Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients

February 21, 2017 updated by: Novartis

A 4-month, Open-label, Multi-center Study to Explore Tolerability and Safety and Health Outcomes of FTY720 in Patients With Relapsing Forms of Multiple Sclerosis

This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720.

Study Overview

Status

Completed

Conditions

Relapsing Multiple Sclerosis

Intervention / Treatment

Drug: FTY720

Study Type

Interventional

Enrollment (Actual)

2417

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- - Box Hill, Australia, 3128
    - Novartis Investigative Site
  - Heidelberg, Australia, 3084
    - Novartis Investigative Site
  - Kogarah, Australia, 2217
    - Novartis Investigative Site
  - Liverpool, Australia, 2170
    - Novartis Investigative Site
  - Woodville South, Australia, 5011
    - Novartis Investigative Site
Austria
- - Linz, Austria, A-4020
    - Novartis Investigational Site
  - Vienna, Austria, 1010
    - Novartis Investigational Site
  - Vienna, Austria, 1090
    - Novartis Investigational Site
Belgium
- - Brugge, Belgium, 8000
    - Novartis Investigational Site
  - Bruxelles, Belgium, 1070
    - Novartis Investigational Site
  - Bruxelles, Belgium, 1200
    - Novartis Investigational Site
  - Charleroi, Belgium, 6000
    - Novartis Investigational Site
  - Leuven, Belgium, 3000
    - Novartis Investigational Site
  - Melsbroek, Belgium, 1820
    - Novartis Investigational Site
  - Overpelt, Belgium, 3900
    - Novartis Investigational Site
  - Sijsele, Belgium, 8340
    - Novartis Investigational Site
  - Tinlot, Belgium, 4557
    - Novartis Investigational Site
  - Wilrijk, Belgium, 2610
    - Novartis Investigational Site
Canada
- - Montreal, Canada, H2L 4M1
    - Novartis Investigational Site
  - Quebec, Canada, G1J 1Z4
    - Novartis Investigational Site
  - Victoria, Canada, V8R 1J8
    - Novartis Investigational Site
Czech Republic
- - Praha 2, Czech Republic, 128 02
    - Novartis Investigational Site
  - Teplice, Czech Republic, 415 29
    - Novartis Investigational Site
Denmark
- - Copenhagen, Denmark, 2100
    - Novartis Investigational Site
  - Århus, Denmark, DK-8000
    - Novartis Investigational Site
Finland
- - Helsinki, Finland, 00100
    - Novartis Investigational Site
  - Turku, Finland, 20520
    - Novartis Investigational Site
Germany
- - Aachen, Germany, 52062
    - Novartis Investigative Site
  - Aachen, Germany, 52062
    - Novartis Investigational Site
  - Aalen, Germany, 73430
    - Novartis Investigational Site
  - Abensberg, Germany, 93326
    - Novartis Investigational Site
  - Achim, Germany, 28832
    - Novartis Investigational Site
  - Alzenau, Germany, 63755
    - Novartis Investigational Site
  - Aschaffenburg, Germany, 63739
    - Novartis Investigational Site
  - Attenberg, Germany, 04600
    - Novartis Investigational Site
  - Augsburg, Germany, 86156
    - Novartis Investigational Site
  - Bad Honnef, Germany, 53604
    - Novartis Investigational Site
  - Bad Krozingen, Germany, 79189
    - Novartis Investigational Site
  - Bad Mergentheim, Germany, 97980
    - Novartis Investigative Site
  - Bad Neustadt / Saale, Germany, 97616
    - Novartis Investigational Site
  - Bamberg, Germany, 96047
    - Novartis Investigational Site
  - Bamberg, Germany, 96049
    - Novartis Investigational Site
  - Bayreuth, Germany, 95445
    - Novartis Investigative Site
  - Berlin, Germany, 10117
    - Novartis Investigative Site
  - Berlin, Germany, 10713
    - Novartis Investigative Site
  - Berlin, Germany, 12163
    - Novartis Investigative Site
  - Berlin, Germany, 13347
    - Novartis Investigative Site
  - Berlin, Germany, 10178
    - Novartis Investigative Site
  - Berlin, Germany, 12103
    - Novartis Investigative Site
  - Berlin, Germany, 12351
    - Novartis Investigative Site
  - Berlin, Germany, 13507
    - Novartis Investigative Site
  - Berlin, Germany, 10625
    - Novartis Investigative Site
  - Berlin, Germany, 10961
    - Novartis Investigative Site
  - Berlin, Germany, 14163
    - Novartis Investigative Site
  - Berlin, Germany, 10785
    - Novartis Investigative Site
  - Berlin, Germany, 13439
    - Novartis Investigative Site
  - Berlin, Germany, 13088
    - Novarris Investigative Site
  - Bielefeld, Germany, 33617
    - Novartis Investigative Site
  - Bielefeld, Germany, 33647
    - Novartis Investigative Site
  - Bielefeld, Germany, 33602
    - Novartis Investigative Site
  - Boblingen, Germany, 71034
    - Novartis Investigative Site
  - Bochum, Germany, 44789
    - Novartis Investigative Site
  - Bochum, Germany, 44787
    - Novartis Investigational Site
  - Bochum, Germany, 44791
    - Novartis Investigational Site
  - Bochum, Germany, 44892
    - Novaratis Investigative Site
  - Bogen, Germany, 94327
    - Novartis Investigational Site
  - Bonn, Germany, 53105
    - Novartis Investigative Site
  - Bonn, Germany, 53117
    - Novartis Investigative Site
  - Braunschweig, Germany, 38126
    - Novartis Investigational Site
  - Buchholz, Germany, 21244
    - Novartis Investigational Site
  - Chemnitz, Germany, 09117
    - Novartis Investigational Site
  - Dillingen, Germany, 89407
    - Novartis Investigational Site
  - Dresden, Germany, 01307
    - Novartis Investigative Site
  - Düsseldorf, Germany, 40211
    - Novartis Investigative Site
  - Eisenach, Germany, 99817
    - Novartis Investigational Site
  - Emden, Germany, 26721
    - Novartis Investigative Site
  - Emmendingen, Germany, 79312
    - Novartis Investigational Site
  - Erbach, Germany, 64711
    - Novartis Investigative Site
  - Erfurt, Germany, 99089
    - Novartis Investigational Site
  - Erlangen, Germany, 91054
    - Novartis Investigational Site
  - Essen, Germany, 45138
    - Novartis Investigative Site
  - Essen, Germany, 103949
    - Novartis Investigative Site
  - Essen, Germany, 45131
    - Novartis Investigational Site
  - Frankfurt, Germany, 60488
    - Novartis Investigational Site
  - Frankfurt, Germany, 60528
    - Novartis Investigational Site
  - Freiburg, Germany, 79106
    - Novartis Investigative Site
  - Greifswald, Germany, 17487
    - Novartis Investigational Site
  - Grevenbroich, Germany, 41515
    - Novartis Investigational Site
  - Hamburg, Germany, 20354
    - Novartis Investigative Site
  - Hamburg, Germany, 20099
    - Novartis Investigative Site
  - Hamburg, Germany, 22083
    - Novartis Investigative Site
  - Hamburg, Germany, 20249
    - Novartis Investigative Site
  - Hamburg, Germany, 22179
    - Novartis Investigative Site
  - Hamburg, Germany, 22087
    - Novartis Investigational Site
  - Hamburg, Germany, 22291
    - Novartis Investigational Site
  - Hamburg, Germany, 22297
    - Novartis Investigative Site
  - Hamburg, Germany, 22523
    - Novartis Investigative Site
  - Hannover, Germany, 30625
    - Novartis Investigative Site
  - Hannover, Germany, 30161
    - Novartis Investigative Site
  - Hannover, Germany, 30559
    - Novartis Investigative Site
  - Heidelburg, Germany, 69120
    - Novartis Investigative Site
  - Herborn, Germany, 35745
    - Novartis Investigational Site
  - Herdecke, Germany, 58313
    - Novartis Investigational Site
  - Herne, Germany, 44651
    - Novartis Investigational Site
  - Homburg, Germany, 66421
    - Novartis Investigational Site
  - Itzehoe, Germany, 25524
    - Novartis Investigational Site
  - Jena, Germany, 07740
    - Novartis Investigational Site
  - Jena, Germany, 07743
    - Novartis Investigational Site
  - Kaltenkirchen, Germany, 24568
    - Novartis Investigational Site
  - Kandel, Germany, 76870
    - Novartis Investigative Site
  - Karlsruhe, Germany, 76133
    - Novartis Investigational Site
  - Karlstadt, Germany, 97753
    - Novartis Investigational Site
  - Kassel, Germany, 34121
    - Novartis Investigational Site
  - Koeln, Germany, 51109
    - Novartis Investigative Site
  - Koln, Germany, 50935
    - Novartis Investigative Site
  - Koln, Germany, 50924
    - Novartis Investigative Site
  - Krefeld, Germany, 47805
    - Neuroscience Research of the Berkshires
  - Landshut, Germany, 84028
    - Novartis Investigational Site
  - Lappersdorf, Germany, 93138
    - Novartis Investigational Site
  - Leipzig, Germany, 04275
    - Novartis Investigational Site
  - Lengerich, Germany, 49525
    - Novartis Investigative Site
  - Lohr am Main, Germany, 79816
    - Novartis Investigational Site
  - Ludwigshafen, Germany, 67063
    - Novartis Investigative Site
  - Ludwigshafen, Germany, 67059
    - Novartis Investigational Site
  - Magdeburg, Germany, 39120
    - Novartis Investigative Site
  - Mainz, Germany, 55101
    - Novartis Investigative Site
  - Mannheim, Germany, 68159
    - Novartis Investigational Site
  - Marburg, Germany, 35033
    - Novartis Investigational Site
  - Marburg, Germany, 35039
    - Novartis Investigational Site
  - Mittweida, Germany, 09648
    - Novartis Investigational Site
  - Muenchen, Germany, 80331
    - Novartis Investigational Site
  - Muenchen, Germany, 81377
    - Novartis Investigational Site
  - Muenster, Germany, 48149
    - Novartis Investigational Site
  - Munchen, Germany, 81829
    - Novartis Investigational Site
  - Mönchengladbach, Germany, 41063
    - Novartis Investigational Site
  - München, Germany, 81241
    - Novartis Investigational Site
  - München, Germany, 81675
    - Novartis Investigational Site
  - München, Germany, 81825
    - Novartis Investigative Site
  - Nagold, Germany, 72202
    - Novartis Investigational Site
  - Neu-Ulm, Germany, 89231
    - Novartis Investigational Site
  - Neuburg, Germany, 86633
    - Novartis Investigational Site
  - Neuruppin, Germany, 16816
    - Novartis Investigational Site
  - Nurnberg, Germany, 90461
    - Novartis Investigational Site
  - Oldenburg, Germany, 26122
    - Novartis Investigative Site
  - Osnabrück, Germany, 49076
    - Novartis Investigational Site
  - Ostfildern, Germany, 73760
    - Novartis Investigational Site
  - Pforzheim, Germany, 75172
    - Novartis Investigational Site
  - Potsdam, Germany, 14467
    - Novartis Investigational Site
  - Potsdam, Germany, 14471
    - Novartis Investigational Site
  - Prien, Germany, 83209
    - Novartis Investigational Site
  - Regensburg, Germany, 93053
    - Novartis Investigational Site
  - Rostock, Germany, 18147
    - Novartis Investigational Site
  - Rudersdorf, Germany, 15562
    - Novartis Investigative Site
  - Rösrath, Germany, 51503
    - Novartis Investigational Site
  - Schwarzenbruck, Germany, 90592
    - Novartis Investigational Site
  - Schwendi, Germany, 88477
    - Novartis Investigative Site
  - Siegen, Germany, 57072
    - Novartis Investigative Site
  - Sigmaringen, Germany, 72488
    - Novartis Investigational Site
  - Sinsheim, Germany, 74889
    - Novartis Investigational Site
  - Stade, Germany, 21682
    - Novartis Investigative Site
  - Stuttgart, Germany, 70178
    - Novartis Investigative Site
  - Stuttgart, Germany, 70182
    - Novartis Investigative Site
  - Stuttgart, Germany, 70176
    - Novartis Investigational Site
  - Stuttgart, Germany, 70191
    - Novartis Investigational Site
  - Teupitz, Germany, 15755
    - Novartis Investigational Site
  - Tübingen, Germany, 72076
    - Novartis Investigational Site
  - Ulm, Germany, 89073
    - Novartis Investigative Site
  - Unterhaching, Germany, 82008
    - Novartis Investigational Site
  - Wendlingen, Germany, 73240
    - Novartis Investigational Site
  - Wermsdorf, Germany, 04779
    - Novartis Investigational Site
  - Westerstede, Germany, 26655
    - Novartis Investigational Site
  - Wiesbaden, Germany, 65191
    - Novartis Investigative Site
  - Wiesbaden, Germany, 65183
    - Novartis Investigational Site
  - Wuppertal, Germany, 42283
    - Novartis Investigational Site
  - Würzburg, Germany, 97080
    - Novartis Investigational Site
Greece
- - Alexandroupolis, Greece, 68100
    - Novartis Investigational Site
  - Athens, Greece, 10675
    - Novartis Investigational Site
  - Athens, Greece, 15123
    - Novartis Investigational Site
  - Thessaloniki, Greece, 57001
    - Novartis Investigational Site
  - Thessaloniki, Greece, GR 570 10
    - Novartis Investigational Site
Hungary
- - Budapest, Hungary, 1083
    - Novartis Investigational Site
  - Budapest, Hungary, 1115
    - Novartis Investigational Site
  - Budapest, Hungary, 1204
    - Novartis Investigational Site
  - Pecs, Hungary, 7623
    - Novartis Investigational Site
  - Szeged, Hungary, H-6725
    - Novartis Investigational Site
Ireland
- - Cork, Ireland
    - Novartis Investigational Site
  - Dublin 4, Ireland
    - Novartis Investigational Site
  - Dublin 9, Ireland
    - Novartis Investigational Site
Italy
- - Acquaviva delle Fonti, Italy, 70021
    - Novartis Investigative Site
  - Asti, Italy, 14100
    - Novartis Investigative Site
  - Bergamo, Italy, 24128
    - Novartis Investigative Site
  - Bologna, Italy, 40139
    - Novartis Investigative Site
  - Cagliari, Italy, 09126
    - Novartis Investigative Site
  - Catania, Italy, 95122
    - Novartis Investigative Site
  - Foggia, Italy, 71100
    - Novartis Investigational Site
  - Foggia, Italy, 71100
    - Novartis Investigative Site
  - Milano, Italy, 20132
    - Novartis Investigative Site
  - Napoli, Italy, 80131
    - Novartis Investigative Site
  - Napoli, Italy, 80132
    - Novartis Investigational Site
  - Napoli, Italy, 80138
    - Novartis Investigational Site
  - Palermo, Italy, 90146
    - Novartis Investigative Site
  - Pozzilli, Italy, 86077
    - Novartis Investigative Site
  - Ravenna, Italy, 48100
    - Novartis Investigative Site
  - Roma, Italy, 00135
    - Novartis Investigational Site
  - Roma, Italy, 00161
    - Novartis Investigational Site
  - Roma, Italy, 00168
    - Novartis Investigational Site
  - Roma, Italy, 00185
    - Novartis Investigational Site
  - Siena, Italy, 53100
    - Novartis Investigative Site
  - Udine, Italy, 33100
    - Novartis Investigative Site
  - Verona, Italy, 37134
    - Novartis Investigative Site
  - Vicenza, Italy, 36100
    - Novartis Investigative Site
  - Viterbo, Italy, 01100
    - Novartis Investigative Site
Netherlands
- - Amsterdam, Netherlands, 1061 AE
    - Novartis Investigational Site
  - Amsterdam, Netherlands, 1081 HV
    - Novartis Investigational Site
  - Blaricum, Netherlands, 1261 AN
    - Novartis Investigational Site
  - Breda, Netherlands, 4818 CK
    - Novartis Investigational Site
  - Enschede, Netherlands, 7513 ER
    - Novartis Investigational Site
  - Gouda, Netherlands, 2800 BB
    - Novartis Investigational Site
  - Tilburg, Netherlands, 5022 GC
    - Novartis Investigational Site
Norway
- - Lillehammer, Norway, 2609
    - Novartis Investigational Site
  - Molde, Norway, 6407
    - Novartis Investigational Site
  - Stavanger, Norway, 4868
    - Novartis Investigational Site
Poland
- - Bydgoszcz, Poland, 85-681
    - Novartis Investigational Site
  - Katowice, Poland, 40-594
    - Novartis Investigational Site
  - Lodz, Poland, 90-153
    - Novartis Investigational Site
Portugal
- - Amadora, Portugal, 2720-276
    - Novartis Investigational Site
  - Coimbra, Portugal, 3041-853
    - Novartis Investigational Site
  - Lisboa, Portugal, 1649-035
    - Novartis Investigational Site
  - Porto, Portugal, 4099-001
    - Novartis Investigational Site
  - Porto, Portugal, 4200-319
    - Novartis Investigational Site
Russian Federation
- - Ekaterinburg, Russian Federation, 620102
    - Novartis Investigational Site
  - Kazan, Russian Federation, 420021
    - Novartis Investigational Site
  - Kazan, Russian Federation, 420097
    - Novartis Investigational Site
  - Moscow, Russian Federation, 121356
    - Novartis Investigational Site
  - Moscow, Russian Federation, 125367
    - Novartis Investigational Site
  - Moscow, Russian Federation, 127018
    - Novartis Investigational Site
  - Nizhny Novgorod, Russian Federation, 603018
    - Novartis Investigational Site
  - Nizhny Novgorod, Russian Federation, 603155
    - Novartis Investigational Site
  - S.-Petersburg, Russian Federation, 194044
    - Novartis Investigational Site
  - Samara, Russian Federation, 443095
    - Novartis Investigational Site
  - Smolensk, Russian Federation, 214019
    - Novartis Investigational Site
  - St. Petersburg, Russian Federation, 197376
    - Novartis Investigational Site
Slovakia
- - Banska Bystrica, Slovakia, 975 17
    - Novartis Investigational Site
  - Bratislava, Slovakia, 82606
    - Novartis Investigational Site
  - Trnava, Slovakia, 917 75
    - Novartis Investigational Site
Spain
- - Barcelona, Spain, 08025
    - Novartis Investigational Site
  - Barcelona, Spain, 08036
    - Novartis Investigational Site
  - El Palmar, Spain, 30120
    - Novartis Investigational Site
  - Madrid, Spain, 28034
    - Novartis Investigational Site
  - Madrid, Spain
    - Novartis Investigational Site
  - San Sebastian, Spain, 20014
    - Novartis Investigational Site
  - Santa Cruz de Tenerife, Spain, 38009
    - Novartis Investigational Site
  - Santiago de Compostela, Spain, 15706
    - Novartis Investigational Site
  - Valencia, Spain, 46010
    - Novartis Investigational Site
Sweden
- - Göteborg, Sweden, 413 45
    - Novartis Investigational Site
  - Linköping, Sweden, 581 85
    - Novartis Investigational Site
  - Umea, Sweden, 901 85
    - Novartis Investigational Site
Switzerland
- - Aarau, Switzerland, 5001
    - Novartis Investigational Site
  - Carouge, Switzerland, 1227
    - Novartis Investigational Site
  - Geneve, Switzerland, 1211
    - Novartis Investigational Site
  - Lausanne, Switzerland, 1011
    - Novartis Investigational Site
  - Lugano, Switzerland, 6900
    - Novartis Investigational Site
  - St. Gallen, Switzerland, 9007
    - Novartis Investigational Site
  - Zuerich, Switzerland, 8091
    - Novartis Investigational Site
Turkey
- - Antalya, Turkey, 07070
    - Novartis Investigational Site
  - Gaziantep, Turkey, 27070
    - Novartis Investigational Site
  - Istanbul, Turkey, 34096
    - Novartis Investigational Site
  - Istanbul, Turkey, 34098
    - Novartis Investigational Site
  - Samsun, Turkey
    - Novartis Investigational Site
  - Trabzon, Turkey, 61080
    - Novartis Investigational Site
United Kingdom
- - Birmingham, United Kingdom, B15 2TH
    - Novartis Investigational Site
  - Brighton, United Kingdom, BN2 2BE
    - Novartis Investigational Site
  - Dundee, United Kingdom
    - Novartis Investigational Site
  - Edinburgh, United Kingdom, EH4 2XU
    - Novartis Investigational Site
  - Essex, United Kingdom, RM7 0BE
    - Novartis Investigational Site
  - Great Yarmouth, United Kingdom, NR31 6LA
    - Novartis Investigational Site
  - Headington, United Kingdom, OX3 9DU
    - Novartis Investigational Site
  - Liverpool, United Kingdom, L9 7LJ
    - Novartis Investigational Site
  - London, United Kingdom, SW17 0QT
    - Novartis Investigational Site
  - London, United Kingdom, W8 6RF
    - Novartis Investigational Site
  - Middlesborough, United Kingdom, TS4 3BW
    - Novartis Investigational Site
  - Newcastle Upon Tyne, United Kingdom, NE1 4LP
    - Novartis Investigational Site
  - Northampton, United Kingdom, NN1 5BD
    - Novartis Investigational Site
  - Norwick, United Kingdom, NR4 7UY
    - Novartis Investigational Site
  - Poole, United Kingdom, BH15 2JB
    - Novartis Investigational Site
  - Salford, United Kingdom, M6 8HD
    - Novartis Investigational Site
  - Sheffield, United Kingdom, S10 2JF
    - Novartis Investigational Site
  - Stoke on Trent, United Kingdom, ST4 6QG
    - Novartis Investigational Site
  - Swindon, United Kingdom, SN3 6BB
    - Novartis Investigational Site
  - Truro, United Kingdom, TR1 3LJ
    - Novartis Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

18-65 years of age, must have relapsing MS

Exclusion Criteria:

Patients with a type of MS that is not relapsing
Patients with history of chronic immune disease
Patients with a history of certain cancers
Diabetic patients with certain eye disorders
Patients who are on certain immunosuppressive medications or heart medications
Patients with certain heart conditions
Patients with certain lung conditions

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FTY720	Drug: FTY720

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS Time Frame: 4 months	4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of macular edema Time Frame: 4 months	4 months
Incidence of bradyarrhythmic electrocardiograms (ECGs) Time Frame: 4 months	4 months
Patient reported outcomes indices in multiple sclerosis (PRIMUS), short form health survey-12, and treatment satisfaction questionnaire for medication (TSQM-9) Time Frame: 4 months	4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Gold R, Comi G, Palace J, Siever A, Gottschalk R, Bijarnia M, von Rosenstiel P, Tomic D, Kappos L; FIRST Study Investigators. Assessment of cardiac safety during fingolimod treatment initiation in a real-world relapsing multiple sclerosis population: a phase 3b, open-label study. J Neurol. 2014 Feb;261(2):267-76. doi: 10.1007/s00415-013-7115-8. Epub 2013 Nov 13.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

May 19, 2010

First Submitted That Met QC Criteria

May 19, 2010

First Posted (Estimate)

May 21, 2010

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CFTY720D2316
2010-019029-32 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Bristol-Myers Squibb

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A Study to Describe the Persistence With Ozanimod Treatment in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants (AppreZiate)

Relapsing-remitting Multiple Sclerosis (RRMS)

Spain
Hoffmann-La Roche
PPD Development, LP

Active, not recruiting

A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS) (Operetta 2)

Relapsing-Remitting Multiple Sclerosis

United States, Spain, Canada, Portugal, India, United Kingdom, Belgium, France, Brazil, Austria, Germany, Hungary, Estonia, Poland, Mexico, Australia, Italy, Ukraine, Serbia, Latvia, Morocco, Argentina, Switzerland, Greece, Romania
Biogen

Withdrawn

A Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-a (PRTOECT)

Relapsing-remitting Multiple Sclerosis

Clinical Trials on FTY720

University Hospital, Basel, Switzerland
Novartis

Completed

Study to Assess Safety and Efficacy of Fingolimod in Children With Rett Syndrome (FINGORETT)

Rett's Syndrome

Switzerland
Novartis Pharmaceuticals

Recruiting

Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis (SPRING)

Multiple Sclerosis

Taiwan
Novartis Pharmaceuticals

Completed

Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients

Relapsing Multiple Sclerosis (RMS)

China
Novartis

Completed

Pharmacokinetics (PK) and Metabolism of FTY720 in Patients With Severe Renal Impairment and Healthy Matched Subjects.

Renal Insufficiency

Russian Federation
Novartis Pharmaceuticals

Terminated

This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS. (INFORMS)

Primary Progressive Multiple Sclerosis

United States, Belgium, Poland, Germany, Hungary, Turkey, Spain, Australia, Canada, Czechia, Switzerland, United Kingdom, Netherlands, France, Italy, Denmark, Finland, Sweden
Novartis Pharmaceuticals

Completed

Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant

Kidney Transplantation
Tianjin Medical University General Hospital

Completed

Efficacy and Safety of FTY720 for Acute Stroke

Stroke | Stroke, Acute | Cerebral Stroke | Ischemic Cerebrovascular Accident | Vascular Accident

China
Novartis Pharmaceuticals

Completed

Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks

Multiple Sclerosis

Italy, Belgium, Germany
Novartis

Completed

Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis

Multiple Sclerosis

Switzerland, Germany, Spain, Portugal, Canada, Denmark, Finland, France, Italy, Poland, United Kingdom
Novartis

Completed

A Study of the Effect of FTY720 on Pulmonary Function in Patients With Moderate Asthma

Asthma

United Kingdom

Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients

A 4-month, Open-label, Multi-center Study to Explore Tolerability and Safety and Health Outcomes of FTY720 in Patients With Relapsing Forms of Multiple Sclerosis

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Relapsing Multiple Sclerosis

Clinical Trials on FTY720

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