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).
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).
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.
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There are 100 Locations for this study
Birmingham Alabama, 35249, United States
Cullman Alabama, 35058, United States
Mobile Alabama, 36693, United States
Phoenix Arizona, 85013, United States
Berkeley California, 94705, United States
Irvine California, 92697, United States
Los Angeles California, 90048, United States
Oceanside California, 92056, United States
Pasadena California, 91105, United States
Sacramento California, 95817, United States
San Francisco California, 94117, United States
Denver Colorado, 80262, United States
Danbury Connecticut, 06810, United States
Fairfield Connecticut, 06824, United States
New Haven Connecticut, 06510, United States
Washington District of Columbia, 20007, United States
Hollywood Florida, 33021, United States
Jacksonville Florida, 32209, United States
Maitland Florida, 32751, United States
Miami Florida, 33136, United States
Pompano Beach Florida, 33060, United States
Sarasota Florida, 34243, United States
Sunrise Florida, 33351, United States
Tallahassee Florida, 32308, United States
Tampa Florida, 33609, United States
Vero Beach Florida, 32960, United States
Atlanta Georgia, 30327, United States
Augusta Georgia, 30912, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Elk Grove Village Illinois, 60007, United States
Flossmoor Illinois, 60402, United States
Palos Heights Illinois, 60453, United States
Fort Wayne Indiana, 46805, United States
Indianapolis Indiana, 46202, United States
Des Moines Iowa, 50314, United States
Kansas City Kansas, 66160, United States
Lenexa Kansas, 66214, United States
Louisville Kentucky, 40202, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21287, United States
Brighton Massachusetts, 02135, United States
Newton Massachusetts, 02462, United States
Springfield Massachusetts, 01104, United States
Worchester Massachusetts, 01605, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
East Lansing Michigan, 48824, United States
Grand Rapids Michigan, 49525, United States
St. Clair Shores Michigan, 48080, United States
Kansas City Missouri, 64111, United States
St. Louis Missouri, 63110, United States
Reno Nevada, 85902, United States
Lebanon New Hampshire, 03756, United States
Teaneck New Jersey, 07666, United States
Albuquerque New Mexico, 87131, United States
Latham New York, 12110, United States
New York New York, 10003, United States
New York New York, 10021, United States
New York New York, 10029, United States
Plainview New York, 11803, United States
Rochester New York, 14642, United States
Staten Island New York, 10306, United States
Stony Brook New York, 11794, United States
Syracuse New York, 13210, United States
Chapel Hill North Carolina, 27599, United States
Durham North Carolina, 27705, United States
Raleigh North Carolina, 27607, United States
Winston-Salem North Carolina, 27157, United States
Akron Ohio, 44302, United States
Bellevue Ohio, 44811, United States
Canton Ohio, 44718, United States
Cincinnati Ohio, 45219, United States
Columbus Ohio, 48221, United States
Toledo Ohio, 43614, United States
Uniontown Ohio, 44685, United States
Oklahoma City Oklahoma, 73120, United States
Tulsa Oklahoma, 74137, United States
Tualatin Oregon, 97062, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Pittsburgh Pennsylvania, 15212, United States
Pittsburgh Pennsylvania, 15213, United States
Greenville South Carolina, 29615, United States
Bristol Tennessee, 37620, United States
Nashville Tennessee, 37205, United States
Nashville Tennessee, 37212, United States
Houston Texas, 77030, United States
Lubbock Texas, 79410, United States
San Antonio Texas, 78231, United States
Burlington Vermont, 05401, United States
Charlottesville Virginia, 22903, United States
Seattle Washington, 98111, United States
Seattle Washington, 98122, United States
Morgantown West Virginia, 26506, United States
Madison Wisconsin, 53715, United States
Madison Wisconsin, 53792, United States
Milwaukee Wisconsin, 53215, United States
North Gosford New South Wales, , Australia
Vienna , , Austria
Ottawa Ontario, , Canada
Greenfield Park Quebec, , Canada
Bialystok , , Poland
Warsaw , , Poland
Warszawa , , Poland
Bucharest , , Romania
Targu Mures , , Romania
Istanbul , , Turkey
Izmir , , Turkey
Yenisehir/Izmir , , Turkey
Bristol , , United Kingdom
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