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

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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 MS, Advancing Multiple Sclerosis
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
400 participants
Start date 
Feb 14, 2019
Completion date 
Jan 11, 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.
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
Carmichael, 95670
California
United States
Novartis Investigative Site
Recruiting
Fresno, 93710
California
United States
Novartis Investigative Site
Recruiting
Fullerton, 92835
California
United States
Novartis Investigative Site
Recruiting
Irvine, 92617
California
United States
Novartis Investigative Site
Recruiting
Pasadena, 91105
California
United States
Novartis Investigative Site
Recruiting
Colorado Springs, 80907
Colorado
United States
Novartis Investigative Site
Recruiting
Fairfield, 06824
Connecticut
United States
Novartis Investigative Site
Recruiting
Miami, 33136
Florida
United States
Novartis Investigative Site
Recruiting
Oldsmar, 34677
Florida
United States
Novartis Investigative Site
Recruiting
Tampa, 33609
Florida
United States
Novartis Investigative Site
Recruiting
Northbrook, 60062
Illinois
United States
Novartis Investigative Site
Recruiting
Lexington, 40503
Kentucky
United States
Novartis Investigative Site
Recruiting
Louisville, 40207
Kentucky
United States
Novartis Investigative Site
Recruiting
Foxboro, 02035
Massachusetts
United States
Novartis Investigative Site
Recruiting
Wellesley, 02481
Massachusetts
United States
Novartis Investigative Site
Recruiting
Las Vegas, 89128
Nevada
United States
Novartis Investigative Site
Recruiting
Audubon, 08106
New Jersey
United States
Novartis Investigative Site
Recruiting
Hackensack, 07601
New Jersey
United States
Novartis Investigative Site
Recruiting
Buffalo, 14202
New York
United States
Novartis Investigative Site
Recruiting
Asheville, 28806
North Carolina
United States
Novartis Investigative Site
Recruiting
Centerville, 45459
Ohio
United States
Novartis Investigative Site
Recruiting
Cleveland, 44106-5028
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
Westerville, 43081
Ohio
United States
Novartis Investigative Site
Recruiting
Oklahoma City, 73104
Oklahoma
United States
Novartis Investigative Site
Recruiting
Portland, 97225
Oregon
United States
Novartis Investigative Site
Recruiting
Philadelphia, 19141
Pennsylvania
United States
Novartis Investigative Site
Recruiting
Knoxville, 37922
Tennessee
United States
Novartis Investigative Site
Recruiting
San Antonio, 78258
Texas
United States
Novartis Investigative Site
Recruiting
Green Bay, 54311
Wisconsin
United States
Novartis Investigative Site
Recruiting
Milwaukee, 53226
Wisconsin
United States
Novartis Investigative Site
Recruiting
Neenah, 54956
Wisconsin
United States
Novartis Investigative Site
Recruiting
Waukesha, 53188
Wisconsin
United States

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals

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