Multiple Sclerosis Clinical Trial

Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis

Summary

This study assessed the safety, tolerability and efficacy of two doses of oral fingolimod compared to placebo on efficacy parameters in patients with relapsing-remitting multiple sclerosis (RRMS).

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Full Description

This randomized, multicenter, parallel-group study consisted of 2 phases: a 24-month double-blind, randomized, multicenter, placebo-controlled, parallel-group study and an Extension phase which consisted of a dose-blinded period and an open-label period.

In the Core phase, patients were randomized to receive a fixed dose of fingolimod (0.5 mg/day), fingolimod (1.25 mg/day) or placebo for up to 24 months.

For the Extension phase, patients who were treated with fingolimod during the Core phase continued treatment at the assigned dose level, while those previously treated with placebo during the Core phase were re-randomized in a 1:1 ratio to receive one of the two doses of fingolimod (1.25 mg or 0.5 mg). All patients in the extension received blinded investigational drug: fingolimod 1.25 mg and 0.5 mg in capsules for oral administration once daily until the decision to discontinue the fingolimod 1.25 mg dose became effective and subsequently all patients were switched to open-label fingolimod 0.5 mg.

With the implementation of Amendment 11, the 1.25 mg dose was discontinued and all patients were switched to fingolimod 0.5 mg dose. With the implementation of Amendment 12, all patients treated with Placebo in the fingolimod Core phase were switched to treatment with 0.5 mg fingolimod per day. The Extension phase continued until all patients either discontinued or transferred to Study CFTY720D2399 (NCT01201356; initiated in September 2010).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis
Patients with a relapsing-remitting disease course
Patients with expanded disability status scale (EDSS) score of 0-5.5

Exclusion Criteria:

Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.
Pregnant or nursing women

For inclusion in the extension phase patients should complete the 24 month core study with or without 24 months on study drug. If a patient discontinued study drug during the core study due to an adverse event, serious adverse event, laboratory abnormality etc. they would be excluded from the Extension Phase.

Other protocol-defined inclusion/exclusion criteria may apply.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1083

Study ID:

NCT00355134

Recruitment Status:

Completed

Sponsor:

Novartis

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There are 100 Locations for this study

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University of Alabama Birmingham
Birmingham Alabama, 35249, United States
North Central Neurology Associates, PC
Cullman Alabama, 35058, United States
University of South Alabama - Dept of Neurology
Mobile Alabama, 36693, United States
Barrow Neurology Clinic
Phoenix Arizona, 85013, United States
Research and Education Institute of Alta Bates Summit Medical Center
Berkeley California, 94705, United States
University of California - Irvine, Deptarment of Neurology
Irvine California, 92697, United States
Cedars Sinai Medical Center
Los Angeles California, 90048, United States
The Neurology Center
Oceanside California, 92056, United States
Neuro-Therapeutics, Inc.
Pasadena California, 91105, United States
UC Davis Medical Center
Sacramento California, 95817, United States
Multiple Sclerosis Center at UCSF
San Francisco California, 94117, United States
University of Colorado
Denver Colorado, 80262, United States
Associated Neurologists, PC
Danbury Connecticut, 06810, United States
Associated Neurologists of Southern CT, P.C.
Fairfield Connecticut, 06824, United States
Yale University - Yale Multiple Sclerosis Center
New Haven Connecticut, 06510, United States
Georgetown University Hospital - Dept of Neurology
Washington District of Columbia, 20007, United States
Sunrise Clinical Research, Inc.
Hollywood Florida, 33021, United States
University of Florida Health Sciences Center/Shands Jacksonville
Jacksonville Florida, 32209, United States
Neurology Associates, PA
Maitland Florida, 32751, United States
University of Miami, Department of Neurology
Miami Florida, 33136, United States
Neurological Associates
Pompano Beach Florida, 33060, United States
Roskamp Institute, Clinical Trials Division
Sarasota Florida, 34243, United States
Neurology Clinical Research, Inc
Sunrise Florida, 33351, United States
AMO Corporation
Tallahassee Florida, 32308, United States
Axiom Clinical Research of Florida
Tampa Florida, 33609, United States
The MS Center of Vero Beach
Vero Beach Florida, 32960, United States
MS Center of Atlanta
Atlanta Georgia, 30327, United States
Medical College of Georgia
Augusta Georgia, 30912, United States
Northwestern University Medical School - Dept of Neurology
Chicago Illinois, 60611, United States
Rush University Medical Center Department of Neurological Sciences
Chicago Illinois, 60612, United States
University of Chicago - Dept of Neurology
Chicago Illinois, 60637, United States
Alexian Brothers Neurosciences Research
Elk Grove Village Illinois, 60007, United States
South Suburban Neurology
Flossmoor Illinois, 60402, United States
Neurologic Associates, Ltd.
Palos Heights Illinois, 60453, United States
Fort Wayne Neurological Center
Fort Wayne Indiana, 46805, United States
Indiana University Medical Center
Indianapolis Indiana, 46202, United States
Ruan Neurology Clinical Research Center
Des Moines Iowa, 50314, United States
University of Kansas Medical Center
Kansas City Kansas, 66160, United States
Mid America Neuroscience Institute
Lenexa Kansas, 66214, United States
Kentucky Research Associates
Louisville Kentucky, 40202, United States
University of Maryland
Baltimore Maryland, 21201, United States
Johns Hopkins MS Center
Baltimore Maryland, 21287, United States
Caritas St. Elizabeth's Medical Center
Brighton Massachusetts, 02135, United States
Newton Wesley Hospital
Newton Massachusetts, 02462, United States
Springfield Neurology
Springfield Massachusetts, 01104, United States
UMass Memorial Medical Center
Worchester Massachusetts, 01605, United States
University of Michigan Mulitiple Sclerosis Clinic
Ann Arbor Michigan, 48109, United States
Wayne State University MS Clinic
Detroit Michigan, 48201, United States
Henry Ford Hospital, Department of Neurology
Detroit Michigan, 48202, United States
Michigan State University MS Clinic
East Lansing Michigan, 48824, United States
Michigan Medical, P.C.
Grand Rapids Michigan, 49525, United States
Michigan Neurology Associates, PC
St. Clair Shores Michigan, 48080, United States
St. Luke's Hospital - Mid-America Brain and Stroke Institute
Kansas City Missouri, 64111, United States
The MS Center for Innovation in Care
St. Louis Missouri, 63110, United States
Institute for Neurosciences
Reno Nevada, 85902, United States
Multiple Sclerosis Center
Lebanon New Hampshire, 03756, United States
Gimbel Multiple Sclerosis Center at Holy Name Hospital
Teaneck New Jersey, 07666, United States
University of New Mexico Health Science Center
Albuquerque New Mexico, 87131, United States
Empire Neurology, PC
Latham New York, 12110, United States
NYU Hospital for Joint Diseases
New York New York, 10003, United States
Cornell University - NY Presbyterian Hospital
New York New York, 10021, United States
Mount Sinai School of Medicine
New York New York, 10029, United States
Island Neurological Associates, PC
Plainview New York, 11803, United States
University of Rochester Medical Center
Rochester New York, 14642, United States
Alpha Neurology
Staten Island New York, 10306, United States
SUNY Stony Brook
Stony Brook New York, 11794, United States
SUNY Upstate Medical University
Syracuse New York, 13210, United States
UNC - Chapel Hill Neuroscience Hospital
Chapel Hill North Carolina, 27599, United States
Duke University Medical Center
Durham North Carolina, 27705, United States
Raleigh Neurology Associates
Raleigh North Carolina, 27607, United States
Wake Forest University Baptist Medical Center
Winston-Salem North Carolina, 27157, United States
Neurology & Neuroscience Associates, Inc.
Akron Ohio, 44302, United States
Northern Ohio Neuroscience, LLC.
Bellevue Ohio, 44811, United States
NeuroCare Center, Inc
Canton Ohio, 44718, United States
River Hills Health Care
Cincinnati Ohio, 45219, United States
Ohio State University
Columbus Ohio, 48221, United States
University of Toledo Health Science Campus
Toledo Ohio, 43614, United States
Oak Clinic
Uniontown Ohio, 44685, United States
MS Center of Oklahoma, Mercy Neuroscience Institute
Oklahoma City Oklahoma, 73120, United States
Neurologial Associates of Tulsa
Tulsa Oklahoma, 74137, United States
Oregon Neurology
Tualatin Oregon, 97062, United States
University of Pennsylvania, Department of Neurology
Philadelphia Pennsylvania, 19104, United States
Thomas Jefferson University Hospital, Department of Neurology
Philadelphia Pennsylvania, 19107, United States
Allegheny Neurological Associates
Pittsburgh Pennsylvania, 15212, United States
University of Pittsburgh - Dept of Neurology
Pittsburgh Pennsylvania, 15213, United States
Absher Neurology
Greenville South Carolina, 29615, United States
Mountain Empire Neurological Associates, PC
Bristol Tennessee, 37620, United States
Advanced Neurosciences Institute
Nashville Tennessee, 37205, United States
Vanderbilt Stallworth Rehabilitation Hospital
Nashville Tennessee, 37212, United States
University of Texas - Houston Medical School
Houston Texas, 77030, United States
Investigational Site - Private Practice
Lubbock Texas, 79410, United States
Integra Clinical Research, LLC
San Antonio Texas, 78231, United States
Neurology Health Care Service - Fletcher Allen Hospital
Burlington Vermont, 05401, United States
University of Virginia - Fontaine Adult Neurology
Charlottesville Virginia, 22903, United States
Virginia Mason Multiple Sclerosis Center
Seattle Washington, 98111, United States
Seattle Neuroscience Institute at Swedish Medical Center
Seattle Washington, 98122, United States
University Health Associates - West Virgina University
Morgantown West Virginia, 26506, United States
Dean Foundation
Madison Wisconsin, 53715, United States
University of Wisconsin Medical School
Madison Wisconsin, 53792, United States
St. Luke's Medical Center
Milwaukee Wisconsin, 53215, United States
Novartis Investigative Site
North Gosford New South Wales, , Australia
Novartis Investigative Site
Vienna , , Austria
Novartis Investigative Site
Ottawa Ontario, , Canada
Novartis Investigative Site
Greenfield Park Quebec, , Canada
Novartis Investigative Site
Bialystok , , Poland
Novartis Investigative Site
Warsaw , , Poland
Novartis Investigative Site
Warszawa , , Poland
Novartis Investigative Site
Bucharest , , Romania
Novartis Investigative Site
Targu Mures , , Romania
Novartis Investigative Site
Istanbul , , Turkey
Novartis Investigative Site
Izmir , , Turkey
Novartis Investigative Site
Yenisehir/Izmir , , Turkey
Novartis Investigative Site
Bristol , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1083

Study ID:

NCT00355134

Recruitment Status:

Completed

Sponsor:


Novartis

How clear is this clinincal trial information?

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