Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
NCT ID: NCT00355134
Last Updated: 2012-08-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
1083 participants
INTERVENTIONAL
2006-06-30
2011-08-31
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Fingolimod 1.25 mg
Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally once a day.
Note: Upon implementation of a protocol amendment all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
Fingolimod
Fingolimod capsules for oral administration
Fingolimod 0.5 mg
Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
Fingolimod
Fingolimod capsules for oral administration
Placebo
Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day.
Note: Upon implementation of a protocol amendment all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
Placebo
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Interventions
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Fingolimod
Fingolimod capsules for oral administration
Placebo
Matching placebo capsules for oral administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with a relapsing-remitting disease course
* Patients with expanded disability status scale (EDSS) score of 0-5.5
Exclusion Criteria
* 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.
18 Years
55 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_CHAIR
Novartis Pharmaceuticals
Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
North Central Neurology Associates, PC
Cullman, Alabama, United States
University of South Alabama - Dept of Neurology
Mobile, Alabama, United States
Barrow Neurology Clinic
Phoenix, Arizona, United States
Research and Education Institute of Alta Bates Summit Medical Center
Berkeley, California, United States
University of California - Irvine, Deptarment of Neurology
Irvine, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
The Neurology Center
Oceanside, California, United States
Neuro-Therapeutics, Inc.
Pasadena, California, United States
UC Davis Medical Center
Sacramento, California, United States
Multiple Sclerosis Center at UCSF
San Francisco, California, United States
University of Colorado
Denver, Colorado, United States
Associated Neurologists, PC
Danbury, Connecticut, United States
Associated Neurologists of Southern CT, P.C.
Fairfield, Connecticut, United States
Yale University - Yale Multiple Sclerosis Center
New Haven, Connecticut, United States
Georgetown University Hospital - Dept of Neurology
Washington D.C., District of Columbia, United States
Sunrise Clinical Research, Inc.
Hollywood, Florida, United States
University of Florida Health Sciences Center/Shands Jacksonville
Jacksonville, Florida, United States
Neurology Associates, PA
Maitland, Florida, United States
University of Miami, Department of Neurology
Miami, Florida, United States
Neurological Associates
Pompano Beach, Florida, United States
Roskamp Institute, Clinical Trials Division
Sarasota, Florida, United States
Neurology Clinical Research, Inc
Sunrise, Florida, United States
AMO Corporation
Tallahassee, Florida, United States
Axiom Clinical Research of Florida
Tampa, Florida, United States
The MS Center of Vero Beach
Vero Beach, Florida, United States
MS Center of Atlanta
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
Northwestern University Medical School - Dept of Neurology
Chicago, Illinois, United States
Rush University Medical Center Department of Neurological Sciences
Chicago, Illinois, United States
University of Chicago - Dept of Neurology
Chicago, Illinois, United States
Alexian Brothers Neurosciences Research
Elk Grove Village, Illinois, United States
South Suburban Neurology
Flossmoor, Illinois, United States
Neurologic Associates, Ltd.
Palos Heights, Illinois, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
Indiana University Medical Center
Indianapolis, Indiana, United States
Ruan Neurology Clinical Research Center
Des Moines, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Mid America Neuroscience Institute
Lenexa, Kansas, United States
Kentucky Research Associates
Louisville, Kentucky, United States
University of Maryland
Baltimore, Maryland, United States
Johns Hopkins MS Center
Baltimore, Maryland, United States
Caritas St. Elizabeth's Medical Center
Brighton, Massachusetts, United States
Newton Wesley Hospital
Newton, Massachusetts, United States
Springfield Neurology
Springfield, Massachusetts, United States
UMass Memorial Medical Center
Worchester, Massachusetts, United States
University of Michigan Mulitiple Sclerosis Clinic
Ann Arbor, Michigan, United States
Wayne State University MS Clinic
Detroit, Michigan, United States
Henry Ford Hospital, Department of Neurology
Detroit, Michigan, United States
Michigan State University MS Clinic
East Lansing, Michigan, United States
Michigan Medical, P.C.
Grand Rapids, Michigan, United States
Michigan Neurology Associates, PC
Saint Clair Shores, Michigan, United States
St. Luke's Hospital - Mid-America Brain and Stroke Institute
Kansas City, Missouri, United States
The MS Center for Innovation in Care
St Louis, Missouri, United States
Institute for Neurosciences
Reno, Nevada, United States
Multiple Sclerosis Center
Lebanon, New Hampshire, United States
Gimbel Multiple Sclerosis Center at Holy Name Hospital
Teaneck, New Jersey, United States
University of New Mexico Health Science Center
Albuquerque, New Mexico, United States
Empire Neurology, PC
Latham, New York, United States
NYU Hospital for Joint Diseases
New York, New York, United States
Cornell University - NY Presbyterian Hospital
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Island Neurological Associates, PC
Plainview, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Alpha Neurology
Staten Island, New York, United States
SUNY Stony Brook
Stony Brook, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
UNC - Chapel Hill Neuroscience Hospital
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Raleigh Neurology Associates
Raleigh, North Carolina, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Neurology & Neuroscience Associates, Inc.
Akron, Ohio, United States
Northern Ohio Neuroscience, LLC.
Bellevue, Ohio, United States
NeuroCare Center, Inc
Canton, Ohio, United States
River Hills Health Care
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
University of Toledo Health Science Campus
Toledo, Ohio, United States
Oak Clinic
Uniontown, Ohio, United States
MS Center of Oklahoma, Mercy Neuroscience Institute
Oklahoma City, Oklahoma, United States
Neurologial Associates of Tulsa
Tulsa, Oklahoma, United States
Oregon Neurology
Tualatin, Oregon, United States
University of Pennsylvania, Department of Neurology
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital, Department of Neurology
Philadelphia, Pennsylvania, United States
Allegheny Neurological Associates
Pittsburgh, Pennsylvania, United States
University of Pittsburgh - Dept of Neurology
Pittsburgh, Pennsylvania, United States
Absher Neurology
Greenville, South Carolina, United States
Mountain Empire Neurological Associates, PC
Bristol, Tennessee, United States
Advanced Neurosciences Institute
Nashville, Tennessee, United States
Vanderbilt Stallworth Rehabilitation Hospital
Nashville, Tennessee, United States
University of Texas - Houston Medical School
Houston, Texas, United States
Investigational Site - Private Practice
Lubbock, Texas, United States
Integra Clinical Research, LLC
San Antonio, Texas, United States
Neurology Health Care Service - Fletcher Allen Hospital
Burlington, Vermont, United States
University of Virginia - Fontaine Adult Neurology
Charlottesville, Virginia, United States
Virginia Mason Multiple Sclerosis Center
Seattle, Washington, United States
Seattle Neuroscience Institute at Swedish Medical Center
Seattle, Washington, United States
University Health Associates - West Virgina University
Morgantown, West Virginia, United States
Dean Foundation
Madison, Wisconsin, United States
University of Wisconsin Medical School
Madison, Wisconsin, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 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
Bucharest, , Romania
Novartis Investigative Site
Târgu Mureş, , Romania
Novartis Investigative Site
Istanbul, , Turkey (Türkiye)
Novartis Investigative Site
Izmir, , Turkey (Türkiye)
Novartis Investigative Site
Yenisehir/Izmir, , Turkey (Türkiye)
Novartis Investigative Site
Bristol, , United Kingdom
Countries
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References
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Wang L, Tan H, Yu J, ZhangBao J, Huang W, Chang X, Zhou L, Lu C, Xiao Y, Lu J, Zhao C, Wang M, Wu X, Wu M, Dong Q, Ngew KY, Quan C. Baseline retinal nerve fiber layer thickness as a predictor of multiple sclerosis progression: New insights from the FREEDOMS II study. Eur J Neurol. 2023 Feb;30(2):443-452. doi: 10.1111/ene.15612. Epub 2022 Nov 15.
Fox RJ, Chan A, Zhang A, Xiao J, Levison D, Lewin JB, Edwards MR, Marantz JL. Comparative effectiveness using a matching-adjusted indirect comparison between delayed-release dimethyl fumarate and fingolimod for the treatment of multiple sclerosis. Curr Med Res Opin. 2017 Feb;33(2):175-183. doi: 10.1080/03007995.2016.1248380. Epub 2016 Nov 10.
Derfuss T, Bergvall NK, Sfikas N, Tomic DL. Efficacy of fingolimod in patients with highly active relapsing-remitting multiple sclerosis. Curr Med Res Opin. 2015;31(9):1687-91. doi: 10.1185/03007995.2015.1067191. Epub 2015 Aug 20.
Chinea Martinez AR, Correale J, Coyle PK, Meng X, Tenenbaum N. Efficacy and safety of fingolimod in Hispanic patients with multiple sclerosis: pooled clinical trial analyses. Adv Ther. 2014 Oct;31(10):1072-81. doi: 10.1007/s12325-014-0154-4. Epub 2014 Sep 23.
Calabresi PA, Radue EW, Goodin D, Jeffery D, Rammohan KW, Reder AT, Vollmer T, Agius MA, Kappos L, Stites T, Li B, Cappiello L, von Rosenstiel P, Lublin FD. Safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis (FREEDOMS II): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2014 Jun;13(6):545-56. doi: 10.1016/S1474-4422(14)70049-3. Epub 2014 Mar 28.
Winges KM, Werner JS, Harvey DJ, Cello KE, Durbin MK, Balcer LJ, Calabresi PA, Keltner JL. Baseline retinal nerve fiber layer thickness and macular volume quantified by OCT in the North American phase 3 fingolimod trial for relapsing-remitting multiple sclerosis. J Neuroophthalmol. 2013 Dec;33(4):322-9. doi: 10.1097/WNO.0b013e31829c51f7.
Related Links
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Fingolimod clinical trials information website
Other Identifiers
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CFTY720D2309
Identifier Type: -
Identifier Source: org_study_id
NCT00774670
Identifier Type: -
Identifier Source: nct_alias