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MS Trial Alert: Investigators Recruiting 1530 People with Secondary-Progressive MS For Study of Siponimod

June 27, 2013

Summary: Investigators worldwide are recruiting 1530 people with secondary-progressive MS for a phase 3 study testing the safety and effectiveness of the experimental oral therapy siponimod (BAF312, Novartis Pharmaceuticals AG) versus inactive placebo. The study is funded by Novartis Pharmaceuticals AG.

Rationale: Siponimod is an experimental immune system-modulating therapy that was designed to be a more selective sphingosine 1-phosphate receptor modulator than Gilenya™ (fingolimod, Novartis International AG), which was approved in 2010 for adults with relapsing forms of MS to reduce the frequency of clinical relapses and to delay the accumulation of physical disability. Siponimod (BAF312) is a selective sphingosine 1-phosphate receptor1,5 modulator. Siponimod previously demonstrated safety and efficacy on MRI scans in a phase 2 study in people with relapsing-remitting MS (The Lancet Neurology, Early Online Publication, June 11, 2013).  Siponimod is thought to act by retaining certain white blood cells in the body’s lymph nodes, keeping them out of circulation and from entering the central nervous system. Siponimod also distributes effectively to the central nervous system where it may have direct anti-inflammatory or neurobioloical effects.

Eligibility and Details: Participants should be aged 18 through 60, with a diagnosis of secondary-progressive MS. Participants cannot have had a recent relapse treated with corticosteroids. Further details on inclusion and exclusion criteria are available from the contact below.

Participants will be randomly assigned to take siponimod (1050 participants) or placebo (510 participants) capsules daily for up to 60 months. The primary outcome being measured by this study is the delay in time to confirmed disability progression as measured by the EDSS scale. Secondary outcomes include disease activity as observed on MRI scans, scales measuring mobility, relapse rates, adverse events, and abnormalities on lab tests.

Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please call 1-888-669-6682 or visit the study’s listing.  

Sites are going to be recruiting in the following cities; contact information for those that are up and running will be available on the page:
Cullman, Alabama
Mobile, Alabama
Phoenix, Arizona
Scottsdale, Arizona
Berkeley, California
Los Angeles, California
Oceanside, California
Sacramento, California
San Francisco, California 
Stanford, California 
Torrance, California 
Aurora, Colorado 
Boulder, Colorado 
Centennial, Colorado 
Englewood, Colorado 
Fort Collins, Colorado 
Danbury, Connecticut 
Fairfield, Connecticut 
North Haven, Connecticut 
Newark, Delaware 
Washington, District of Columbia 
Fort Lauderdale, Florida 
Jacksonville, Florida 
Miami, Florida 
Ormond Beach, Florida 
Pensacola, Florida 
St. Petersburg, Florida 
Sunrise, Florida 
Tallahassee, Florida 
Tampa, Florida 
Vero Beach, Florida 
West Palm Beach, Florida
Weston, Florida 
Chicago, Illinois
Evanston, Illinois 
Flossmoor, Illinois
Palos Heights, Illinois 
Lenexa, Kansas 
Louisville, Kentucky 
Baltimore, Maryland 
Boston, Massachusetts 
Lexington, Massachusetts 
Worcester, Massachusetts 
Ann Arbor, Michigan 
Detroit, Michigan 
Farmington Hills, Michigan  
Grand Rapids, Michigan 
Golden Valley, Minnesota 
Minneapolis, Minnesota 
Las Vegas, Nevada 
Lebanon, New Hampshire 
Teaneck, New Jersey 
Toms River, New Jersey 
Voorhees, New Jersey 
Albuquerque, New Mexico
Albany, New York 
Amherst, New York
Bronx, New York 
Latham, New York
Mineola, New York
New York, New York
Patchogue, New York
Plainview, New York
Rochester, New York
Stony Brook, New York
Syracuse, New York 
Charlotte, North Carolina
Durham, North Carolina
Akron, Ohio
Bellevue, Ohio
Cleveland, Ohio
Dayton, Ohio
Toledo, Ohio
Oklahoma City, Oklahoma
Portland, Oregon
Philadelphia, Pennsylvania
Providence, Rhode Island
Bristol, Tennessee 
Cordova, Tennessee
Nashville, Tennessee
Dallas, Texas
Lubbock, Texas
Round Rock, Texas
San Antonio, Texas
Burlington, Vermont
Alexandria, Virginia 
Seattle, Washington
Green Bay, Wisconsin
Madison, Wisconsin
Milwaukee, Wisconsin
Waukesha, Wisconsin

Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.