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Exploring the Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Patients With Advancing Forms of Relapsing Multiple Sclerosis: A 6-month Open Label, Multi- Center Phase IIIb Study


Brief Summary:

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


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. History of hypersensitivity to the study drug or to drugs of similar chemical classes.

Other protocol-defined inclusion/exclusion criteria may apply.


  • Novartis Investigative Site, Berkeley, California, United States, 94705
  • Novartis Investigative Site, Carmichael, California, United States, 95670
  • Novartis Investigative Site, Fresno, California, United States, 93710
  • Novartis Investigative Site, Fullerton, California, United States, 92835
  • Novartis Investigative Site, Irvine, California, United States, 92617
  • Novartis Investigative Site, Pasadena, California, United States, 91105
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