Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis

Completed · Phase 3 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

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).

Key facts

Study ID

NCT00355134

Run by

Novartis

People needed

1083

Starts

2006-06-01

Expected to finish

2011-08-01

Last updated by the study team

2012-08-07

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
• 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
• 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.

Where it is running

• 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
• University of Alabama Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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