Long Term Study of Fingolimod in MS Patients From the FTY Clinical Program

Completed

Conditions studied: Multiple Sclerosis

In brief

The purpose of this observational study is to collect long-term data on safety and effectiveness of fingolimod, particularly including clinical disease and patient outcome related parameters such as relapse and disability, in patients who have participated in prior trials within the fingolimod clinical development program. Furthermore, this study explores the incidence of selected safety related outcomes of fingolimod treatment during follow-up visits within the context of routine medical practice.

Key facts

Study ID

NCT01281657

Run by

Novartis

People needed

64

Starts

2011-02-01

Expected to finish

2012-07-01

Last updated by the study team

2012-09-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who are prescribed fingolimod as part of their routine medical care
• Patients who have participated in a prior fingolimod clinical trials

You may not qualify if…

• Restrictions regarding the use of fingolimod while pregnant or nursing in accordance with the local prescribing label
• Any patient who has prematurely discontinued from the previous fingolimod trial
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• The Research & Education Inst. of Alta Bates Summit Med. Grp — Berkeley, California, United States
• Neuro-Therapeutics, Inc. — Pasadena, California, United States
• University of California San Francisco — San Francisco, California, United States
• Yale Multiple Sclerosis Center — New Haven, Connecticut, United States
• Georgetown University/Lombardi Cancer Center — Washington D.C., District of Columbia, United States
• Sunrise Clinical Research, Inc. — Hollywood, Florida, United States
• University of Florida — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• Neurological Associates — Pompano Beach, Florida, United States
• Neurology Clinical Research, Inc. — Sunrise, Florida, United States
• AMO Corporation — Tallahassee, Florida, United States
• MS Center of Vero Beach — Vero Beach, Florida, United States
• South Suburban Neurology — Flossmoor, Illinois, United States
• Neurologic Associates, LTD — Palos Heights, Illinois, United States
• Mercy Ruan Neurology Clinic Res Ct. — Des Moines, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Mid America Neuroscience Institute — Lenexa, Kansas, United States
• University of Maryland — Baltimore, Maryland, United States
• Johns Hopkins MS Center — Baltimore, Maryland, United States
• Caritas St. Elizabeth's Hospital — Boston, Massachusetts, United States
• Springfield Neurology Associates, LLC — Springfield, Massachusetts, United States
• Spectrum Health Medical Group, Neurology — Grand Rapids, Michigan, United States
• Saint Luke's Hospital — Kansas City, Missouri, United States
• The MS Center for Innovation in Care — St Louis, Missouri, United States
• North Central Neurology Associates, PC — Cullman, Alabama, United States

Full record on ClinicalTrials.gov

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