The second study and first clinical trial conducted by the Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) will focus on Progressive MS.
NeuroNEXT Network Progressive Multiple Sclerosis Clinical Trial
We are pleased to announce the funding of the second study and first clinical trial conducted by the Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), supported by the National Institute of Neurological Disorders and Stroke (NINDS). 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.
Built upon the infrastructure of the MGH Neurological Clinical Research Institute (NCRI), the Clinical Coordinating Center (CCC) for NeuroNEXT is directed by Merit Cudkowicz, MD, chief of Neurology. The primary goal of the CCC is to facilitate, from initial conception through final analysis, high-impact Phase II clinical trials in adult and pediatric neurological disorders by providing efficient methodological, organizational and logistical support. Utilizing its performance-improvement expertise, the CCC will provide training and tools designed to help research sites decrease start-up time, increase recruitment and retention, and improve data quality and validity throughout the course of the trial.
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. 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 injectableimmunomodulating therapies (interferon-beta or glatiramer acetate) or on no immunomodulating therapies. The trial will utilize advanced brain imaging to assess activity 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 (NMSS) as part of a private-public partnership with the NIH.
The following sites have been invited to enroll subjects in the study:
• Massachusetts General Hospital
• Brigham and Women’s Hospital
• University of Alabama
• University of Cincinnati
• University of Pittsburgh
• Cleveland Clinic
• Albert Einstein College of Medicine
• University of Kansas
• University of Miami
• University of Rochester
• Swedish Neuroscience Institute
• University of Virginia
• Columbia University Medical Center
• Weill Cornell Medical College
• State University of New York at Stony Brook
• State University of New York at Buffalo
• State University of New York Upstate Medical University
• Northwestern University
• Ohio State University
• Washington University in St. Louis School of Medicine
• Emory University
• University of Texas Southwestern Medical Center
• Vanderbilt University
• University of California – Davis
• University of California – Los Angeles
• University of Colorado – Denver
• University of Utah
• Oregon Health and Science University