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Safety, Tolerability and Activity Study of Ibudilast in Subjects with Progressive Multiple Sclerosis (NN102/SPRINT-MS)



See All Multiple Sclerosis Trials

The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies.  Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments.  The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.

Description:

This trial will determine the safety, tolerability, and activity of ibudilast in people with primary and secondary-progressive multiple sclerosis (MS).

MS is a chronic, inflammatory demyelinating disease of the central nervous system.  The disease affects 400,000 people in the U.S. and 2 million people worldwide.  Typically MS starts as a relapsing-remitting disorder, with intermittent neurologic episodes called relapses.  Over 10-20 years, the disease transforms gradually into a progressive disorder called secondary progressive MS.  In about 10 percent of cases, individuals with MS have continual disability progression from the very beginning, which is called primary progressive MS.  Despite recent improvements in therapy for the early, relapsing-remitting stage, there are no therapies to slow the progression of either primary or secondary progressive MS.

The SPRINT-MS trial is being conducted by the Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) at 28 U.S. sites.  A total of 250 volunteers, age 21 to 65 years old, will be randomized into 2 groups—one group will receive the study drug, ibudilast, and the other group will receive a placebo, or an inactive substance.  The trial consists of a screening phase (up to 30 days), followed by a treatment phase (96 weeks), and 1 follow-up visit (occurring 1 month after week 96).  The trial will use magnetic resonance imaging (MRI) to assess disease progression and to compare clinical activity.

Duration of the trial for participants is about 2 years.

Eligibility Criteria:

Please follow this link for trial eligibility information to share with your doctor. 

Study Design: 

Interventional

Study Locations: 

Multiple US locations

For more information and more detailed Eligibility Criteria:

Contact:  Dr. Robert Fox, telephone: (216) 445-8597, Email: foxr@ccf.org; or visit http://clinicaltrials.gov/ct2/show/NCT01982942

Last Reviewed July 18, 2014