Safety and Efficacy of Natalizumab in the Treatment of Multiple Sclerosis

PHASE3CompletedINTERVENTIONAL
Enrollment

900

Participants

Timeline

Start Date

November 30, 2001

Primary Completion Date

November 30, 2004

Study Completion Date

January 31, 2005

Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
DRUG

Natalizumab

Natalizumab 300 mg IV infusion, every 4 weeks, for up to 116 weeks.

DRUG

Placebo

Placebo, IV infusion, every 4 weeks, for up to 116 weeks.

Trial Locations (53)

1820

National MS Centrum, Melsbroek

3590

LUC- University Centre, Diepenbeek

8000

Algemeen Ziekenhuis St. Jan, Bruges

13385

Hopital de la Timone, Service de Neurologie, Marseille

18103

Lehigh Valley Hospital, Neurosciences Research, Allentown

33136

University of Miami School of Medicine, Department of Neurology, Miami

35033

CHRU - Hopital de Pontchaillou, Service de Neurologie, Rennes

44791

St. Josef-Hospital, Neurologische Klinik der Ruhruniversitat Bochum, Bochurn

48335

Michigan Institute for Neurological Disorders, Farmington Hills

60200

Faculty Hospital Brno Bohunice, Brno

66160

University of Kansas Medical Center, Department of Neurology, Kansas City

68198

University of Nebraska Medical Center, Omaha

70852

Faculty Hospital Of Ostrava Poruba, Ostrava

75214

Texas Neurology, Dallas

85259

Mayo Clinic Scottsdale, Scottsdale

87131

CMRRC, Albuquerque

94705

East Bay Region Associates in Neurology, Berkeley

98195

University of Washington MS Research Center, Seattle

95817-2307

UC Davis School of Medicine, Department of Neurology, Davis

06510

Yale University School of Medicine, Department of Neurology, New Haven

07666

Gimbel MS Center, Teaneck

97201-3098

Oregon Health Sciences University, Department of Neurology, Portland

V6T 2B5

Vancouver Hospital and Health Sciences Center UBC Pavilion, MS Clinical Research Group, Vancouver

R3A 1R9

Health Services Centre, Winnipeg

K7L 2V7

Kingston General Hospital, Neurology, Kingston

N6A 5A5

University Hospital, London

M4N 3M5

Sunnybrook and Women's College and Health Science Centre, Toronto

M5B 1W8

University of Toronto, MS Clinic, St. Michael's Hospital, Toronto

J8Y 1W7

CHVO Hull Hospital, Québec

B3H 1V7

MS Research Unit, Center for Clinical Research, Halifax

K1N 5C7

Family Medical Centre, Ottawa

656 91

Faculty Hospital St. Anne, Brno

500 05

Faculty Hospital of Hradec Kralove, Hradec Králové

775 20

Faculty Hospital Olomouc, Olomouc

532 03

Hospital Pardubice - Department of Neurology, Pardubice

304 60

Faculty Hospital Plzen - Clinic of Neurology, Pilsen

2 12802

General Teaching Hospital - Neurological Department, Prague

5 105 06

Faculty Hospital Motol - Neurological Clinic, Prague

85-681

Klinika Neurologii, Bydgoszcz

1081 HV

Academisch Ziekenhuis VU, Amsterdam

WC1N 3BG

Institute of Neurology, Queen Square

E1 1BB

The Royal London Hospital, Whitechapel

SW20 0NE

Atkin's Morely Hospital, Wimbledon

NE1 4LP

Oldchurch Hospital, Essex

Royal Victoria Infirmary, Newcastle upon Tyne

IP4 5PD

Ipswich Hospital NHS Trust - Department of Clinical Neurology, Ipswich

LS9 7TF

St. James University Hospital, Department of Neurology, Leeds

SE1 9RT

Guy's Hospital, London

SE5 9RS

King's College Hospital, London

Kings College Hospital, Kings Neuroscience Center, London

OX2 0HE

The Radcliffe Infirmary, University Department of Clinical Neurology, Oxford

S10 2JF

Royal Hallamshire Hospital, Sheffield

ST4 7LN

North Staffordshire Royal Infirmary - Neurology Department, Stoke-on-Trent

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Elan Pharmaceuticals

INDUSTRY

lead

Biogen

INDUSTRY