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MS Trial Alert: Investigators Recruiting Worldwide for Phase 3 Trial of Oral Ponesimod Added to Tecfidera®

October 30, 2017

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.
 
DETAILS
Rationale: 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.

Contact: 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:
 
David Honeycutt  
Neurology Associates - MS Center of Greater Orlando
Maitland, FL
407-647-5966 x 204 , neurologyassoc@hotmail.com
 
Aaron Boster        
OhioHealth Research Institute  
Columbus, OH
614-566-1250, aaron.boster@ohiohealth.com
 
Samuel Hunter      
Advanced Neurosciences Institute
Franklin, TN         
615-791-5470, sfhunter@neurosci.us
 
Bennett Machanic 
Mountain View Clinical Research, Inc. 
Denver, CO
303-388-6461, b.machanic@mtnviewclinicalresearch.com
 
Vernon Rowe       
MidAmerica Neuroscience Research Foundation/Rowe Neurology Institute    
Lenexa, KS
913-894-1500, vrowe.research@neurokc.com
 
James Scott 
Neurology Associates of Ormond Beach - CNS Trials       
Ormond Beach, FL
386-676-6340, neurojscott@yahoo.com
 
Ann Bass    
Neurology Center of San Antonio       
San Antonio, TX
210-490-0016, annofb@hotmail.com
 
Fred Lublin 
Mount Sinai School of Medicine - Corinne Goldsmith Dickinson Center for Multiple Sclerosis
New York, NY
212-241-6854, fred.lublin@mssm.edu
 
Stephen Newman 
Island Neurological Associates, A Division of Prohealth Care Associates, LLP 
Plainview, NY
516-822-2230, pons46@aol.com
 
Thomas Leist        
Thomas Jefferson University Hospital - The Comprehensive MS Center
Philadelphia, PA
215-955-6871, Thomas.Leist@jefferson.edu
 
Sharon Lynch       
University of Kansas Medical Center   
Kansas City, KS
913-588-6980, slynch@kumc.edu
 
Ricardo Ayala       
Tallahassee Neurological Clinic  
Tallahassee, FL
850-558-1238, neuroclinic@hotmail.com
 
Surisham Dhillon  
Care Access Research      
Santa Clarita, CA
415-408-2360, drdhillon@careaccessresearch.com
 
Timothy Vollmer  
University of Colorado Hospital
Aurora, CO
720-848-2080, timothy.vollmer@ucdenver.edu
 
Khurram Bashir    
University of Alabama, Dept. of Neurology   
Birmingham, AL
205-996-2092, kbashir@uabmc.edu
 
Ilya Kister   
NYU Langone Medical Center - MS Comprehensive Care Center
New York, NY
646-501-7500, ilya.kister@nyumc.org
 
Bijal Mehta 
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center   
Torrance, CA
310-222-3897, bmehta@labiomed.org
 
Colin Zadikoff
Riverhills Healthcare
Cincinnati, OH
513-241-2370, czadikoff@riverhillsneuro.com
 
Farhan Ahmed Tariq
Hightower Clinical
Oklahoma City, OK
405-534-5349, tariq@hightowerclinical.com
 
Mirela Cerghet
Henry Ford Health System-Neurology
Detroit, MI
313-16-7202, mcerghe1@hfhs.org
 
David Greco
Associated Neurologists
Danbury, CT
203-748-2551, dgreco@assocneuro.com
 
Perminder Bhatia
Neuro-Pain Medical Center
Fresno, CA
559-437-9700, Bhatia@neuropain.com
 
James Shafer
The MS Center of Vero Beach
Vero Beach, FL
772-299-4304, jshafer@geodysseyrsch.com
 
Eric Williamson
Hospital of the University of Pennsylvania
Philadelphia, PA
215-662-3647, Eric.Williamson@uphs.upenn.edu
 
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.
 
Tecfidera® is a registered trademark of Biogen, Inc.
Gilenya® is a registered trademark of Novartis International AG

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.

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