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:

 

Alabama

University of Alabama at Birmingham, Birmingham, Alabama

Contact: Beverly Layton    205-934-1885    blayton@uab.edu    

 

California

University of California Davis, Davis, California

Contact: Janelle Butters, RN    916-734-6276    Janelle.butters@ucdmc.ucdavis.edu    

Contact: Randev Sandhu, CCRP       rssandhu@ucdavis.edu    

 

University of California Los Angeles, Los Angeles, California

Contact: Catherine Canamar       CCanamar@mednet.ucla.edu    

Contact: Jenny Bardens       JBardens@mednet.ucla.edu    

 

Colorado

University of Colorado Denver, Denver, Colorado

Contact: Kathryn Connelly    303-724-5128    kathryn.connelly@ucdenver.edu    

Contact: AJ Stein    303-724-6346    alexander.stein@ucdenver.edu    

 

Florida

University of Miami Miller School of Medicine, Miami, Florida

Contact: Gloria Rodriguez    305-243-8052    GRodriguez13@med.miami.edu    

 

Georgia

Emory University, Atlanta, Georgia

Contact: Kanoa Folami    404-778-3444    kfolami@emory.edu     

 

Illinois

Northwestern University, Evanston, Illinois

Contact: Pat Casey, MS    312-695-0774    Pcasey1@nmff.org    

Contact: Linda Reisberg    312-695-0083    l-reisberg@northwestern.edu    

 

Kansas

University of Kansas Medical Center, Kansas City, Kansas

Contact: Lisa Schmidt, LPN    913-588-3968    lschmidt@kumc.edu    

   

Massachusetts

Brigham and Women's Hospital, Boston, Massachusetts

Contact: Sandra Cook, RN    617-525-6585    scook@partners.org    

 

Massachusetts General Hospital, Boston, Massachusetts

Contact: Anne Bozik       abozik@partners.org    

 

Missouri

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

Contact: Mengesha Teshome       teshomem@neuro.wustl.edu    

Contact: Susan Fox    314-362-2017    foxs@neuro.wustl.edu    

 

New York

Montefiore Medical Center, Bronx, New York

Contact: Donna Patch, RN    718-920-6690    donna.patch@einstein.yu.edu    

 

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

Contact: Kara Patrick    716-859-7510    Kpatrick@buffalo.edu    

Contact: Karen Zakalik       kzakalik@buffalo.com    

 

Cornell Medical College, New York City, New York

Contact: Bill Nikolov    212-746-9882    Bln2001@med.cornell.edu    

 

Columbia University Medical Center, New York City, New York

Contact: Deborah E Gohs       deg15@columbia.edu    

 

University of Rochester, Rochester, New York

Contact: Eileen Scheid    585-275-6673    Eileen_scheid@urmc.rochester.edu    

 

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

Contact: Traci Bower       Traci.Bower@stoneybrookmedicine.edu    

 

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

Contact: Andrea McGlond    315-464-5302    mcglonda@upstate.edu    

 

Ohio

University of Cincinnati, Department of Neurology, Cincinnati, Ohio

Contact: Kim Moeller       moelleky@ucmail.uc.edu    

 

Cleveland Clinic, Cleveland, Ohio

Contact: John Mays    216-445-6339    maysj1@ccf.org    

 

Ohio State University, Columbus, Ohio

Contact: Misty Cost       misty.cost@osumc.edu    

Contact: Jessica DeJesus    614-366-3757    Jessica.DeJesus@osumc.edu    

 

Oregon

Oregon Health and Science University, Portland, Oregon

Contact: Debbie Griffith    503-494-5759    griffide@ohsu.edu    

 

Pennsylvania

University of Pittsburgh, Pittsburgh, Pennsylvania

Contact: Kerry Oddis    412-692-4918    kmoddis@upmc.edu    

 

Tennessee

Vanderbilt University, Nashville, Tennessee

Contact: Jennifer Scott, RN    615-322-4085    Jennifer.I.scott@vanderbilt.edu    

 

Texas

University of Texas Southwestern Medical Center, Dallas, Texas

Contact: Sam Hughes       samuel.hughes@utsouthwestern.edu     

 

Utah

University of Utah, Salt Lake City, Utah

Contact: Tammy Floore, RN    801-585-5227    Tammy.floore@hsc.utah.edu    

Contact: Sara Woltz       sara.woltz@hsc.utah.edu    

 

Virginia

University of Virginia Charlottesville, Charlottesville, Virginia

Contact: Margaret Keller, RN       mfk8e@virginia.edu    

 

Washington

Swedish Medical Center - Seattle         , Seattle, Washington

Contact: Becky Wood       Becky.Wood@swedish.org    

Contact: Beena Gangadharan       benna.gangadharan@swedish.org    

 

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.

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