Multiple Sclerosis Clinical Trial
Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients
Summary
To assess safety and tolerability of patients converting from approved Relapsing Multiple Sclerosis (RMS) Disease Modifying Therapies (DMTs) to siponimod.
Full Description
This is a 6-month, open-label, multi-center, single arm design, including advancing RMS patients, evaluating the overall safety and tolerability profile of converting from oral, injectable or infusion RMS DMTs to oral siponimod.
Eligibility Criteria
Key Inclusion Criteria:
Signed informed consent.
Male or female aged 18 to 65 years (inclusive).
Patients with advancing RMS as defined by the principal investigator.
Prior history of relapsing MS (RMS), with or without progressive features, according to the 2010 Revised McDonald or Lublin criteria (Lublin et al, 2013).
EDSS score of >/= 2.0 to 6.5 (inclusive).
Having been continuously treated with RMS Disease Modifying Therapies.
Key Exclusion criteria:
Pregnant or nursing (lactating) women.
Patients with any medically unstable condition as determined by the investigator.
Certain cardiac risk factors defined in the protocol
History of hypersensitivity to the study drug or to drugs of similar chemical classes.
Other protocol-defined inclusion/exclusion criteria may apply.
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There are 54 Locations for this study
Birmingham Alabama, 35209, United States
Cullman Alabama, 35058, United States
Homewood Alabama, 35209, United States
Tucson Arizona, 85718, United States
Fresno California, 93710, United States
Fullerton California, 92835, United States
Irvine California, 92617, United States
Colorado Springs Colorado, 80907, United States
Denver Colorado, 80209, United States
Fort Collins Colorado, 80528, United States
Boca Raton Florida, 33487, United States
Bradenton Florida, 34205, United States
Clearwater Florida, 33761, United States
Maitland Florida, 32751, United States
Miami Florida, 33136, United States
Ocala Florida, 34471, United States
Oldsmar Florida, 34677, United States
Orlando Florida, 32806, United States
Ormond Beach Florida, 32174, United States
Sarasota Florida, 34243, United States
Sunrise Florida, 33351, United States
Tampa Florida, 33612, United States
Vero Beach Florida, 32960, United States
Flossmoor Illinois, 60422, United States
Indianapolis Indiana, 46256, United States
Lexington Kentucky, 40503, United States
Lexington Kentucky, 40509, United States
Lexington Kentucky, 40513, United States
Rockville Maryland, 20854, United States
Clinton Township Michigan, 48035, United States
Saint Louis Missouri, 63110, United States
Las Vegas Nevada, 89128, United States
Hackensack New Jersey, 07601, United States
Asheville North Carolina, 28806, United States
Greensboro North Carolina, 27405, United States
Raleigh North Carolina, 27607, United States
Cincinnati Ohio, 45219, United States
Cleveland Ohio, 44106, United States
Oklahoma City Oklahoma, 73104, United States
Abington Pennsylvania, 19001, United States
Philadelphia Pennsylvania, 19141, United States
Willow Grove Pennsylvania, 19090, United States
Greer South Carolina, 29650, United States
Indian Land South Carolina, 29707, United States
Cordova Tennessee, 38018, United States
Johnson City Tennessee, 37604, United States
Round Rock Texas, 78681, United States
San Antonio Texas, 78258, United States
Falls Church Virginia, 22043, United States
Kirkland Washington, 98034, United States
Seattle Washington, 98122, United States
Spokane Washington, 99202, United States
Tacoma Washington, 98405, United States
Waukesha Wisconsin, 53188, United States
Guaynabo , 00968, Puerto Rico
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