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 S1P
1 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:
Dr. David Honeycutt
Neurology Associates - MS Center of Greater Orlando
Maitland, FL
407-647-5966 x 204 ,
neurologyassoc@hotmail.com
Dr. Aaron Boster
OhioHealth Research Institute
Columbus, OH
614-566-1250,
aaron.boster@ohiohealth.com
Dr. Samuel Hunter
Advanced Neurosciences Institute
Franklin, TN
615-791-5470,
sfhunter@neurosci.us
Dr. Bennett Machanic
Mountain View Clinical Research, Inc.
Denver, CO
303-388-6461,
b.machanic@mtnviewclinicalresearch.com
Dr. Vernon Rowe
MidAmerica Neuroscience Research Foundation/Rowe Neurology Institute
Lenexa, KS
913-894-1500,
vrowe.research@neurokc.com
Dr. James Scott
Neurology Associates of Ormond Beach - CNS Trials
Ormond Beach, FL
386-676-6340,
neurojscott@yahoo.com
Dr. Ann Bass
Neurology Center of San Antonio
San Antonio, TX
210-490-0016,
annofb@hotmail.com
Dr. Fred Lublin
Mount Sinai School of Medicine - Corinne Goldsmith Dickinson Center for Multiple Sclerosis
New York, NY
212-241-6854,
fred.lublin@mssm.edu
Dr. Stephen Newman
Island Neurological Associates, A Division of Prohealth Care Associates, LLP
Plainview, NY
516-822-2230,
pons46@aol.com
Dr. Thomas Leist
Thomas Jefferson University Hospital - The Comprehensive MS Center
Philadelphia, PA
215-955-6871,
Thomas.Leist@jefferson.edu
Dr. Sharon Lynch
University of Kansas Medical Center
Kansas City, KS
913-588-6980,
slynch@kumc.edu
Dr. Ricardo Ayala
Tallahassee Neurological Clinic
Tallahassee, FL
850-558-1238,
neuroclinic@hotmail.com
Dr. Surisham Dhillon
Care Access Research
Santa Clarita, CA
415-408-2360,
drdhillon@careaccessresearch.com
Dr. Timothy Vollmer
University of Colorado Hospital
Aurora, CO
720-848-2080,
timothy.vollmer@ucdenver.edu
Dr. Khurram Bashir
University of Alabama, Dept. of Neurology
Birmingham, AL
205-996-2092,
kbashir@uabmc.edu
Dr. Ilya Kister
NYU Langone Medical Center - MS Comprehensive Care Center
New York, NY
646-501-7500,
ilya.kister@nyumc.org
Dr. Bijal Mehta
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, CA
310-222-3897,
bmehta@labiomed.org
Dr. Colin Zadikoff
Riverhills Healthcare
Cincinnati, OH
513-241-2370,
czadikoff@riverhillsneuro.com
Dr. Farhan Ahmed Tariq
Hightower Clinical
Oklahoma City, OK
405-534-5349,
tariq@hightowerclinical.com
Dr. Mirela Cerghet
Henry Ford Health System-Neurology
Detroit, MI
313-16-7202,
mcerghe1@hfhs.org
Dr. David Greco
Associated Neurologists
Danbury, CT
203-748-2551,
dgreco@assocneuro.com
Dr. Perminder Bhatia
Neuro-Pain Medical Center
Fresno, CA
559-437-9700,
Bhatia@neuropain.com
Dr. James Shafer
The MS Center of Vero Beach
Vero Beach, FL
772-299-4304,
jshafer@geodysseyrsch.com
Dr. Eric Williamson
Hospital of the University of Pennsylvania
Philadelphia, PA
215-662-3647,
Eric.Williamson@uphs.upenn.edu
Dr. Corey Ford
Univ of New Mexico - Health Sciences Center
Albuquerque, New Mexico
(505)272-0760, msspecialtyclinic@salud.unm.edu
Dr. Surisham Dhillon
Care Access Research
Santa Clarita, CA
415-408-2360, drdhillon@careaccessresearch.com
Dr. Khurram Bashir
UAB Dept. of Neurology
Birmingham, AL
205-934-2402, kbashir@uabmc.edu
Dr. Daniel Kantor
Florida Academic Research, LLC
Boca Raton, FL
561-939-0300, dkantor@floridaacademicresearch.com
Dr. Ahmed Farhan Tariq
Neurology and Neuromuscular Center
Oklahoma City, OK
405-534-5349, tariq@hightowerclinical.com
Dr. David Greco
Associated Neurologists
Danbury, CT
203-748-2551, dgreco@assocneuro.com
Dr. Perminder Bhatia
Neuro-Pain Medical Center
Fresno, CA
559-437-9700, bhatia@neuropain.com
Dr. Orlando Maldonado-Robles
Bradenton Research Center
Bradenton, FL
941-708-0005, om_md@bradentonresearch.com
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