MS Trial Alert: Investigators Recruiting 1,530 People with Secondary-Progressive MS For Study of Sip - National Multiple Sclerosis Society

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MS Trial Alert: Investigators Recruiting 1,530 People with Secondary-Progressive MS For Study of Siponimod

June 26, 2013

Summary: Investigators worldwide are recruiting 1,530 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 clinicaltrials.gov listing at http://clinicaltrials.gov/ct2/show/NCT01665144 .

Sites are going to be recruiting in the following cities; contact information for those that are up and running will be available on the clinicaltrials.gov page:
  • Cullman, Alabama
  • Mobile, Alabama
  • Phoenix, Arizona
  • Scottsdale, Arizona
  • Berkeley, California
  • Los Angeles, California
  • Oceanside, CaliforniaSacramento, 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, an unpredictable, often disabling disease of the central nervous system, interrupts 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 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.

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