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 1080 people with relapsing-remitting multiple sclerosis.
This large-scale, Phase 3 study involves more than 95 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 FTY720 (fingolimod) vs. placebo, administered orally, once daily.
Rationale: As summarized in a National MS Society research bulletin dated September 2006, oral FTY720 significantly reduced signs of inflammation on MRI scans in a Phase 2, placebo-controlled clinical trial involving 281 people with active, relapsing MS. FTY720 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), 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 relapses, inflammatory disease activity, as measured on MRI scans, and time to progression of disability.
Participants will be randomly assigned to receive 0.5 mg/day FTY720, 1.25 mg/day FTY720 or placebo. Those who receive the study drug will do so at no cost. Study participation involves 12 study visits at intervals of no more than 3 months for 2 years; 1 screening, baseline and follow-up visit; and MRI exams at screening, months 6, 12, 24 and follow-up.
Patients who complete the 24-month double-blind treatment phase will be eligible to enter a long-term extension study (provided no exclusionary safety concerns arise), during which all patients will receive FTY720 at no cost.
For further details about the Phase 3 clinical trial, please see the fingolimod study Web site (www.msclinicaltrials.com/).
States (cities) where participants are being recruited are listed below:
California (Irvine, Berkeley, Oceanside, Sacramento, San Francisco, Pasadena, Los Angeles)
-- Research & Clinical Programs