Multiple Sclerosis Clinical Trial

Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies

Summary

The purpose of this world-wide prospective parallel-cohort study in patients with relapsing forms of MS, either newly treated with fingolimod or receiving another disease-modifying therapy, is to further explore the incidence of selected safety- related outcomes and to further monitor the overall safety profile of fingolimod under conditions of routine medical practice.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients that as part of their routine clinical care and according to the locally approved label, are either;
Starting fingolimod at time of study entry.
Starting another approved DMT or started within maximum 6 months prior to study entry.
Patients, or a able legal representative of the patient, who are willing to provide written informed consent.

Fingolimod patients will constitute the fingolimod cohort while patients with the other DMT will constitute the parallel cohort

Exclusion Criteria:

Patients previously or currently treated with a cytotoxic agent (e.g. mitoxantrone, cladribine, alemtuzumab) or natalizumab
Patients participating simultaneously in another study with inclusion/exclusion criteria more restrictive than the label or an interventional study unless this is a study on fingolimod lasting 1 month maximum

Other protocol-defined inclusion/exclusion criteria may apply

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

3076

Study ID:

NCT01442194

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 236 Locations for this study

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Novartis Investigative Site
Birmingham Alabama, 35209, United States
Novartis Investigative Site
Birmingham Alabama, 35233, United States
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Birmingham Alabama, 35235, United States
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Cullman Alabama, 35058, United States
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Mobile Alabama, 36617, United States
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Phoenix Arizona, 85013, United States
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Sottsdale Arizona, 85258, United States
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Tucson Arizona, 85718, United States
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Bakersfield California, 93311, United States
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Banning California, 92220, United States
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Burbank California, 91505, United States
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Fresno California, 93710, United States
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Fullerton California, 92835, United States
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Huntington Beach California, 92649, United States
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Irvine California, 92618, United States
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Loma Linda California, 92354, United States
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Los Angeles California, 90073, United States
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Newport Beach California, 92660, United States
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Oceanside California, 92056, United States
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Placentia California, 92870, United States
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Pomona California, 91767, United States
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Redding California, 96001, United States
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Santa Monica California, 90404, United States
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Temecula California, 92591, United States
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Aurora Colorado, 80045, United States
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Basalt Colorado, 81621, United States
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Colorado Springs Colorado, 80907, United States
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Denver Colorado, 80210, United States
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Fort Collins Colorado, 80524, United States
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Louisville Colorado, 80027, United States
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Parker Colorado, 80138, United States
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Fairfield Connecticut, 06824, United States
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Hartford Connecticut, 6112, United States
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Waterbury Connecticut, 06708, United States
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Dover Delaware, 19901, United States
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Newark Delaware, 19713, United States
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Washington District of Columbia, 20007, United States
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Washington District of Columbia, 20037, United States
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Bradenton Florida, 34205, United States
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Clermont Florida, 34711, United States
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Delray Beach Florida, 33445, United States
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Doral Florida, 33136, United States
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Hollywood Florida, 33021, United States
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Jupiter Florida, 33458, United States
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Maitland Florida, 32751, United States
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Miami Florida, 33032, United States
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Miami Florida, 33144, United States
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Miami Florida, 33155, United States
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Naples Florida, 34102, United States
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Orlando Florida, 32806, United States
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Ormond Beach Florida, 32174, United States
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Panama City Florida, 32405, United States
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Port Charlotte Florida, 33952, United States
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Sarasota Florida, 34233, United States
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Wellington Florida, 33414, United States
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West Palm Beach Florida, 33407, United States
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Weston Florida, 33331, United States
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Atlanta Georgia, 30309, United States
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Atlanta Georgia, 30327, United States
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Augusta Georgia, 30912, United States
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Macon Georgia, 31210, United States
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Suwanee Georgia, 30024, United States
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Arlington Heights Illinois, 60004, United States
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Carbondale Illinois, 62901, United States
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Flossmoor Illinois, 60422, United States
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Marywood Illinois, 60153, United States
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Peoria Illinois, 61637, United States
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Anderson Indiana, 46011, United States
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Indianapolis Indiana, 46227, United States
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Indianapolis Indiana, 46256, United States
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Lafayette Indiana, 47905, United States
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Merrillville Indiana, 46410, United States
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Des Moines Iowa, 50314, United States
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Kansas City Kansas, 66160, United States
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Lenexa Kansas, 66212, United States
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Overland Park Kansas, 66210, United States
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Topeka Kansas, 66606, United States
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Lexington Kentucky, 40503, United States
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Lexington Kentucky, 40513, United States
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Louisville Kentucky, 40202, United States
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Hammond Louisiana, 70403, United States
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Auburn Maine, 04210, United States
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Bangor Maine, 04401, United States
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Baltimore Maryland, 21201, United States
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Baltimore Maryland, 21209, United States
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Baltimore Maryland, 21212, United States
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Bethesda Maryland, 20814, United States
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Charlotte Hall Maryland, 20622, United States
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Hagerstown Maryland, 21741, United States
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Lutherville Maryland, 21093, United States
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Waldorf Maryland, 20603, United States
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Boston Massachusetts, 02135, United States
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Boston Massachusetts, 02215, United States
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Foxboro Massachusetts, 02035, United States
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Springfield Massachusetts, 01104, United States
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Wellesley Massachusetts, 02481, United States
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Worcester Massachusetts, 01608, United States
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Caro Michigan, 48723, United States
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Detroit Michigan, 48201, United States
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Jackson Michigan, 49201, United States
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Owosso Michigan, 48867, United States
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Rochester Hills Michigan, 48301, United States
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Southfield Michigan, 48034, United States
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Traverse City Michigan, 49684, United States
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Edina Minnesota, 55435, United States
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Golden Valley Minnesota, 55422, United States
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Saint Louis Missouri, 63104, United States
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Saint Louis Missouri, 63128, United States
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Saint Peters Missouri, 63303, United States
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Springfield Missouri, 65807, United States
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Great Falls Montana, 59405, United States
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Hastings Nebraska, 68901, United States
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Omaha Nebraska, 68198, United States
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Las Vegas Nevada, 89106, United States
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Lebanon New Hampshire, 03756, United States
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Fair Lawn New Jersey, 07410, United States
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Livingston New Jersey, 07039, United States
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Somerset New Jersey, 08873, United States
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West Long Branch New Jersey, 07764, United States
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Albany New York, 12208, United States
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Amherst New York, 14226, United States
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Bronx New York, 10467, United States
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Brooklyn New York, 11220, United States
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Cedarhurst New York, 11516, United States
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Johnson City New York, 13790, United States
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Kingston New York, 12401, United States
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Lake Success New York, 11042, United States
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New York New York, 10003, United States
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Patchogue New York, 11772, United States
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Plainview New York, 11803, United States
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Poughkeepsie New York, 12601, United States
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Staten Island New York, 10306, United States
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Syracuse New York, 13210, United States
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Asheville North Carolina, 28805, United States
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Asheville North Carolina, 28806, United States
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Chapel Hill North Carolina, 27599, United States
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Charlotte North Carolina, 28202, United States
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Charlotte North Carolina, 28204, United States
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Durham North Carolina, 27710, United States
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Hickory North Carolina, 28602, United States
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Raleigh North Carolina, 27607, United States
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Sanford North Carolina, 27330, United States
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Wilmington North Carolina, 28401, United States
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Bismarck North Dakota, 58501, United States
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Bellevue Ohio, 44811, United States
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Centerville Ohio, 45459, United States
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Cincinnati Ohio, 45219, United States
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Columbus Ohio, 43210, United States
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Columbus Ohio, 43221, United States
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Dayton Ohio, 45408, United States
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Toledo Ohio, 43614, United States
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Toledo Ohio, 43623, United States
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Oklahoma City Oklahoma, 73102, United States
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Oklahoma City Oklahoma, 73104, United States
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Portland Oregon, 97225, United States
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Springfield Oregon, 97477, United States
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Greensburg Pennsylvania, 15601, United States
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Meadowbrook Pennsylvania, 19046, United States
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Philadelphia Pennsylvania, 19107, United States
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Philadelphia Pennsylvania, 19107, United States
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Pittsburgh Pennsylvania, 15243, United States
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Willow Grove Pennsylvania, 19090, United States
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Beaufort South Carolina, 29902, United States
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Camden South Carolina, 29020, United States
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Charleston South Carolina, 29406, United States
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Greer South Carolina, 29650, United States
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Indian Land South Carolina, 29707, United States
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Mount Pleasant South Carolina, 29464, United States
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Spartanburg South Carolina, 29303, United States
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Spartanburg South Carolina, 29307, United States
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Knoxville Tennessee, 37922, United States
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Nashville Tennessee, 37205, United States
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Nashville Tennessee, 37212, United States
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Brownwood Texas, 76801, United States
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Dallas Texas, 75214, United States
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Dallas Texas, 75390, United States
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Houston Texas, 77005, United States
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Houston Texas, 77025, United States
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Kingwood Texas, 77339, United States
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Mansfield Texas, 76063, United States
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San Antonio Texas, 78229, United States
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Stafford Texas, 77477, United States
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Sugar Land Texas, 77479, United States
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Provo Utah, 84604, United States
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Salt Lake City Utah, 84103, United States
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Salt Lake City Utah, 84132, United States
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Alexandria Virginia, 22310, United States
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Arlington Virginia, 22205, United States
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Charlottesville Virginia, 22911, United States
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McLean Virginia, 22101, United States
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Newport News Virginia, 23601, United States
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Norfolk Virginia, 23507, United States
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Richmond Virginia, 23228, United States
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Richmond Virginia, 23924, United States
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Vienna Virginia, 22182, United States
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Winchester Virginia, 22601, United States
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Richland Washington, 99352, United States
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Spokane Washington, 99208, United States
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Tacoma Washington, 98405, United States
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Wenatchee Washington, 98801, United States
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Beckley West Virginia, 25801, United States
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Huntington West Virginia, 25701, United States
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Green Bay Wisconsin, 54311, United States
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Milwaukee Wisconsin, 53211, United States
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Monroe Wisconsin, 53566, United States
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Neenah Wisconsin, 54956, United States
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Wisconsin Rapids Wisconsin, 54495, United States
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Casper Wyoming, 82601, United States
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Jenin Buenos Aires, 6000, Argentina
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San Miguel de Tucuman Tucuman, T4000, Argentina
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Buenos Aires , 1061, Argentina
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Ciudad Autonoma de Bs As , , Argentina
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Cordoba , X5004, Argentina
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Salta , A4400, Argentina
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Kogarah New South Wales, 2217, Australia
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Box Hill Victoria, 3128, Australia
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Melbourne Victoria, 3004, Australia
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Parkville Victoria, 3050, Australia
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Edmonton Alberta, T6G 2, Canada
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Saint John New Brunswick, E2L 4, Canada
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Halifax Nova Scotia, B3H 4, Canada
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Guelph Ontario, N1H 4, Canada
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Kingston Ontario, K7L 2, Canada
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Ottawa Ontario, K1H 8, Canada
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St. Catharine's Ontario, L2R 2, Canada
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Chicoutimi Quebec, G7H 5, Canada
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Montreal Quebec, H1T 2, Canada
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Montreal Quebec, H2L 4, Canada
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Montreal Quebec, H3A 2, Canada
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Montreal Quebec, H3T 1, Canada
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Trois Rivieres Quebec, G8Z 3, Canada
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Santiago , PISO , Chile
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Guadalajara Jalisco, 44130, Mexico
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Culiacan MEX, 80020, Mexico
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Monterrey Nuevo León, 64710, Mexico
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Distrito Federal , 10700, Mexico
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Guaynabo , 00968, Puerto Rico
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San Juan , 00935, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

3076

Study ID:

NCT01442194

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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