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Summary: Investigators across the United States are enrolling participants in a clinical trial evaluating the safety and effectiveness of a once-a-day pill called fingolimod (also known as FTY720, by Novartis Pharmaceuticals Corp.) compared to inactive placebo in 960 people with relapsing-remitting multiple sclerosis.
This large-scale, Phase 3 study will eventually involve more than 100 centers in the United States. The study is called FREEDOMS II (FTY720 Research Evaluating Effects of Daily Oral therapy in MS). This 24-month study is comparing the safety and effectiveness of two different doses of fingolimod or inactive placebo administered orally once daily.
Rationale: As summarized in a National MS Society research bulletin dated September 2006, oral fingolimod significantly reduced signs of inflammation on MRI scans in a Phase 2 controlled clinical trial involving 255 people with active, relapsing MS. Fingolimod binds to a docking site (sphingosine-1-phosphate receptor, or S1P receptor) on immune cells, including T cells and B cells, that have been implicated in causing nervous system damage in MS. The drug appears to induce immune cells to remain in lymph nodes, where they can do little harm, preventing them from migrating into the brain and spinal cord. The Phase 2 results were published by Ludwig Kappos, MD (University Hospital, Basel, Switzerland) and colleagues in The New England Journal of Medicine (2006;355(11):1124-1139).
Eligibility and Details: To be considered for participation in the 24-month study, individuals must be 18-55 years of age with definite relapsing-remitting MS (a course of MS characterized by clearly defined flare-ups followed by partial or complete recovery periods), with at least one documented relapse during the previous year or two documented relapses during the previous two years. There are other specific inclusion criteria.
The primary outcome that will be measured is the reduction of relapse rate, and secondary outcomes will include frequency of relapse, disease activity on MRI scans, and time to progression of disability. For further details about the Phase 3 clinical trial, please see the fingolimod study Web site (www.msclinicaltrials.com/).
States where participants are being recruited are listed below:
Alabama
Arizona
California
Connecticut
Florida
Georgia
Illinois
Indiana
Iowa
Kansas
Maryland
Massachusetts
Michigan
Missouri
Nevada
New Jersey
New York
North Carolina
Ohio
Pennsylvania
South Carolina
Virginia
Tennessee
Texas
Vermont
Washington
Wisconsin
-- Research & Clinical Programs |