Open AccessMN-166 (ibudilast) in amyotrophic lateral sclerosis in a Phase IIb/III study: COMBAT-ALS study design
Author(s) -
Björn Oskarsson,
Nicholas J. Maragakis,
Richard Bedlack,
Namita Goyal,
Jenny A Meyer,
Angela Genge,
Cynthia Bodkin,
Samuel Maiser,
Nathan P. Staff,
Lorne Zinman,
Nicholas Olney,
John Turnbull,
Benjamin Rix Brooks,
Emelia Klonowski,
Malath Makhay,
Seiichi Yasui,
Kazuko Matsuda
Publication year - 2021
Publication title -
neurodegenerative disease management
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.674
H-Index - 23
eISSN - 1758-2032
pISSN - 1758-2024
DOI - 10.2217/nmt-2021-0042
Subject(s) - amyotrophic lateral sclerosis , tolerability , medicine , neuroprotection , riluzole , quality of life (healthcare) , placebo , clinical trial , context (archaeology) , disease , pharmacology , oncology , adverse effect , pathology , paleontology , alternative medicine , nursing , biology
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.