Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase

Completed · Phase 3 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

This study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod versus interferon β-1a to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis.

Key facts

Study ID

NCT00340834

Run by

Novartis

People needed

1292

Starts

2006-05-01

Expected to finish

2011-07-01

Last updated by the study team

2017-09-21

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis (MS)
• Patients with a relapsing-remitting disease course
• Patients with Expanded Disability Status Scale (EDSS) score of 0-5.5

You may not qualify if…

• Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc
• Pregnant or nursing women
• Patients who cannot tolerate treatment with an interferon
• Other protocol-defined inclusion/exclusion criteria applied to the study.

Where it is running

• Barrow Neurological Institute — Phoenix, Arizona, United States
• The Neurology Center, 3907 Waring Road, Suite 3 — Oceanside, California, United States
• Associated Neurologists, PC, 69 Sand Pit Road, Suite 300 — Danbury, Connecticut, United States
• Associated Neurologists of Southern CT, PC, 75 Kings Highway Cutoff — Fairfield, Connecticut, United States
• Yale University Multiple Sclerosis Center — New Haven, Connecticut, United States
• University of Florida Health Science Center — Jacksonville, Florida, United States
• Neurology Associates, PA, 301 N. Maitland Avenue, Suite A1 — Maitland, Florida, United States
• University of Miami, Department of Neurology — Miami, Florida, United States
• Neurological Associates — Pompano Beach, Florida, United States
• Roskamp Institute, 2040 Whitfield Ave. — Sarasota, Florida, United States
• AMO Corporation — Tallahassee, Florida, United States
• Axiom Clinical Research of Florida, 2919 Swann Avenue, Suite 401 — Tampa, Florida, United States
• University of South Florida, Department of Neurology — Tampa, Florida, United States
• The MS Center of Vero Beach — Vero Beach, Florida, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Mid America Neuroscience Institute, 8550 Marshall Drive, Suite 100 — Lenexa, Kansas, United States
• University Physician Group, #1 Barnes-Jewish Hospital Plaza, Suite 16304 — St Louis, Missouri, United States
• Neuroscience and Spine Center — Charlotte, North Carolina, United States
• Raleigh Neurology Associates, 1540 Sunday Drive — Raleigh, North Carolina, United States
• Neurology & Neuroscience Associates, Inc — Akron, Ohio, United States
• Northern Ohio Neuroscience, LLC — Bellevue, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Oregon Neurology — Tualatin, Oregon, United States
• University of Pittsburgh, Department of Neurology — Pittsburgh, Pennsylvania, United States
• North Central Neurology Associates, PC, 1809 Kress Street — Cullman, Alabama, United States

Full record on ClinicalTrials.gov

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