SUMMARY: Investigators are recruiting 600 people with relapsing MS for a clinical trial examining the effectiveness of adding ponesimod, an oral compound that affects immune function, in people who are still experiencing relapses while taking Tecfidera®
(dimethyl fumarate, Biogen, Inc.). The study sponsor is Actelion, a Janssen Pharmaceutical Company of Johnson & Johnson.
: Multiple sclerosis involves an immune system attack on the brain and spinal cord. Ponesimod is a compound that binds to a docking site (sphingosine-1-phosphate receptor 1, or S1P1
receptor) on immune cells, including T cells and B cells (lymphocytes) that have been implicated in causing nervous system damage in MS. The once-a-day pill induces immune cells to remain in lymph nodes, inhibiting their migration into the brain and spinal cord. A similar therapy, Gilenya®
(fingolimod, Novartis International AG) is approved by the U.S. FDA to treat relapsing MS. This trial asks the question of whether ponesimod, added to Tecfidera therapy, can reduce the incidence of MS relapses. In an earlier phase II study in people with MS, all three tested doses of ponesimod significantly reduced disease activity seen on MRI scans (Journal of Neurology, Neurosurgery and Psychiatry 2014 Nov; 85(11): 1198–1208
). A phase 3 study of ponesimod versus teriflunomide is ongoing, but has completed its recruitment.
Eligibility and Details
: Participants may include adult males and females aged 18 to 55 with a diagnosis of relapsing MS (including people with relapsing-remitting MS, and those with secondary-progressive MS experiencing relapses). Participants are required to have been taking Tecfidera for 6 months before enrolling in the study. Participants must also have experienced a relapse or
have current disease activity on an MRI scan of the brain or spinal cord within 12 months prior to screening and after at least 3 months of Tecfidera treatment. Additional criteria – including previous treatment or medical conditions that might exclude individuals from participating – can be obtained by contacting the study investigators listed below.
Participants will be randomly assigned to receive oral ponesimod once daily or inactive placebo once daily, in addition to ongoing Tecfidera treatment, for a minimum of 60 weeks (for the last subject enrolled) up to a maximum of 156 weeks. The primary outcome being measured is the rate of relapses. Other outcomes being measured include disability progression, effect on brain tissue volume, time to first relapse, disease activity observed on MRI scans, fatigue, and adverse events.
: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact the site nearest you:
Neurology Associates - MS Center of Greater Orlando
407-647-5966 x 204 , email@example.com
OhioHealth Research Institute
Advanced Neurosciences Institute
Mountain View Clinical Research, Inc.
MidAmerica Neuroscience Research Foundation/Rowe Neurology Institute
Neurology Associates of Ormond Beach - CNS Trials
Ormond Beach, FL
Neurology Center of San Antonio
San Antonio, TX
Mount Sinai School of Medicine - Corinne Goldsmith Dickinson Center for Multiple Sclerosis
New York, NY
Island Neurological Associates, A Division of Prohealth Care Associates, LLP
Thomas Jefferson University Hospital - The Comprehensive MS Center
University of Kansas Medical Center
Kansas City, KS
Tallahassee Neurological Clinic
Care Access Research
Santa Clarita, CA
University of Colorado Hospital
University of Alabama, Dept. of Neurology
NYU Langone Medical Center - MS Comprehensive Care Center
New York, NY
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Farhan Ahmed Tariq
Oklahoma City, OK
Henry Ford Health System-Neurology
Neuro-Pain Medical Center
The MS Center of Vero Beach
Vero Beach, FL
Hospital of the University of Pennsylvania
Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).
Without participants in research studies, MS research would come to a standstill. Read more here
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