{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,24]],"date-time":"2026-03-24T12:15:01Z","timestamp":1774354501358,"version":"3.50.1"},"reference-count":12,"publisher":"Wiley","issue":"S1","license":[{"start":{"date-parts":[[2026,2,7]],"date-time":"2026-02-07T00:00:00Z","timestamp":1770422400000},"content-version":"vor","delay-in-days":6,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,2,1]],"date-time":"2026-02-01T00:00:00Z","timestamp":1769904000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Muscle and Nerve"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>This article provides a comprehensive overview of current and ongoing studies evaluating intravenous (IV) edaravone and edaravone oral suspension in the treatment of amyotrophic lateral sclerosis (ALS). In addition to data from clinical practice and post hoc analyses, multiple observational and interventional studies are underway to better understand the efficacy, safety, and biological impact of edaravone in clinical settings. Key studies include SUNRISE Japan, a long\u2010term postmarketing surveillance study of IV edaravone in Japanese patients with ALS; the ALS\/Motor Neuron Disease Natural History Study, a longitudinal registry designed to inform clinical trial design and track ALS progression; and the REFINE\u2010ALS study, which is actively collecting biomarker data to elucidate the pathophysiologic mechanisms influenced by edaravone. For edaravone oral suspension, United States Food and Drug Administration approval was supported by Study MT\u20101186\u2010A01, a phase 3 trial assessing safety and tolerability over 48\u2009weeks, with extension Study MT\u20101186\u2010A03. Study MT\u20101186\u2010A02, conducted as an FDA postmarketing commitment, and its extension, Study MT\u20101186\u2010A04, evaluated whether investigational once daily dosing showed superior efficacy vs. the approved on\/off dosing regimen. Collectively, these studies contribute to a growing body of evidence supporting the use of edaravone as a therapeutic option for ALS. They also underscore the importance of continued data collection from both clinical trials and clinical settings to inform optimal treatment strategies and combination therapy approaches as more agents become available in an evolving ALS treatment landscape.<\/jats:p>","DOI":"10.1002\/mus.70040","type":"journal-article","created":{"date-parts":[[2026,2,7]],"date-time":"2026-02-07T10:29:44Z","timestamp":1770460184000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Current and Ongoing Clinical Studies"],"prefix":"10.1002","volume":"73","author":[{"given":"Agessandro","family":"Abrahao","sequence":"first","affiliation":[{"name":"Division of Neurology, Department of Medicine and Harquail Centre for Neuromodulation, Sunnybrook Health Sciences Centre University of Toronto  Toronto Ontario Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lorne","family":"Zinman","sequence":"additional","affiliation":[{"name":"Division of Neurology, Department of Medicine and Harquail Centre for Neuromodulation, Sunnybrook Health Sciences Centre University of Toronto  Toronto Ontario Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3051-3953","authenticated-orcid":false,"given":"Stephen","family":"Apple","sequence":"additional","affiliation":[{"name":"Tanabe Pharma America, Inc.  Jersey City New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2026,2,7]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jns.2017.08.592"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/ncn3.12490"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1517\/14740338.3.6.525"},{"key":"e_1_2_8_5_1","unstructured":"Center for Innovation and Bioinformatics (CIB) ALS\/MND Natural History Consortium 2023 https:\/\/www.data4cures.org\/natural\u2010history\u2010consortium."},{"key":"e_1_2_8_6_1","unstructured":"Radicava (edaravone) Findings in Biomarkers From ALS (REFINE\u2010ALS). ClinicalTrials.gov Identifier: NCT04259255 2023 https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04259255."},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/mus.27768"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/mus.28451"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1002\/mus.28448"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/mus.28451"},{"key":"e_1_2_8_11_1","volume-title":"Rilutek (Riluzole). Prescribing Information","year":"2016"},{"key":"e_1_2_8_12_1","unstructured":"Radicava (Edaravone) IV and Radicava ORS (edaravone) Oral Suspension.Prescribing Information(Tanabe Pharma America Inc. 2025)."},{"key":"e_1_2_8_13_1","volume-title":"QALSODY (Tofersen) Injection. Prescribing Information","year":"2023"}],"updated-by":[{"DOI":"10.1002\/mus.70196","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T00:00:00Z","timestamp":1773273600000}}],"container-title":["Muscle &amp; Nerve"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/mus.70040","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/mus.70040","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/mus.70040","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,24]],"date-time":"2026-03-24T10:50:43Z","timestamp":1774349443000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/mus.70040"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2]]},"references-count":12,"journal-issue":{"issue":"S1","published-print":{"date-parts":[[2026,2]]}},"alternative-id":["10.1002\/mus.70040"],"URL":"https:\/\/doi.org\/10.1002\/mus.70040","archive":["Portico"],"relation":{},"ISSN":["0148-639X","1097-4598"],"issn-type":[{"value":"0148-639X","type":"print"},{"value":"1097-4598","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2]]},"assertion":[{"value":"2025-04-01","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-09-26","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-02-07","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}