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MS Trial Alert: Investigators Recruiting For Study of Lower Dose of Gilenya Versus Copaxone In MS

July 10, 2013

Summary: Investigators worldwide are recruiting 2,550 people with relapsing-remitting MS to study the safety and effectiveness of a lower dose of Gilenya® capsules (fingolimod, Novartis Pharmaceuticals AG) versus the approved dose as well as the daily standard dose of Copaxone® (glatiramer acetate, Teva Pharmaceutical Industries, Ltd.). The study is funded by Novartis Pharmaceuticals AG.

Rationale: Gilenya was approved by the U.S. Food and Drug Administration (FDA) in 2010 for adults with relapsing forms of MS to reduce the frequency of clinical relapses and to delay the accumulation of physical disability. Gilenya is a new class of medication called a sphingosine 1-phosphate receptor modulator, which is thought to act by retaining certain white blood cells in the lymph nodes, thereby preventing those cells from crossing the blood-brain barrier into the central nervous system. Preventing the entry of these cells reduces inflammatory damage to nerve cells.

Gilenya was approved at a .5 mg dose; this study is testing the effectiveness of a lower dose, .25 mg, versus the approved dose and compared to another approved disease-modifying therapy, Copaxone.

Copaxone is a synthetic protein that simulates myelin basic protein, a component of the myelin that insulates nerve fibers in the brain and spinal cord. It seems to block myelin-damaging T-cells through a mechanism that is not completely understood. Copaxone is approved by the FDA to reduce the frequency of relapses in patients with relapsing-remitting MS and is also approved for use in individuals at high risk for MS.

Eligibility and Details: Participants should be aged 18 through 65, with a diagnosis of relapsing-remitting MS. Further details on inclusion and exclusion criteria are available from the contact below.

Participants will be randomly assigned to take Gilenya capsules daily at either the approved dose (0.5 mg) or at a reduced dose (0.25 mg), or Copaxone (20 mg injected daily under the skin) for 12 months. The primary outcome being measured by this study is the annual relapse rate. Secondary outcomes include drug safety and tolerability, disease activity as observed on MRI scans, brain tissue volume loss and a treatment-satisfaction questionnaire.

Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact  A list of sites is included in the study listing on our Web site. 

Sites are going to be recruiting in the following cities:
  • Akron, OH
  • Albany, NY
  • Alexandria, VA
  • Altoona, PA
  • Amherst, NY
  • Atlanta, GA
  • Aurora, CO
  • Baltimore, MD
  • Bellevue, OH
  • Boston, MA
  • Boulder, CO
  • Buffalo, NY
  • Charlotte, NC
  • Charlottesville, VA
  • Chesterfield, MO
  • Cleveland, OH
  • Clinton Twp, MI
  • Columbus, OH
  • Cullman, AL
  • Dallas, TX
  • Dayton, OH
  • Denver, CO
  • Derby, CT
  • Detroit, MI
  • East Setauket, NY
  • Evanston, IL
  • Fairfield, CT
  • Farmington Hills, M
  • Flossmoor, IL
  • Fort Collins, CO
  • Freehold, NJ
  • Great Falls, MT
  • Guaynabo, PA
  • Hammond, LA
  • Hershey, PA
  • Houston, TX
  • Huntsville, AL
  • Indianapolis, IN
  • Issaquah, WA
  • Jacksonville, FL
  • Kansas City, KS
  • Kansas City, MO
  • Knoxville, TN
  • Las Vegas, NV
  • Lenexa, KS
  • Louisville, KY
  • Loveland, CO
  • Maitland, FL
  • Memphis, TN
  • Nashville, TN
  • New Brunswick, NJ
  • New York, NY
  • Newark, DE
  • Newark, NJ
  • Northbrook, IL
  • Oceanside, CA
  • Oklahoma City, OK
  • Orlando, FL
  • Ormond Beach, FL
  • Patchogue, NY
  • Philadelphia, PA
  • Phoenix, AZ
  • Plainview, NY
  • Pompano Beach, FL
  • Ponte Vedra Beach, FL
  • Providence, RI
  • Quincy, MA
  • Richmond, VA
  • Roanoke, VA
  • Rochester, NY
  • Round Rock, TX
  • Sacramento, CA
  • Saint Louis, MO
  • Salt Lake City, UT
  • San Antonio, TX
  • Sarasota, FL
  • Seattle, WA
  • Sherman, TX
  • Spartanburg, SC
  • Springfield, MA
  • St. Louis, MO
  • Sun City, AZ
  • Syracuse, NY
  • Tallahassee, FL
  • Tampa, FL
  • Teaneck, NJ
  • Toledo, OH
  • Torrance, CA
  • Traverse City, MI
  • Tucson, AZ
  • Tulsa, OK
  • Vero Beach, FL
  • Washington DC
  • West Des Moines, IA
  • West Palm Beach, FL
  • Weston, FL
  • Winston-Salem, NC
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.