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

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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
Active, not recruiting
Birmingham, 35209
Alabama
United States
Novartis Investigative Site
Completed
Cullman, 35058
Alabama
United States
Novartis Investigative Site
Active, not recruiting
Tucson, 85718
Arizona
United States
Novartis Investigative Site
Active, not recruiting
Berkeley, 94705
California
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
Active, not recruiting
Denver, 80209
Colorado
United States
Novartis Investigative Site
Active, not recruiting
Fort Collins, 80528
Colorado
United States
Novartis Investigative Site
Recruiting
Fairfield, 06824
Connecticut
United States
Novartis Investigative Site
Active, not recruiting
Boca Raton, 33487
Florida
United States
Novartis Investigative Site
Completed
Bradenton, 34205
Florida
United States
Novartis Investigative Site
Active, not recruiting
Maitland, 32751
Florida
United States
Novartis Investigative Site
Recruiting
Miami, 33136
Florida
United States
Novartis Investigative Site
Active, not recruiting
Ocala, 34471
Florida
United States
Novartis Investigative Site
Recruiting
Oldsmar, 34677
Florida
United States
Novartis Investigative Site
Active, not recruiting
Ormond Beach, 32174
Florida
United States
Novartis Investigative Site
Active, not recruiting
Sarasota, 34243
Florida
United States
Novartis Investigative Site
Active, not recruiting
Sunrise, 33351
Florida
United States
Novartis Investigative Site
Recruiting
Tampa, 33609
Florida
United States
Novartis Investigative Site
Active, not recruiting
Tampa, 33612
Florida
United States
Novartis Investigative Site
Active, not recruiting
Flossmoor, 60422
Illinois
United States
Novartis Investigative Site
Recruiting
Northbrook, 60062
Illinois
United States
Novartis Investigative Site
Active, not recruiting
Indianapolis, 46256
Indiana
United States
Novartis Investigative Site
Active, not recruiting
Lenexa, 66214
Kansas
United States
Novartis Investigative Site
Recruiting
Lexington, 40503
Kentucky
United States
Novartis Investigative Site
Active, not recruiting
Lexington, 40509
Kentucky
United States
Novartis Investigative Site
Active, not recruiting
Lexington, 40513
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
Active, not recruiting
Saint Louis, 63110
Missouri
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
Active, not recruiting
Greensboro, 27405
North Carolina
United States
Novartis Investigative Site
Active, not recruiting
Raleigh, 27607
North Carolina
United States
Novartis Investigative Site
Recruiting
Centerville, 45459
Ohio
United States
Novartis Investigative Site
Active, not recruiting
Cincinnati, 45219
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
Active, not recruiting
Willow Grove, 19090
Pennsylvania
United States
Novartis Investigative Site
Active, not recruiting
Greer, 29650
South Carolina
United States
Novartis Investigative Site
Active, not recruiting
Indian Land, 29707
South Carolina
United States
Novartis Investigative Site
Active, not recruiting
Cordova, 38018
Tennessee
United States
Novartis Investigative Site
Active, not recruiting
Johnson City, 37604
Tennessee
United States
Novartis Investigative Site
Recruiting
Knoxville, 37922
Tennessee
United States
Novartis Investigative Site
Completed
Round Rock, 78681
Texas
United States
Novartis Investigative Site
Recruiting
San Antonio, 78258
Texas
United States
Novartis Investigative Site
Active, not recruiting
Falls Church, 22043
Virginia
United States
Novartis Investigative Site
Active, not recruiting
Newport News, 23601
Virginia
United States
Novartis Investigative Site
Active, not recruiting
Kirkland, 98034
Washington
United States
Novartis Investigative Site
Active, not recruiting
Seattle, 98122
Washington
United States
Novartis Investigative Site
Active, not recruiting
Spokane, 99202
Washington
United States
Novartis Investigative Site
Completed
Tacoma, 98405
Washington
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
Puerto Rico
Novartis Investigative Site
Active, not recruiting
Guaynabo, 00968
-
Puerto Rico

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]