Adverse events with ibudilast included gastrointestinal symptoms, headache, and depression. The rate of change in the brain parenchymal fraction was -0.0010 per year with ibudilast and -0.0019 per year with placebo (difference, 0.0009 95% confidence interval, 0.00004 to 0.0017 P=0.04), which represents approximately 2.5 ml less brain-tissue loss with ibudilast over a period of 96 weeks. A total of 53% of the patients in the ibudilast group and 52% of those in the placebo group had primary progressive disease the others had secondary progressive disease. Of 255 patients who underwent randomization, 129 were assigned to ibudilast and 126 to placebo. Major secondary end points included the change in the pyramidal tracts on diffusion tensor imaging, the magnetization transfer ratio in normal-appearing brain tissue, the thickness of the retinal nerve-fiber layer, and cortical atrophy, all measures of tissue damage in multiple sclerosis. The primary efficacy end point was the rate of brain atrophy, as measured by the brain parenchymal fraction (brain size relative to the volume of the outer surface contour of the brain).
#SWEET CINDY MDG TRIAL#
We enrolled patients with primary or secondary progressive multiple sclerosis in a phase 2 randomized trial of oral ibudilast (≤100 mg daily) or placebo for 96 weeks.
Ibudilast inhibits several cyclic nucleotide phosphodiesterases, macrophage migration inhibitory factor, and toll-like receptor 4 and can cross the blood-brain barrier, with potential salutary effects in progressive multiple sclerosis. There are limited treatments for progressive multiple sclerosis. Narayanan) the School of Health Sciences, College of Health and Human Sciences, Purdue University, West Lafayette, IN (X.Z.) University of Colorado Denver, Aurora (E.A.) University of Alabama at Birmingham, Birmingham (K.B.) Feinberg School of Medicine, Northwestern University, Chicago (B.A.C.) University of Miami Miller School of Medicine, Miami (S.D.) University of Utah, Salt Lake City (L.D.D.) University of Texas Southwestern Medical Center, Dallas (A.F.) University of Virginia at Charlottesville, Charlottesville (M.D.G.) Emory University, Atlanta (N.L.) University of Kansas Medical Center, Kansas City (S.G.L.) Vanderbilt University, Nashville (H.M.) University of Pittsburgh Medical Center, Pittsburgh (V.S.) and Oregon Health and Science University, Portland (V.Y.). Joseph's Hospital and Medical Center, Phoenix, AZ (J.P.D.) NeuroRx Research, Montreal (S. Louis (R.T.N.) Barrow Neurological Institute, St. Thornell), the Department of Neurology, Massachusetts General Hospital, Harvard Medical School (E.C.K.), and Brigham and Women's Hospital (C.S.), Boston patient advocate (T.G.) and Swedish Medical Center at Seattle (P.R.), Seattle University of Rochester Medical Center, Rochester (A.G.), Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Mount Sinai Medical Center (S.K.), Weill Cornell Medical College (J.S.P.), Columbia University Medical Center (C.S.R.), and Montefiore Medical Center, Albert Einstein College of Medicine (S.S.), New York, State University of New York (SUNY) at Stony Brook, Stony Brook (P.K.C.), SUNY Upstate Medical University, Syracuse (B.J.), and SUNY at Buffalo, Buffalo (B.W.-G.) - all in New York MediciNova, La Jolla (K.M.), University of California at Davis, Sacramento (M.A.), and University of California at Los Angeles, Los Angeles (B.S.G.) - all in California Washington University School of Medicine, St. Thoomukuntla), Cleveland Clinic, Cleveland, Ohio State University, Columbus (M.R.), and University of Cincinnati, Cincinnati (A.Z.) - all in Ohio the Data Coordinating Center, Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT), University of Iowa, Iowa City (C.S.C., J.B., D.E., E.K., M.K., J.D.L., J.Y.) the National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.) the Clinical Coordinating Center, NeuroNEXT, Massachusetts General Hospital, Neurological Clinical Research Institute, Harvard Partners (M.E.C., M.M., A.A., B. Natarajan, R.A.B., D.O.), the Imaging Institute (X.H., M.J.L., K.E.S., X.Z.), and the Department of Biomedical Engineering (P.J., K.N., B.
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