santiago de Compostela, Galicia, 15706

  • Novartis Investigative Site

    Seville, Andalusia, 41009

  • Novartis Investigative Site

    Valencia, Valencia, 46010

  • Novartis Investigative Site

    Valencia, Valencia, 46026

Other trials in Spain

Turkey (Türkiye)15 sites

  • Novartis Investigative Site

    Ankara, 06100

  • Novartis Investigative Site

    Ankara, 06500

  • Novartis Investigative Site

    Antalya, 07070

  • Novartis Investigative Site

    Gaziantep, 27310

  • Novartis Investigative Site

    Haseki / Istanbul, 34096

  • Novartis Investigative Site

    Istanbul, TUR, 34098

  • Novartis Investigative Site

    Istanbul, 34093

  • Novartis Investigative Site

    Istanbul, 34147

  • Novartis Investigative Site

    Istanbul, 34722

  • Novartis Investigative Site

    Izmir, 35040

  • Novartis Investigative Site

    Izmir, 35340

  • Novartis Investigative Site

    Mersin, 33079

  • Novartis Investigative Site

    Samsun, 55139

  • Novartis Investigative Site

    Trabzon, 61080

  • Novartis Investigative Site

    Yenisehir / Izmir

Other trials in Turkey (Türkiye)

Russia14 sites

  • Novartis Investigative Site

    Kazan', 420021

  • Novartis Investigative Site

    Kazan', 420097

  • Novartis Investigative Site

    Moscow, 101990

  • Novartis Investigative Site

    Moscow, 121359

  • Novartis Investigative Site

    Moscow, 125367

  • Novartis Investigative Site

    Moscow, 127018

  • Novartis Investigative Site

    Nizhny Novgorod, 603018

  • Novartis Investigative Site

    Nizhny Novgorod, 603155

  • Novartis Investigative Site

    Saint Petersburg, 194044

  • Novartis Investigative Site

    Saint Petersburg, 194291

  • Novartis Investigative Site

    Saint Petersburg, 197376

  • Novartis Investigative Site

    Samara, Samara Oblast, 443095

  • Novartis Investigative Site

    Smolensk, 214019

  • Novartis Investigative Site

    Yekaterinburg, 620109

Other trials in Russia

Belgium13 sites

  • Novartis Investigative Site

    Aalst, 9300

  • Novartis Investigative Site

    Bruges, 8000

  • Novartis Investigative Site

    Brussels, 1070

  • Novartis Investigative Site

    Brussels, 1090

  • Novartis Investigative Site

    Brussels, 1200

  • Novartis Investigative Site

    Charleroi, 6000

  • Novartis Investigative Site

    Fraiture En Condroz, Belgium, 4557

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Melsbroek, 1820

  • Novartis Investigative Site

    Overpelt, 3900

  • Novartis Investigative Site

    Sijsele, 8340

  • Novartis Investigative Site

    Sint-Truiden, 3800

  • Novartis Investigative Site

    Wilrijk, 2610

Other trials in Belgium

Greece12 sites

  • Novartis Investigative Site

    Alexandroupoli, Evros, 681 00

  • Novartis Investigative Site

    Athens, GR, 115 25

  • Novartis Investigative Site

    Athens, GR, 115 27

  • Novartis Investigative Site

    Athens, 106 76

  • Novartis Investigative Site

    Athens, 115 21

  • Novartis Investigative Site

    Athens, 11526

  • Novartis Investigative Site

    Athens, 15123

  • Novartis Investigative Site

    Heraklion Crete, Greece, 711 10

  • Novartis Investigative Site

    Pátrai, 265 00

  • Novartis Investigative Site

    Thessaloniki, GR, 570 10

  • Novartis Investigative Site

    Thessaloniki, 57001

  • Novartis Investigative Site

    Thessaloniki, GR 54636

Other trials in Greece

Hungary12 sites

  • Novartis Investigative Site

    Budapest, HUN, 1204

  • Novartis Investigative Site

    Budapest, 1076

  • Novartis Investigative Site

    Budapest, 1085

  • Novartis Investigative Site

    Budapest, 1115

  • Novartis Investigative Site

    Budapest, 1145

  • Novartis Investigative Site

    Debrecen, 4032

  • Novartis Investigative Site

    Győr, 9024

  • Novartis Investigative Site

    Miskolc, 3526

  • Novartis Investigative Site

    Pécs, 7623

  • Novartis Investigative Site

    Szeged, 6725

  • Novartis Investigative Site

    Székesfehérvár, H-8000

  • Novartis Investigative Site

    Veszprém, H 8200

Other trials in Hungary

Poland12 sites

  • Novartis Investigative Site

    Bialystok, 15-276

  • Novartis Investigative Site

    Bialystok, 15-420

  • Novartis Investigative Site

    Bydgoszcz, 85 681

  • Novartis Investigative Site

    Gdansk, 80-803

  • Novartis Investigative Site

    Katowice, 40 571

  • Novartis Investigative Site

    Katowice, 40-648

  • Novartis Investigative Site

    Lodz, 90 324

  • Novartis Investigative Site

    Poznan, 60-355

  • Novartis Investigative Site

    Warsaw, 02-097

  • Novartis Investigative Site

    Warsaw, 02-507

  • Novartis Investigative Site

    Warsaw, 02-957

  • Novartis Investigative Site

    Warsaw, 04141

Other trials in Poland

Netherlands11 sites

  • Novartis Investigative Site

    Amsterdam, 1061 AE

  • Novartis Investigative Site

    Amsterdam, 1081 HV

  • Novartis Investigative Site

    Blaricum, 1261 AN

  • Novartis Investigative Site

    Breda, CK, 4818

  • Novartis Investigative Site

    Enschede, 7513 ER

  • Novartis Investigative Site

    Gouda, 2803 HH

  • Novartis Investigative Site

    Nieuwegein

  • Novartis Investigative Site

    Nijmegen, 6525 GC

  • Novartis Investigative Site

    Rotterdam, 3015 CE

  • Novartis Investigative Site

    Sittard-Geleen, 6162 BG

  • Novartis Investigative Site

    Tilburg, 5022 GC

Other trials in Netherlands

Argentina10 sites

  • Novartis Investigative Site

    CABA, Buenos Aires, 1425

  • Novartis Investigative Site

    CABA, Buenos Aires, C1181ACH

  • Novartis Investigative Site

    CABA, Buenos Aires, C1428AQK

  • Novartis Investigative Site

    Capital Federal, Buenos Aires, C1192AAW

  • Novartis Investigative Site

    Córdoba, X5004CDT

  • Novartis Investigative Site

    Rosario, Santa Fe Province, 2000

  • Novartis Investigative Site

    Salta, Salta Province, A4406BPF

  • Novartis Investigative Site

    Salta, A4400BKZ

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, 4000

  • Novartis Investigative Site

    Villa Nueva, Mendoza Province, M5507XAD

Other trials in Argentina

Australia10 sites

  • Novartis Investigative Site

    Box Hill, Victoria, 3128

  • Novartis Investigative Site

    Camperdown, New South Wales, 2050

  • Novartis Investigative Site

    Chatswood, New South Wales, 2067

  • Novartis Investigative Site

    Fitzroy, Victoria, 3065

  • Novartis Investigative Site

    Heidelberg, Victoria, 3084

  • Novartis Investigative Site

    Kogarah, New South Wales, 2217

  • Novartis Investigative Site

    Liverpool, New South Wales, 2170

  • Novartis Investigative Site

    North Gosford, New South Wales, 2250

  • Novartis Investigative Site

    Parkville, Victoria, 3050

  • Novartis Investigative Site

    Woodville, South Australia, 5011

Other trials in Australia

Czechia9 sites

  • Novartis Investigative Site

    Brno, Czech Republic, 656 91

  • Novartis Investigative Site

    Olomouc, CZE, 775 20

  • Novartis Investigative Site

    Ostrava-Poruba, 708 00

  • Novartis Investigative Site

    Pardubice, 532 03

  • Novartis Investigative Site

    Plzen - Lochotin, 30460

  • Novartis Investigative Site

    Prague, 12808

  • Novartis Investigative Site

    Prague, 150 00

  • Novartis Investigative Site

    Rychnov nad Kněžnou, 516 01

  • Novartis Investigative Site

    Teplice, 415 29

Other trials in Czechia

Brazil7 sites

  • Novartis Investigative Site

    Campinas, São Paulo, 13083-970

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Novartis Investigative Site

    Ribeirão Preto, São Paulo, 14048-900

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 20270-004

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 21941-913

  • Novartis Investigative Site

    Rio de Janiero, Rio de Janeiro, 20221-161

Other trials in Brazil

Switzerland7 sites

  • Novartis Investigative Site

    Aarau, 5001

  • Novartis Investigative Site

    Basel, 4031

  • Novartis Investigative Site

    Carouge, 1227

  • Novartis Investigative Site

    Lausanne, 1011

  • Novartis Investigative Site

    Lugano, 6900

  • Novartis Investigative Site

    Sankt Gallen, 9007

  • Novartis Investigative Site

    Zurich, 8091

Other trials in Switzerland

Austria6 sites

  • Novartis Investigative Site

    Innsbruck, Tyrol, 6020

  • Novartis Investigative Site

    Linz, A-4020

  • Novartis Investigative Site

    Salzburg, 5020

  • Novartis Investigative Site

    Sankt Pölten, 3100

  • Novartis Investigative Site

    Vienna, 1010

  • Novartis Investigative Site

    Vienna, 1090

Other trials in Austria

Portugal6 sites

  • Novartis Investigative Site

    Amadora, 2720-276

  • Novartis Investigative Site

    Coimbra, 3000075

  • Novartis Investigative Site

    Lisbon, 1150 314

  • Novartis Investigative Site

    Porto, 4099-001

  • Novartis Investigative Site

    Porto, 4200 319

  • Novartis Investigative Site

    Setúbal, 2910-446

Other trials in Portugal

Romania5 sites

  • Novartis Investigative Site

    Bucharest, 010825

  • Novartis Investigative Site

    Bucharest, 011461

  • Novartis Investigative Site

    Bucharest, 050098

  • Novartis Investigative Site

    Craiova, 200620

  • Novartis Investigative Site

    Târgu Mureş, 540136

Other trials in Romania

Slovakia5 sites

  • Novartis Investigative Site

    Bratislava, Slovak Republic, 84103

  • Novartis Investigative Site

    Bratislava, 813 69

  • Novartis Investigative Site

    Bratislava, 826 06

  • Novartis Investigative Site

    Martin, 036 59

  • Novartis Investigative Site

    Trnava, 917 75

Other trials in Slovakia

Sweden5 sites

  • Novartis Investigative Site

    Gothenburg, 413 45

  • Novartis Investigative Site

    Linköping, SE 581 85

  • Novartis Investigative Site

    Stockholm, 102 35

  • Novartis Investigative Site

    Stockholm, 14186

  • Novartis Investigative Site

    Umeå, 901 85

Other trials in Sweden

Finland4 sites

  • Novartis Investigative Site

    Helsinki, 00930

  • Novartis Investigative Site

    Seinäjoki, 60220

  • Novartis Investigative Site

    Tampere, 33100

  • Novartis Investigative Site

    Turku, 20520

Other trials in Finland

Israel4 sites

  • Novartis Investigative Site

    Ashkelon, 78278

  • Novartis Investigative Site

    Haifa, 3436212

  • Novartis Investigative Site

    Ramat Gan, 52621

  • Novartis Investigative Site

    Sefad, 13100

Other trials in Israel

Egypt3 sites

  • Novartis Investigative Site

    Alexandria, 21131

  • Novartis Investigative Site

    Cairo, 11566

  • Novartis Investigative Site

    Cairo

Other trials in Egypt

Norway3 sites

  • Novartis Investigative Site

    Lillehammer, 2629

  • Novartis Investigative Site

    Molde, 6412

  • Novartis Investigative Site

    Stavanger, 4068

Other trials in Norway

Peru3 sites

  • Novartis Investigative Site

    Jesus Maria, Lima region, 11

  • Novartis Investigative Site

    La Perla, Provincia Constitucional del Callao, 04

  • Novartis Investigative Site

    San Isidro, Lima region, 27

Other trials in Peru

South Africa3 sites

  • Novartis Investigative Site

    Cape Town, 7925

  • Novartis Investigative Site

    Durban

  • Novartis Investigative Site

    Rosebank, 2196

Other trials in South Africa

South Korea3 sites

  • Novartis Investigative Site

    Gyeonggi-do, Korea, 10408

  • Novartis Investigative Site

    Seoul, 03722

  • Novartis Investigative Site

    Seoul, 06351

Other trials in South Korea

Denmark2 sites

  • Novartis Investigative Site

    Aarhus, DK-8000

  • Novartis Investigative Site

    Copenhagen, DK-2100

Other trials in Denmark

Guatemala2 sites

  • Novartis Investigative Site

    Guatemala City, 01010

  • Novartis Investigative Site

    Guatemala City, 01014

Other trials in Guatemala

Ireland2 sites

  • Novartis Investigative Site

    Dublin, D04 T6F

  • Novartis Investigative Site

    Dublin, DUBLIN 9

Other trials in Ireland

Malaysia2 sites

  • Novartis Investigative Site

    Kuala Lumpur, Kuala Lumpur, 50586

  • Novartis Investigative Site

    Kuala Lumpur, 59100

Other trials in Malaysia

Panama2 sites

  • Novartis Investigative Site

    Panama City, 0801

  • Novartis Investigative Site

    Panama City

Other trials in Panama

Estonia1 site

  • Novartis Investigative Site

    Tallinn, 10617

Other trials in Estonia

Jordan1 site

  • Novartis Investigative Site

    Irbid, 22110

Other trials in Jordan

About this study

Official title: 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.

Read the 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.
Being tested
Fingolimod
Keywords
Fingolimod, FTY720, Relapsing forms of MS, Multiple Sclerosis, Efficacy
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FingolimodDrug

    Also called FTY720

    0.5 mg/day

Study groups in NCT01201356
Study groupRoleWhat they receive
Fingolimod 0.5 mg/dayExperimentalOpen-label fingolimod 0.5 mg, taken orally once daily
Receives: Drug: Fingolimod

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (Part I) to Month 6 Follow-up (Part II), up to 8 years

Secondary outcomes (10)

  1. 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.

    Measured: Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)

  2. 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.

    Measured: Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)

  3. 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.

    Measured: Month 0 (Core Baseline) to End of Study (an average of Month 156)

  4. 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.

    Measured: Month 3 to End of Study (Study Completion Visit)

  5. 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.

    Measured: Month 3 to End of Study (Study Completion Visit)

  6. 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.

    Measured: Month 3 to Month 156

  7. 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.

    Measured: Month 3 to Month 156

  8. 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.

    Measured: Month 12 to Month 156

  9. 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.

    Measured: Month 3 to Month 6 Follow-up

  10. 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.

    Measured: Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2010 (estimated)
  2. Study start13 Sep 2010
  3. Primary completion19 Oct 2018
  4. Study completion19 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4,125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01201356
Sponsor's protocol ID
CFTY720D2399
Other IDs
2010-020515-37
Status last verified
Mar 2021
First submitted
10 Sep 2010
Last updated
21 Apr 2021
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

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.

    PubMed 31598139

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fingolimod in people with Relapsing Forms of Multiple Sclerosis, run by Novartis Pharmaceuticals at 458 sites in 38 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 458 sites in Germany, Italy, United States, United Kingdom, Canada and 33 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parts I and II: Number of Participants With Adverse Events, Serious Adverse Event, and Death (time frame: Baseline (Part I) to Month 6 Follow-up (Part II), up to 8 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01201356, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2021.

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