NeuroNEXT is pleased to announce funding for our next approved trial: SPRINT-MS: "A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Activity of Ibudilast (MN-166) in Subjects with Progressive Multiple Sclerosis"
Robert J. Fox, MD, MS, FAAN, Cleveland Clinic, is the Protocol Principal Investigator for the study “A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Activity of Ibudilast (MN-166) in Subjects with Progressive Multiple Sclerosis,” which is also called SPRINT-MS.
Multiple Sclerosis (MS) is a chronic, inflammatory demyelinating disease of the central nervous system that affects 400,000 people in the US and 2 million people worldwide. Those affected with the disease are characterized into one of three variants: relapsing-remitting, secondary progressive and primary progressive. Despite recent improvements in pharmacotherapy for relapsing remitting multiple sclerosis, there are no therapies with demonstrated efficacy in either secondary progressive or primary progressive multiple sclerosis in the absence of relapses.
This research study is being conducted to determine the safety, tolerability and activity of ibudilast (MN-166) administered twice daily over a 96 week period in subjects with primary and secondary progressive multiple sclerosis. The study will be conducted by the NIH-funded NeuroNEXT Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) in NeuroNEXT sites around the United States. A total of 250 male and female subjects from 21 to 65 years old, inclusive, are planned to be enrolled into 2 treatment arms (ibudilast or matching-placebo). Subjects may be on injectable immunomodulating therapies (interferon-beta or glatiramer acetate) or on no immunomodulating therapies. The trial will utilize advanced brain imaging to assess disease progression and correlate clinical activity with these imaging measures.
This study is also being supported by MediciNova, the pharmaceutical company that is developing ibudilast, and the National Multiple Sclerosis Society as part of a private-public partnership with the NIH.