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: Mar 24, 2022

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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.

Condition 
Multiple Sclerosis
Relapsing Multiple Sclerosis
Advancing Multiple Sclerosis
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Feb 14, 2019
Completion date 
Jul 08, 2022
Gender 
All
Age(s)
18 Years - 65 Years (Adult, Older Adult)

Interventions

Drug
Siponimod
Siponimod 2mg tablets taken once daily

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.
Certain cardiac risk factors defined in the protocol
History of hypersensitivity to the study drug or to drugs of similar chemical classes.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Locations

United States
Novartis Investigative Site
Recruiting
Gilbert, 85297
Arizona
United States
Novartis Investigative Site
Recruiting
Carmichael, 95670
California
United States
Novartis Investigative Site
Recruiting
Tampa, 33609
Florida
United States
Novartis Investigative Site
Recruiting
Louisville, 40207
Kentucky
United States
Novartis Investigative Site
Recruiting
Foxboro, 02035
Massachusetts
United States
Novartis Investigative Site
Recruiting
Clinton Township, 48035
Michigan
United States
Novartis Investigative Site
Recruiting
Audubon, 08106
New Jersey
United States
Novartis Investigative Site
Recruiting
Buffalo, 14202
New York
United States
Novartis Investigative Site
Recruiting
Centerville, 45459
Ohio
United States
Novartis Investigative Site
Recruiting
Cleveland, 44195
Ohio
United States
Novartis Investigative Site
Recruiting
Columbus, 43221
Ohio
United States
Novartis Investigative Site
Recruiting
Toledo, 43623
Ohio
United States
Novartis Investigative Site
Recruiting
Portland, 97225
Oregon
United States
Novartis Investigative Site
Recruiting
Falls Church, 22043
Virginia
United States
Novartis Investigative Site
Recruiting
Milwaukee, 53226
Wisconsin
United States

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals

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Call 1-888-669-6682 or email [email protected]