MN-166 (ibudilast) in amyotrophic lateral sclerosis in a Phase IIb/III study: COMBAT-ALS study design

Björn Oskarsson, Nicholas Maragakis, Richard S. Bedlack, Namita Goyal, Jenny A. Meyer, Angela Genge, Cynthia Bodkin, Samuel Maiser, Nathan Staff, Lorne Zinman, Nicholas Olney, John Turnbull, Benjamin Rix Brooks, Emelia Klonowski, Malath Makhay, Seiichi Yasui, Kazuko Matsuda

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish (US)
Pages (from-to)431-443
Number of pages13
JournalNeurodegenerative disease management
Issue number6
StatePublished - Dec 2021


  • ALS
  • amyotrophic lateral sclerosis
  • glial cell attenuation
  • ibudilast
  • neurodegenerative disease
  • neuroprotection
  • survival

ASJC Scopus subject areas

  • Clinical Neurology


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