Browsing by Author "Maragakis, Nicholas"

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    MN-166 (ibudilast) in amyotrophic lateral sclerosis in a Phase IIb/III study: COMBAT-ALS study design
    (Taylor & Francis, 2021) Oskarsson, Björn; Maragakis, Nicholas; Bedlack, Richard S.; Goyal, Namita; Meyer, Jenny A.; Genge, Angela; Bodkin, Cynthia; Maiser, Samuel; Staff, Nathan; Zinman, Lorne; Olney, Nicholas; Turnbull, John; Brooks, Benjamin Rix; Klonowski, Emelia; Makhay, Malath; Yasui, Seiichi; Matsuda, Kazuko; Neurology, School of Medicine
    Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease with motor neuron loss as a defining feature. Despite significant effort, therapeutic breakthroughs have been modest. MN-166 (ibudilast) has demonstrated neuroprotective action by various mechanisms: inhibition of proinflammatory cytokines and macrophage migration inhibitory factor, phosphodiesterase inhibition, and attenuation of glial cell activation in models of ALS. Early-phase studies suggest that MN-166 may improve survival outcomes and slow disease progression in patients with ALS. This article describes the rationale and design of COMBAT-ALS, an ongoing randomized, double-blind, placebo-controlled, multicenter Phase IIb/III study in ALS. This study is designed to evaluate the pharmacokinetics, safety and tolerability and assess the efficacy of MN-166 on function, muscle strength, quality of life and survival in ALS.