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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,292

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

July 31, 2011

Study Completion Date

July 31, 2011

Conditions
Multiple Sclerosis
Interventions
DRUG

Fingolimod 1.25 mg

"Core: Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.~Extension: Patients self-administered fingolimod 1.25 mg capsules orally once daily until switched to 0.5 mg capsules upon study protocol amendment."

DRUG

Fingolimod 0.5 mg

"Core: Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.~Extension: Patients self-administered fingolimod 0.5 mg capsules orally once daily."

DRUG

Interferon β-1a 30 µg

"Core: Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily.~Extension: Patients self-administered either fingolimod 1.25 mg or 0.5 mg capsules orally once daily until switched to 0.5 mg capsules upon study protocol amendment."

Trial Locations (170)

1010

Evangel.Krankenh./Wien-Waehring Außenstelle, Vienna

1076

Peterfy Sandor u. Hospital, Neurology, U. 8-20m, Budapest

1090

Univ.-Klinik fuer Neurologie AKH, Vienna

UZ Brussel, Laarbeeklaan 101, Brussels

1145

Uzsoki korhaz, Uzsoki U. 29., Budapest

1200

Cliniques Universitaires Saint Luc, Avenue Hippocrate 10, Bruxelles

1428

Ineba, Guarda Vieja 4435, Capital Federal

1820

Nationaal Multiple Sclerose Centrum v.z.w, Melsbroek

2000

Fundacion Rosarina de Neurorehabilitacion, Rosario

Instituto de Neurociencias de Rosario, Rosario

2050

Royal Prince Alfred Hospital, Department of Medicine, Level, Missenden R, Camperdown

2067

Strategic Health Evaluators, Chatswood

2170

Liverpool Hospital, Neurology Department, Health Services Building, 4th Floor, Goulburn and Campbell Street, Liverpool

2217

St George Private Hospital, Suite 7E, Level 5, South Street, Kogarah

2250

Gosford Private Hospital, North Gosford

3050

Royal Melbourne Hospital, Suite 30, Grattan St., Parkbville

3100

Landesklinikum St. Poelten, Probst-Ruehrer-Str. 4, Sankt Pölten

3128

Box Hill Hopsital, Level 3, 16 Arnold Street, Box Hill

3800

Regionaal Ziekenhuis Sint-Trudo - Campus Sint-Jozef, Sint-Truiden

4012

Debreceni Egyetem Orvos es Egszstd. Centr., Debrecen

4031

Universitätsspital Basel, Neurochirugishen Poliklinik, Petersgraben 4, Basel

5000

Fundacion Lenox Cordoba, Córdoba

6020

Universitätsklinik f. Neurologie Innsbruck, Anichstrasse 35, Innsbruck

7623

Pecsi Tudomanyegyetem Neurologiai Klinika, Pécs

8091

Universitätsspital Zuerich, Neurologische Klinik, Frauenklinikstrasse 26, Zuerich

9024

Petz Aladár Megyei Oktató Kórház, Győr

10713

Investigational Site, Berlin

11526

Errikos Dinan General Hospital, 107 Mesogion Ave., Athens

13385

Hopital La Timone Cpcet, Rue Jean Moulin, Marseille

13439

Investigational Site, Berlin

14471

Investigational Site, Potsdam

15213

University of Pittsburgh, Department of Neurology, Pittsburgh

15755

Investigational Site, Teupitz

16132

Az. Osp. Ospedale S. Martino - Università degli Studi, Via Antonio de Toni, 5, Genova

16761

Investigational Site, Hennigsdorf

17475

Investigational Site, Greifswald

20132

Ospedale San Raffaele - IRCCS, Via Olgettina, 48/60, Milano

21013

Ospedale S. Antonio Abate, Via Pastori, 4, Gallarate

21244

Investigational Site, Buchholz

26506

West Virginia University Health Associates, Morgantown

27607

Raleigh Neurology Associates, 1540 Sunday Drive, Raleigh

28035

Puerta de Huerro Univeristy Hospital, San Martin de Porres, 4, Madrid

28040

Hospital Clinico San Carlos, C/ Dr. Martin Lagos, S/n, Madrid

28177

Investigational Site, Bremen

28207

Neuroscience and Spine Center, Charlotte

29010

Complejo Hospitalario Carlos Haya, Avda. Carlos Haya, S/n, Málaga

29615

Absher Neurology, 274-A Commonwealth Drive, Greenville

30623

Investigational Site, Hanover

31059

Hopital De Purpan, Place Du Dr. Baylac, Toulouse Cedex

32209

University of Florida Health Science Center, Jacksonville

32308

AMO Corporation, Tallahassee

32751

Neurology Associates, PA, 301 N. Maitland Avenue, Suite A1, Maitland

32960

The MS Center of Vero Beach, Vero Beach

33060

Neurological Associates, Pompano Beach

33076

Hôpital Pellegrin, Place Amélie Raba Léon, Bordeaux Cedex

33136

University of Miami, Department of Neurology, Miami

33609

Axiom Clinical Research of Florida, 2919 Swann Avenue, Suite 401, Tampa

33612

University of South Florida, Department of Neurology, Tampa

34243

Roskamp Institute, 2040 Whitfield Ave., Sarasota

35058

North Central Neurology Associates, PC, 1809 Kress Street, Cullman

35128

Azienda Ospedaliera di Padova - Università degli Studi, Via Giustiniani, 2, Padova

37064

Advanced Neurosciences Institute, Franklin

37620

Mountain Empire Neurological Associates, PC, 3183 West State Street, Suite 1201, Bristol

40139

Ospedale Bellaria Maggiore, Via Toscana Nazionale, 17/19, Bologna

40225

Investigational Site, Düsseldorf

41009

Hospital Universitario Virgen Macarena, Avenida Dr. Fedriani, 3, Sevilla

44195

Cleveland Clinic, Cleveland

44302

Neurology & Neuroscience Associates, Inc, Akron

44811

Northern Ohio Neuroscience, LLC, Bellevue

45122

Investigational Site, Essen

46009

Hospital Universitario La Fe., Valencia

48013

Hospital de Basurto, Bilbao

49525

Investigational Site, Lengerich

50134

Azienda Ospedaliera Careggi - Università degli Studi, Viale Giovan Battista Morgagni, 85, Firenze

51109

Investigational Site, Cologne

53215

Center for Neurological Disorders - Aurora St. Luke's Med Center, Milwaukee

54035

Hopital Central, 29 Avenue du Marechal de Lattre de Tassigny, Nancy

54292

Investigational Site, Trier

55131

Investigational Site, Mainz

60020

Ospedali Riuniti Umberto I - GM Lancisi - G.Salesi, Via Conca, 71, Torrette Di Ancona

63110

University Physician Group, #1 Barnes-Jewish Hospital Plaza, Suite 16304, St Louis

64711

Investigational Site, Erbach/Odenwald

66100

Osp. Clinicizzato Colle dell'Ara - Università G. D'Annunzio, Via Dei Vestini, 5 Chieti

66160

University of Kansas Medical Center, Kansas City

66214

Mid America Neuroscience Institute, 8550 Marshall Drive, Suite 100, Lenexa

66421

Investigational Site, Hamburg

69120

Investigational Site, Heidelberg

70124

Az. Osp. Ospedale Consorziale e Policlinico, Piazza Giulio Cesare, 11 Bari

72076

Investigational Site, Tübingen

77030

Baylor College of Medicine, Houston

78229

Integra Clinical Research, 4242 Medical Drive, Suite 6100, San Antonio

78303

Centre Hospitalier de Poissy, 10 rue du Champ Gaillard, Poissy

79106

Investigational Site, Freiburg im Breisgau

79410

Private Practice, 3815 23rd Street, Lubbock

80131

Policlinico - Università degli Studi Federico II, Via Pansini, 5, Napoli

80331

Investigational Site, München

81675

Investigational Site, München

85013

Barrow Neurological Institute, Phoenix

86077

Ist. Neurol. Mediterraneo Neuromed, Via Atinense, 18, Pozzilli

89073

Investigational Site, Ulm

89075

Investigational Site, Ulm

92056

The Neurology Center, 3907 Waring Road, Suite 3, Oceanside

95123

Istituto di Scienze Neurologiche Università di Catania, Via Santa Sofia, 78, Catania

96049

Investigational Site, Bamberg

97062

Oregon Neurology, Tualatin

97070

Investigational Site, Würzburg

98122

Swedish Neuroscience Institute, Seattle

99202

Rockwood Clinic, P.S., Spokane

06810

Associated Neurologists, PC, 69 Sand Pit Road, Suite 300, Danbury

06824

Associated Neurologists of Southern CT, PC, 75 Kings Highway Cutoff, Fairfield

06510

Yale University Multiple Sclerosis Center, New Haven

C118ACK

Hospital Italiano de Buenos Aires, Buenos Aires

C1221ADC

Hospital J. M. Ramos Mejia, General Urquiza 609, Buenos Aires

C1428AQK

FLENI, Montaneses 2325, Buenos Aires

A-4020

Landes-Narvenklinik Wagner-Jauregg, Abteilung Fuer Neurologie, Linz

A-5020

Landes-Nervenklinik Christian Doppler Klinik, Ignaz Harrerstr. 79 , Salzburg

41256 900

Hospital Sao Rafael, Salvador

13083-970

Hospital das Clincas - UNICAMP, Campinas

48000-900

Hospital das Clinicas da FMRPUSP, Ribeirão Preto

RS 90020-090

Irmandade da Santa Casa de Misericordia de Porto Alegre, Porto Alegre

RJ 20221-903

Hospital dos Servidores do Estado, Rio de Janeiro

RJ 20270-004

Hospital Universitario Gaffree e Guinle, Rio de Janeiro

V56 2X6

Fraser Health MS Clinic, Burnaby Hospital, 3935 Kincaid Street, Vancouver

V6T 2B5

UBC MS Research, 2211 Westbrook Mall, Vancouver

K2G 6E2

Nepean Medical Centre, 1 Centrepointe Drive, Suite 407, Ottawa

M5B 1W8

St. Michael's Hospital, Chief, Division of Neurology, 30 Bond Street,Suite 3007 - Shuter Wing, Toronto

J1H 5N4

Centre Hospitalier Universitaire de Sherbrooke, 3001 12th Avenue North, Fleurimont

J4V 2H1

Charles Lemoyne Hospital, Greenfield Park

H2L 4M1

CHUM - Hopital Notre-Dame, Montreal

H3A 2B4

Montreal Neurological Institute, 3801 University Street, Montreal

K1H 8L6

The Ottawa General Hospital, 501 Smyth Rd., Ottawa

Unknown

Private Clinic, 48 Sidi Gaber St., Alexandria

35, Dokki St., Apt. 4, Cairo

Al Azhar University, 11 Talaat Harb St, Fourth Floor, Apt 18, Cairo

Private Clinic, 35 Dokki St., Apt. 4, Cairo

Private Clinic, 7 Batal Ahmed Abdelaziz St Abdeen, Cairo

Hospital Sto. António dos, Capuchos

Novartis, Investigational Site

06602

Hoppital Pasteur, Archet II, 30 avenue de la Voie, Romaine

01307

Investigational Site, Dresden

04779

Investigational Site, Wermsdorf

GR 71001

Univ. Hospital of Heraklion, Voutes, Heraklion

G-156 69

General Hospital of Athens G. Gennimatas, 154 Mesogeion Ave., Athens

GR 18547

Metropolitan Hospital, Ethnarchou Makariou 6 & Eleftheriou Venizelou 1, Athens

GR- 26500

General University Hospital of Patra-RIO, Patra - RIO

GR 54636

Ahepa University General Hospital of Thessaloniki, 1 Stilp. Kyriakidi Str., Thessaloniki

H-8200

Veszprem Megyei Csolnoky Ferenc Korhaz, Korhaz U. 1, Veszprem

TO 10043

Azienda Sanitaria Osp. S. Luigi, Gonzaga

CA 09126

Presidio Ospedaliero Roberto Binaghi, Cagliari

FE 44100

Azienda Ospedaliera Universitaria Arcispedale Sant'Anna, Ferrara

PR 43036

Presidio Ospedaliero di Vaio Fidenza, Fidenza

MI 20122

Osp. Magg. Pol. Mangiagalli e Regina Elena - Fond. IRCCS, Milan

MI 20162

Az. Osp. Niguarda Ca' Granda, Milan

BS 25018

Presidio Ospedaliero di Montichiari, Montichiari

PV 27100

IRCCS Neurologico C. Mondino, Pavia

00189

Azienda Ospedaliera Sant'Andrea - Università La Sapienza, Via Di Grottarossa, 1035/1039, Roma

00133

Az. Osp. Universitaria Policlinico Tor Vergata, Via Montpellier, 1, Roma

2720-276

Hospital Fernando Fonseca, Amadora

3000-075

Hospitais da Universidade de Coimbra, Av. Dr. Bissaya Barreto, Coimbra

4200-319

Hospital de São João, Porto

2910-446

Hospital de S. Bernardo, Rua Camilo Castelo Branco, Setubal

411-764

National Cancer Center, 809 Madu 1-dong, Ilsan-gu, Kyunggi

135-710

Samsung Medical Center, Seoul

135-230

Yonsei Univ. Med. Center,Severance Hospital, 134 Shinchon-dong, Suedaemoon-ku, Seoul

700-721

Kyung Pook National University Hospital, Taegu

08907

Ciutat Sanitaria I, Universitaria De Bellvitge, c/o Feixa Llarga, Hospitalet de Llobregat, Barcelona

08035

Unitat de Neuroimmunologia Clinica, Hospital Vall d'Hebron, EUI-planta 2, Pg. Vall d'Hebron 119-29, Barcelona

W8 6RF

Charing Cross Hospital, London

L9 7LJ

The Walton Centre for Neurology and Neurosurgery, Lower Lane, Fazakerly, Liverpool

NR4 7UY

Norfolk & Norwich University Hospital, Norwick

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis

INDUSTRY