Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients.
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
ClinicalTrials.gov Identifier: NCT03623243
Novartis Reference Number: CBAF312AUS02
Last Update: Aug 07, 2020
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
Study Description
To assess safety and tolerability of patients converting from approved Relapsing Multiple Sclerosis (RMS) Disease Modifying Therapies (DMTs) to siponimod.
Interventions
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.
History of hypersensitivity to the study drug or to drugs of similar chemical classes.
Other protocol-defined inclusion/exclusion criteria may apply.
Study Locations
Contacts
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