CompletedPhase 3

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

United States185 participantsStarted 2019-02-14

Plain-language summary

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

Who can participate

Age range18 Years – 65 Years

SexALL

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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.

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.

What they're measuring

Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) Related to Study Drug During the Treatment Period

Timeframe: From first dose of study drug up to 30 days after last dose of study drug (up to 7 months)

Trial details

NCT IDNCT03623243

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-07-06

Results submitted2023-06-28

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