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Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients
Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients

NCT03623243

CompletedPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Multiple Sclerosis, Relapsing Multiple Sclerosis, Advancing Multiple Sclerosis

Interventions: Siponimod

Countries: United States, Puerto Rico

To assess safety and tolerability of patients converting from approved Relapsing Multiple Sclerosis (RMS) Disease Modifying Therapies (DMTs) to siponimod.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

1. Signed informed consent.
2. Male or female aged 18 to 65 years (inclusive).
3. Patients with advancing RMS as defined by the principal investigator.
4. Prior history of relapsing MS (RMS), with or without progressive features, according to the 2010 Revised McDonald or Lublin criteria (Lublin et al, 2013).
5. EDSS score of \>/= 2.0 to 6.5 (inclusive).
6. Having been continuously treated with RMS Disease Modifying Therapies.

Key Exclusion criteria:

1. Pregnant or nursing (lactating) women.
2. Patients with any medically unstable condition as determined by the investigator.
3. Certain cardiac risk factors defined in the protocol
4. History of hypersensitivity to the study drug or to drugs of similar chemical classes.

Other protocol-defined inclusion/exclusion criteria may apply.
Locations (55)
  • Birmingham, Alabama, United States
  • Cullman, Alabama, United States
  • Homewood, Alabama, United States
  • Tucson, Arizona, United States
  • Fresno, California, United States
  • Fullerton, California, United States
  • Irvine, California, United States
  • Colorado Springs, Colorado, United States
  • Denver, Colorado, United States
  • Fort Collins, Colorado, United States
  • Boca Raton, Florida, United States
  • Bradenton, Florida, United States
  • Clearwater, Florida, United States
  • Maitland, Florida, United States
  • Miami, Florida, United States
  • Ocala, Florida, United States
  • Oldsmar, Florida, United States
  • Orlando, Florida, United States
  • Ormond Beach, Florida, United States
  • Sarasota, Florida, United States
  • Sunrise, Florida, United States
  • Tampa, Florida, United States
  • Vero Beach, Florida, United States
  • Flossmoor, Illinois, United States
  • Indianapolis, Indiana, United States
  • Lexington, Kentucky, United States
  • Lexington, Kentucky, United States
  • Lexington, Kentucky, United States
  • Rockville, Maryland, United States
  • Clinton Township, Michigan, United States
  • + 25 more on CT.gov