MN-166 (ibudilast) in amyotrophic lateral sclerosis in a Phase IIb/III study: COMBAT-ALS study design-Reference-Cited by-同舟云学术

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

Published:2021-12 Issue:6 Volume:11 Page:431-443
ISSN:1758-2024
Container-title:Neurodegenerative Disease Management
language:en
Short-container-title:Neurodegenerative Disease Management

Author:

Oskarsson Björn¹^ORCID,Maragakis Nicholas²^ORCID,Bedlack Richard S³^ORCID,Goyal Namita⁴^ORCID,Meyer Jenny A⁵,Genge Angela⁶^ORCID,Bodkin Cynthia⁷,Maiser Samuel⁸,Staff Nathan⁹^ORCID,Zinman Lorne¹⁰^ORCID,Olney Nicholas¹¹^ORCID,Turnbull John¹²,Brooks Benjamin Rix¹³^ORCID,Klonowski Emelia¹⁴,Makhay Malath¹⁴,Yasui Seiichi¹⁵^ORCID,Matsuda Kazuko¹⁴

Affiliation:

1. Department of Neurology, Mayo Clinic, Jacksonville, FL, USA

2. Department of Neurology, John Hopkins University, Baltimore, MD, USA

3. Department of Neurology Duke University, Durham, NC, USA

4. Department of Neurology, University California Irvine, Irvine, CA, USA

5. Department of Neurology, SUNY Upstate Medical University, Syracuse, NY, USA

6. Montreal Neurological Institute, Montreal, Quebec, Canada

7. Department of Neurology, University of Indiana, Indianapolis, IN, USA

8. Department of Neurology, Hennepin County Hospital, Minneapolis, MN, USA

9. Department of Neurology, Mayo Clinic, Rochester, MN, USA

10. Department of Neurology, Sunnybrook Health Sciences Centre, Toronto, ON, Canada

11. Providence Health, Portland, OR, USA

12. Department of Medicine, McMaster University, Hamilton, ON, Canada

13. Clinical Trials Planning LLC, NC, USA

14. MediciNova, San Diego, CA, USA

15. Faculty of Science and Technology, Department of Industrial Administration, University of Tokyo, Japan

Abstract

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.

Funder

Medicinova

Publisher

Future Medicine Ltd

Subject

Neurology (clinical)

Link

https://www.futuremedicine.com/doi/pdf/10.2217/nmt-2021-0042

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