{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,12]],"date-time":"2026-05-12T19:30:08Z","timestamp":1778614208481,"version":"3.51.4"},"reference-count":6,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2025,6,9]],"date-time":"2025-06-09T00:00:00Z","timestamp":1749427200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Muscle and Nerve"],"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Introduction\/Aims<\/jats:title><jats:p>Edaravone intravenous (IV) and oral suspension have been shown to have similar pharmacokinetics, safety, and slowing of functional decline in patients with amyotrophic lateral sclerosis (ALS). Study MT\u20101186\u2010A01 indicated that edaravone oral suspension was well\u2010tolerated over 48\u2009weeks, with no new safety concerns identified relative to existing safety data of IV edaravone, including Study MCI186\u201019. The aim of this study was to assess the long\u2010term safety and tolerability of edaravone oral suspension in patients with ALS.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Study MT\u20101186\u2010A03 (NCT04577404) was a phase 3, open\u2010label, multi\u2010center, extension study that evaluated the long\u2010term safety of edaravone oral suspension over an additional 96\u2009weeks in patients with ALS who have completed the initial 48\u2009weeks of Study MT\u20101186\u2010A01, for a total of up to 144\u2009weeks of treatment. Patients received a 105\u2010mg dose of edaravone administered in treatment cycles identical to the approved edaravone on\/off dosing schedule. Patients had definite, probable, probable\u2010laboratory\u2010supported, or possible ALS.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In Study MT\u20101186\u2010A03, edaravone oral suspension was well tolerated with no new safety concerns. The most common treatment\u2010emergent adverse events (TEAEs) were fall, muscular weakness, dyspnea, constipation, and dysphagia. These TEAEs were consistent with the safety profile for edaravone from previous clinical trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>These results help establish the long\u2010term safety and tolerability profile of edaravone oral suspension.<\/jats:p><\/jats:sec>","DOI":"10.1002\/mus.28451","type":"journal-article","created":{"date-parts":[[2025,6,9]],"date-time":"2025-06-09T05:03:34Z","timestamp":1749445414000},"page":"450-454","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Safety Extension Study of Edaravone Oral Suspension in Patients With Amyotrophic Lateral Sclerosis for up to an Additional 96\u2009Weeks of Treatment"],"prefix":"10.1002","volume":"72","author":[{"given":"Angela","family":"Genge","sequence":"first","affiliation":[{"name":"Montreal Neurological Institute and Hospital  Montreal Quebec Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8365-6707","authenticated-orcid":false,"given":"Gary L.","family":"Pattee","sequence":"additional","affiliation":[{"name":"University of Nebraska Medical Center  Lincoln Nebraska USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gen","family":"Sobue","sequence":"additional","affiliation":[{"name":"Nagoya University Graduate School of Medicine  Nagoya Japan"},{"name":"Aichi Medical University  Nagakute Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masashi","family":"Aoki","sequence":"additional","affiliation":[{"name":"Tohoku University School of Medicine  Sendai Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiide","family":"Yoshino","sequence":"additional","affiliation":[{"name":"Neurology Clinic  Chiba Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Philippe","family":"Couratier","sequence":"additional","affiliation":[{"name":"CRMR SLA Service de Neurologie, CHU de Limoges  Limoges France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"Lunetta","sequence":"additional","affiliation":[{"name":"Istituti Clinici Scientifici Maugeri IRCCS, Neurorehabilitation Unit of Milano  Milan Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susanne","family":"Petri","sequence":"additional","affiliation":[{"name":"Hannover Medical School  Hannover Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"Selness","sequence":"additional","affiliation":[{"name":"Mitsubishi Tanabe Pharma America, Inc.  Jersey City New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vesna","family":"Todorovic","sequence":"additional","affiliation":[{"name":"Mitsubishi Tanabe Pharma Europe Ltd.  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nissim","family":"Sasson","sequence":"additional","affiliation":[{"name":"NStat Solutions, Biostatistical Services  Rehovot Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manabu","family":"Hirai","sequence":"additional","affiliation":[{"name":"Mitsubishi Tanabe Pharma America, Inc.  Jersey City New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fumihiro","family":"Takahashi","sequence":"additional","affiliation":[{"name":"Mitsubishi Tanabe Pharma America, Inc.  Jersey City New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alejandro","family":"Salah","sequence":"additional","affiliation":[{"name":"Mitsubishi Tanabe Pharma America, Inc.  Jersey City New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3051-3953","authenticated-orcid":false,"given":"Stephen","family":"Apple","sequence":"additional","affiliation":[{"name":"Mitsubishi Tanabe Pharma America, Inc.  Jersey City New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Art","family":"Wamil","sequence":"additional","affiliation":[{"name":"Mitsubishi Tanabe Pharma America, Inc.  Jersey City New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexander","family":"Kalin","sequence":"additional","affiliation":[{"name":"Mitsubishi Tanabe Pharma America, Inc.  Jersey City New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carlayne E.","family":"Jackson","sequence":"additional","affiliation":[{"name":"University of Texas Health Science Center at San Antonio  San Antonio Texas USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,6,9]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"MTPA \u201cRadicava (Edaravone) IV and Radicava ORS (Edaravone) Oral Suspension.\u201dPrescribing Information. Jersey City NJ: Mitsubishi Tanabe Pharma Corporation; November 2022."},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(17)30115-1"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.925"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.952"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/mus.27768"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.2011.10111704"}],"container-title":["Muscle &amp; Nerve"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/mus.28451","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,8,11]],"date-time":"2025-08-11T14:14:29Z","timestamp":1754921669000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/mus.28451"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,6,9]]},"references-count":6,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2025,9]]}},"alternative-id":["10.1002\/mus.28451"],"URL":"https:\/\/doi.org\/10.1002\/mus.28451","archive":["Portico"],"relation":{},"ISSN":["0148-639X","1097-4598"],"issn-type":[{"value":"0148-639X","type":"print"},{"value":"1097-4598","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,6,9]]},"assertion":[{"value":"2024-10-17","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-05-27","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-06-09","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}