MS Trial Alert: Investigators Recruiting 250 People with Primary- or Secondary-Progressive MS for St - National Multiple Sclerosis Society

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MS Trial Alert: Investigators Recruiting 250 People with Primary- or Secondary-Progressive MS for Study of Oral Ibudilast – UPDATED with contact information for 28 sites

June 11, 2014

Summary: Investigators are recruiting for a phase II clinical trial of ibudilast (MN-166, MediciNova, Inc.), an oral agent, in 250 people with progressive forms of MS, at 28 sites nationwide. The study, called the SPRINT-MS trial, is principally funded by the National Institutes of Neurological Diseases and Stroke (NINDS), with additional support by MediciNova, the company that will supply ibudilast, and the National MS Society. The study will be conducted through the NeuroNEXT Network, a clinical trials initiative of the National Institutes of Health. Robert Fox, MD (Cleveland Clinic Foundation) is the principal investigator.

Rationale: Among other actions, ibudilast inhibits an enzyme called phosphodiesterase, and has been shown to protect brain tissue in animal models. . While considered a “New Chemical Entity” in the United States and Europe, ibudilast is marketed in Japan and Korea to treat asthma and symptoms from cerebrovascular disorders. It is being investigated in the U.S. for its potential to treat drug addiction and now, for treating progressive forms of MS. In a previous study, ibudilast did not reduce relapses or MRI-observed new lesions in a phase II trial involving people with relapsing MS. However, some evidence that this agent could protect the nervous system from damage (neuroprotection) was observed, which is why it’s being tested in people with progressive forms of MS. (Neurology 2010;74:1033).

Eligibility and Details: Participants are people between the ages of 21 and 65 who are diagnosed with secondary-progressive or primary-progressive MS who are currently receiving either glatiramer acetate, interferon beta, or neither treatment. . Further details on inclusion and exclusion criteria are available from the contact below.

Participants will be randomly assigned to receive either oral ibudilast (100 mg/day) or inactive placebo daily for 96 weeks. Treatment will be added to existing glatiramer or interferon treatment in patients currently taking those therapies. The primary outcomes being measured are changes in brain tissue volume loss (determined through MRI scans) and safety/tolerability. Secondary outcomes being measured include further imaging outcomes, progression as measured by the EDSS disability scale, quality of life, cognitive function, and pain.

Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact the study site nearest you. The following 28 sites nationwide are enrolling participants:

The following 28 sites nationwide are enrolling participants:



University of Alabama at Birmingham, Birmingham, Alabama

Contact: Beverly Layton    205-934-1885    



University of California Davis, Davis, California

Contact: Janelle Butters, RN    916-734-6276    

Contact: Randev Sandhu, CCRP    


University of California Los Angeles, Los Angeles, California

Contact: Catherine Canamar    

Contact: Jenny Bardens    



University of Colorado Denver, Denver, Colorado

Contact: Kathryn Connelly    303-724-5128    

Contact: AJ Stein    303-724-6346    



University of Miami Miller School of Medicine, Miami, Florida

Contact: Gloria Rodriguez    305-243-8052    



Emory University, Atlanta, Georgia

Contact: Kanoa Folami    404-778-3444     



Northwestern University, Evanston, Illinois

Contact: Pat Casey, MS    312-695-0774    

Contact: Linda Reisberg    312-695-0083    



University of Kansas Medical Center, Kansas City, Kansas

Contact: Lisa Schmidt, LPN    913-588-3968    



Brigham and Women's Hospital, Boston, Massachusetts

Contact: Sandra Cook, RN    617-525-6585    


Massachusetts General Hospital, Boston, Massachusetts

Contact: Anne Bozik    



Washington University School of Medicine in St Louis, St Louis, Missouri

Contact: Mengesha Teshome    

Contact: Susan Fox    314-362-2017    


New York

Montefiore Medical Center, Bronx, New York

Contact: Donna Patch, RN    718-920-6690    


University at Buffalo, The State University of New York, Buffalo, New York

Contact: Kara Patrick    716-859-7510    

Contact: Karen Zakalik    


Cornell Medical College, New York City, New York

Contact: Bill Nikolov    212-746-9882    


Columbia University Medical Center, New York City, New York

Contact: Deborah E Gohs    


University of Rochester, Rochester, New York

Contact: Eileen Scheid    585-275-6673    


University at Stony Brook, The State University of New York, Stony Brook, New York

Contact: Traci Bower    


University at Upstate, The State University of New York, Syracuse, New York

Contact: Andrea McGlond    315-464-5302    



University of Cincinnati, Department of Neurology, Cincinnati, Ohio

Contact: Kim Moeller    


Cleveland Clinic, Cleveland, Ohio

Contact: John Mays    216-445-6339    


Ohio State University, Columbus, Ohio

Contact: Misty Cost    

Contact: Jessica DeJesus    614-366-3757    



Oregon Health and Science University, Portland, Oregon

Contact: Debbie Griffith    503-494-5759    



University of Pittsburgh, Pittsburgh, Pennsylvania

Contact: Kerry Oddis    412-692-4918    



Vanderbilt University, Nashville, Tennessee

Contact: Jennifer Scott, RN    615-322-4085    



University of Texas Southwestern Medical Center, Dallas, Texas

Contact: Sam Hughes     



University of Utah, Salt Lake City, Utah

Contact: Tammy Floore, RN    801-585-5227    

Contact: Sara Woltz    



University of Virginia Charlottesville, Charlottesville, Virginia

Contact: Margaret Keller, RN    



Swedish Medical Center - Seattle         , Seattle, Washington

Contact: Becky Wood    

Contact: Beena Gangadharan    


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.