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

  • STATUS
    Recruiting
  • End date
    Jan 12, 2022
  • participants needed
    400
  • sponsor
    Novartis Pharmaceuticals
Updated on 20 June 2021
Investigator
Novartis Pharmaceuticals
Primary Contact
Novartis Investigative Site (3.6 mi away) Contact
+68 other location

Summary

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

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.

Details
Condition Multiple Sclerosis, Relapsing MS, Advancing Multiple Sclerosis, Multiple Sclerosis, Relapsing MS, Advancing Multiple Sclerosis, Multiple Sclerosis, Relapsing MS, Advancing Multiple Sclerosis, Multiple Sclerosis, Relapsing MS, Advancing Multiple Sclerosis, Multiple Sclerosis, Relapsing MS, Advancing Multiple Sclerosis, Multiple Sclerosis, Relapsing MS, Advancing Multiple Sclerosis, Multiple Sclerosis, Relapsing MS, Advancing Multiple Sclerosis, Multiple Sclerosis, Relapsing MS, Advancing Multiple Sclerosis, Multiple Sclerosis, Relapsing MS, Advancing Multiple Sclerosis, Multiple Sclerosis, Relapsing MS, Advancing Multiple Sclerosis, Multiple Sclerosis, Relapsing MS, Advancing Multiple Sclerosis, Multiple Sclerosis, Relapsing MS, Advancing Multiple Sclerosis, Multiple Sclerosis, Relapsing MS, Advancing Multiple Sclerosis
Treatment Siponimod
Clinical Study IdentifierNCT03623243
SponsorNovartis Pharmaceuticals
Last Modified on20 June 2021

Eligibility

Yes No Not Sure

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
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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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