Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis

PHASE3CompletedINTERVENTIONAL
Enrollment

1,272

Participants

Timeline

Start Date

January 31, 2006

Primary Completion Date

July 31, 2009

Study Completion Date

July 31, 2009

Conditions
Relapsing-remitting Multiple Sclerosis
Interventions
DRUG

Fingolimod 1.25 mg

Patients self-administered fingolimod 1.25 mg capsules orally once daily.

DRUG

Fingolimod 0.5 mg

Patients self-administered fingolimod 0.5 mg capsules orally once daily.

DRUG

Placebo

Patients self-administered a fingolimod placebo capsule orally once daily.

Trial Locations (115)

1011

Centre Hospitalier, Universitaire Vaudois Policlinique de Neurologie, Rue Du Bugnon

1070

Erasme Hospital, Route de Lennik 808

1081

Academisch Ziekenhuis VU, De Boelelaan 1118

1820

National Multiple Sclerose Centrum v.z.w, Vanheylenstraat 16, Melsbroek

2067

Strategic Health Evaluators, Chatswood

2196

Private Neurologist (Morningside Medi-Clinic), Suite C, Block C, Rochester Place, Sandton

3000

University Hospital Gasthuisberg, Department Neurology, Herestraat 49

3046

Faculty Hospital, Department of Neurology, Alej Svobody 80

3084

Austin Health, Department of Neurology, Heidelberg

3800

Regionaal Ziekenhuis, St.Trudo, Diestersteenweg 100,

3900

MS Klinik, Boemerangstraat 2, Overpelt

4031

Kantonsspital Basel, Policlinic, Neurology-Neurosurgical, Petersgraben 4

4319

Umhlanga Hospital, Umhlanga

5011

The Queen Elizabeth Hospital, Woodville South

5022

Sint Elisabeth Ziekenhuis, Hilvarenbeekse Weg 60

6000

CHU Charleroi, Hôpital Civil, Boulevard Paul Janson 92

6131

Maaslandziekenhuis Sittard, Walramstraat 23, BK Sittard

6533

Multiple Clerosis Center Nijmegen, Heiweg 97

7925

Division of Neurology, Groote Schuur Hospital, E 8-74, Groote Schuur Hospital, Observatory Cape Town

8000

Algemeen Ziekenhuis St. Jan, Department of Neurology, Ruddershove

8091

UniversitätsSpital Zürich, Neurologische Klinik, Frauenklinikstr. 26, Zurich

8340

AZ Alma, Department of Neurology & Rehab-Umit, Gentsesteenweg 132

10034

Neurologicka klinika, Fakultni nemocnice, Kralovske Vinohrady, Srobarova 50

10117

Investigational Site, Berlin

11521

Athens Naval Hospital, Neurology Department, Athens

11527

Neurology Department Athens General Hospital, G. Gennimatas, Mesogeion 154 Ave., Athens

12808

Vseobecna fakultni nemocnice, MS Centrum, Neurologicka Klinika, Karlovo Namesti 32

13100

Sieff Medical Center, Safed

13347

Investigational Site, Berlin

13385

CHU La Timone, Service Neurologie, Boulevard Jean Moulin, Marsielle Cedex 5

14186

Karolinska University Hospital Huddinge, Department of Neurology R54, Stockholm

15006

Faculty Hospital Motol, MS Center, Department of Neurology, V Uvalu 84

15127

1st IKA Papadimitriou Neurology Dept, Terma Zaimi, Melissia-Athens

20099

Investigational Site, Hamburg

20100

Finnish Special Neurology Center Ltd., Brahenkatu 11 D,

20246

Investigational Site, Hamburg

20520

Turku University Hospital, Neurology Department 799, Kiinanmyllynkatu 11- 14, Turku

27070

Gaziantep University School of Medicine, Neurology Department

33079

Mersin Universitesi Tip Fakultesi Hastanesi, Noroloji ABD, Mersin

33200

Suomen Terveystalo/ Päänsärkykeskus, Tampere, Hämeenkatu 18, 6th Fl., Tampere

34093

Istanbul University, Istanbul Faculty of Medicine, Departement of Neurology

34098

Istanbul University, Cerrahpasa School of Medicine, Department of Neurology

34147

Bakirkoy Ruh ve Sinir Hastaliklari Hastanesi, Istanbul

34362

Carmel Medical Center, Haifa

34722

T.C. Saglik Bakanligi Goztepe Egitim ve Arastirma Hastanesi, Noroloji Klinigi, Göztepe Istanbul

35100

EGE University, Medical Faculty Hospital Neurolgy Department

35340

Dokuz University Medical Faculty, Neurology Department, Inciralti, Izmir

35385

Investigational Site, Giessen

38723

Investigational Site, Seesen/Harz

39120

Investigational Site, Magdeburg

40225

Investigational Site, Düsseldorf

41345

MS Centrum, Forskningsenhet, SU/Östra CKÖ Plan 0

41529

MS Centrum, Neurology Department of Hospital Teplice, Duchcovska 53

48149

Investigational Site, Münster

51601

Centrum neurologicke pece, Jiraskova 1389, Rychnov Nad Kneznou

52621

Sheba - Medical Center, Tel Hashomer, Ramat-Gan,

53203

Hospital of Pardubice, Department of Neurology, Kyjevska 44

54636

"University General Hospital of Thessaloniki AHEPA, B' University Department of Neurology", Thessaloniki

63600

Military Hospital of Brno, Department of Neurology, Zabrdovicka 3

65691

Faculty Hospital St. Anne, First Department of Neurology, Pekarska 53

70191

Investigational Site, Stuttgart

70852

Facultní Nemocnice Spoliklinikou Ostrava, Neurology Department, Ostrava

72076

Investigational Site, Tübingen

77520

Faculty Hospital, Department of Neurology, I.P. Paulova 6

78306

Barzilai Medical Center, Ashkelon

80331

Investigational Site, München

81377

Investigational Site, München

93053

Investigational Site, Regensburg

97080

Investigational Site, Würzburg

121356

Central Clinical Hospital of Medical Center of Administration of President of Russian Federation, Moscow

129110

Moscow Regional Research Clinical Institue, Moscow

194044

Military Medical Academy, Neurology Department, Saint Petersburg

420111

Interregional Clinical Diagnistic Center, Neurology Department, Kazan'

NSW 2250

North Gosford Private Hospital, Burrabil Avenue, Suite 17, Gosford

3065 VIC

St Vincent's Hospital Melbourne, Department of Clinical Neurosciences, Fitzroy

V6T 2B5

University of British Columbia, Me498 2211 Wesbrook Mall, Vancouver

Unknown

DMSRU - Capital Health, Halifax

Medical University of Lodz, Lodz

"GUZ Central Medical Sanitary Department #122 of Federal Medical-Biological agency, Neurology department", Saint Petersburg

Hacettepe Universiti Hospitals, Department of Neurology

Uludag University Faculty of Medche, Tip Fakultesi, Noroloji ABD

Tepecik Training and Research, Hospital Neurology Service, 35120 Gaziler Cad. Izmir

K7L 2V7

Kingston General Hospital, MS Clinic, Connell 7, 76 Stuart Street, Kingston

K2G 6E2

Nepean Medical Center, Ottawa

M5B 1W8

St. Michael's Hospital, Toronto

L5B 1B8

Clinical Trials Office,, Trillium Health Center, 00 Queesway West, Mississauga

H1T 2M4

Hopital Maisonneuve-Rosemont, Recherche Clinique de Neurologie, Montreal

S4T 1A5

University of Saskatchewan, Regina

0100

Helsinki Headache Center Postitalon Lääkäriasema, Mannnerheiminaukio 1 B 2 Floor

05850

Hyvinkään sairaala, Neurologian Poliklinikka, Sairaalankatu 1, Hyvinkää

04103

Investigational Site, Leipzig

LY-50009

Kaunas University Hospital Department of Neurology, Eiveniu 2, Kaunas

3430 EM

St. Antonius Ziekenhuis, Postbus 2500

3015 GD

Erasmus MC, Dr. Molewaterplein 40

15-276

Samodzielny Publiczny Szpital Kliniczny, Klinika Neurologii, Ul. Marii Skłodowskiej-Curie 24 A

15-420

Niezalezny Zespol Opieki Zdrowotnej Kendron, Ul. Swietego Mikolaja 1/8

80-803

Oddzial Neurologiczny i Leczenia Udarow, Mozgu, Nowe Ogrody 1/6

40-752

Katedra i Klinika Neurologii Slaskiej Akademii Medycznej, Ul. Medykow 14

60-355

Univ. Med. Sci. Poznan, Katedra i Klinika Neurologii,, Department of Neurology, Ul. Przybyszewskiego 49

02-507

CSK MSWiA Hospital, Department of Neurology, Wołoska 137

02-957

Jadwiga Kruszewska-Ozimska, Instytut Psychiatrii i Neurologii, II Klinika Neurologii, Ul. Sobieskiego 1/9

00-909

Centralny Szpital Kliniczny, Klinika Neurologii, MSWiAw Warszawie, Woloska 137

01-097

Katedra i Klinika Neurologii Centralny Szpital Kliniczny AM w Warszawie, Ul. Banacha 1A

833 05

II. Neurologická klinika Fakultná nemocnica s poliklinikou Bratislava pracovisko Kramáre, Limbová 5

03659

Neurologická klinika, Martinská fakultná nemocnica, Kollárova 2, Martin

813 69

I. Neurologická klinika, Fakultná nemocnica s poliklinikou Bratislava pracovisko Staré mesto, Mickiewiczova 13, Bratislava

012 07

Neurologické oddelenie, Nemocnica s poliklinikou Žilina, ul.V. Spanyola 43, Žilina

171 76

Karolinska University Hospital, Department of Medicine, Neuroimmunology Unit, CMM L8:04, Stockholm

06500

Gazi University, Medical Faculty Neurology Department

SES 8AF

King's College Hospital, Trials office Academie Neuroscience Center, P041 Institute of Psychiatry, Denmark Hill

NG7 24H

Queens Medical Centre, Division of Clinical Neurology Medical School

S102JF

Royal Hallamshire Hospital, Glossop Road

Tooting London SW17 0QT

St. George's Hospital, Neurology Dept. Atkinson Morley Wing, Backshaw Road, London

BS16 1LE

Frenchay Hospital, Department of Neurology, Beckspool Road, Bristol

NE1 4LP

Royal Victoria Infirmary, Queen Victoria Road, Newcastle-upon-Tyne

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis

INDUSTRY