National MS Society Joins with the National Institutes of Health to Fund a Major Trial of a Re-Purposed Therapy in Progressive MS - UPDATED
March 22, 2016
Updated, March 22, 2016: This study has completed enrollment. According to the listing on clinicaltrials.gov, the study should complete data collection by the end of May 2017. Ibudilast was designated by the U.S. Food and Drug Administration as a “Fast Track Product” in terms of its development as a possible treatment of progressive MS.
Investigators at the Cleveland Clinic Foundation are launching a phase II clinical trial of ibudilast (MN-166, MediciNova, Inc.), an oral anti-inflammatory agent, in 250 people with progressive forms of MS. The study is principally funded by NeuroNEXT Network, a clinical trials initiative of the National Institutes of Health, with additional support by MediciNova, the company that will supply ibudilast. The National MS Society actively advocated for this uniquely collaborative trial, and is also providing funding support because it aligns with the Society’s strategic focus on progressive MS, and may answer important questions about the best ways to measure the benefits of therapies aimed at protecting the nervous system from MS. The trial is being conducted at 28 sites across the U.S. under the leadership of Principal Investigator Robert Fox, M.D., M.S., FAAN, Staff Neurologist at the Mellen Center for Multiple Sclerosis at Cleveland Clinic.
“There is a significant, unmet need for treatments that can benefit people with progressive forms of MS,” said Timothy Coetzee, PhD, Chief Research Officer of the National MS Society. “This clinical trial of ibudilast will provide important information on a potential way to stop MS damage, as well as how to measure treatment benefits, and aligns well with the Society’s research agenda for stopping MS progression.” This could lead to shorter, more effective trials and the potential for getting new therapies to people with MS faster.
Background: Ibudilast inhibits an enzyme called phosphodiesterase, resulting in suppression of inflammation. While considered a “New Molecular Entity” in the United States and Europe, ibudilast is marketed in Japan and Korea to treat cerebrovascular disorders and asthma. It is being investigated in the U.S. for its potential to treat drug addiction.
In a previous study, ibudilast did not reduce relapses or MRI-observed new lesions in a phase II trial of 292 people with relapsing MS. However, some evidence that this agent could protect the nervous system from damage (neuroprotection) was observed. Frederick Barkhof, MD, PhD (VU University Medical Center, Amsterdam) and colleagues published these findings in Neurology (2010;74:1033).
This Study: Dr. Fox and his colleagues at Cleveland Clinic is collaborating with co-investigators at 28 academic medical centers in the NeuroNEXT Network. The trial is expected to require approximately three years for enrollment, treatment, and data analyses. The trial is recruiting individuals who have either primary-progressive MS or secondary-progressive MS and who meet specific entrance criteria. Like the Society’s previous investment in a clinical trial of estriol, this trial is an example of how the Society can join with multiple partners to facilitate testing of an “on the shelf” therapy in people with MS.
Read more about progressive MS.