Phase 3b Extension Study <scp>MT</scp> ‐1186‐ <scp>A04</scp> to Evaluate the Continued Efficacy and Safety of Edaravone Oral Suspension for Up to an Additional 48 Weeks in Patients With Amyotrophic Lateral Sclerosis
Similar to Study MT-1186-A02, once daily edaravone oral suspension in extension Study MT-1186-A04 did not show superiority in terms of the primary efficacy endpoint, but had equivalent efficacy, safety, and tolerability, compared with the approved On/Off regimen. The results reinforce the appropriateness of the approved dosing regimen.
Authors
- Art Wamil
- Angela Genge (ORCID: https://orcid.org/0000-0001-5587-9946)
- Manabu Doyu (ORCID: https://orcid.org/0000-0002-6264-9927)
- Fumihiro Takahashi (ORCID: https://orcid.org/0000-0001-5701-5332)
- Masashi Aoki (ORCID: https://orcid.org/0000-0001-7284-1069)
- A. Chio
- Daniel Selness
- Marvin Chum (ORCID: https://orcid.org/0000-0002-2252-0846)
- Vesna Todorović
- Lorne Zinman
- Hiide Yoshino
- Michelle Cecic
- Nissim Sasson
- Stephen Apple
- Jeffrey Rothstein
- Gen Sobue
- Manabu Hirai
- Shari De Silva
Institutions
- Montreal Neurological Institute and Hospital (CA)
- Sunnybrook Health Science Centre (CA)
- Johns Hopkins University (US)
- Aichi Medical University (JP)
- University of Toronto (CA)
- Tohoku University (JP)
- Johns Hopkins Medicine (US)
- McMaster University Medical Centre (CA)
- Health Sciences Centre (CA)
- Yoshino Kogyosho (Japan) (JP)
- Tanabe Research Laboratories (US)
- Vifor Pharma (United States) (US)
- University of Turin (IT)
- Nagoya University (JP)
- Rogers (United States) (US)
Publication Details
- Journal
- Muscle & Nerve
- Published
- 2025-12-23
- DOI
- https://doi.org/10.1002/mus.70120
- Primary Topic
- Amyotrophic Lateral Sclerosis Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Biogen
- Cytokinetics