{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["82(5)"],"submitter":["Shefner JM"],"pubmed_abstract":["<h4>Importance</h4>Treatment options for amyotrophic lateral sclerosis (ALS) remain suboptimal. Results from a phase 2 study of reldesemtiv in ALS suggested that it may slow disease progression.<h4>Objective</h4>To assess the effect of reldesemtiv vs placebo on functional outcomes in ALS.<h4>Design, setting, and participants</h4>A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (COURAGE-ALS) was a double-blind, placebo-controlled phase 3 randomized clinical trial conducted at 83 ALS centers in 16 countries from August 2021 to July 2023. The first 24-week period was placebo controlled vs reldesemtiv. All participants received reldesemtiv during the second 24-week period with a 4-week follow-up. Two interim analyses were planned, the fi"],"journal":["JAMA neurology"],"pagination":["477-485"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC11933997"],"repository":["biostudies-literature"],"pubmed_title":["Reldesemtiv in Amyotrophic Lateral Sclerosis: Results From the COURAGE-ALS Randomized Clinical Trial."],"pmcid":["PMC11933997"],"pubmed_authors":["Johnston W","van den Berg LH","Quan D","Creigh P","Young C","Fee D","Maragakis NJ","Statland J","Grogan J","Zwicker J","Rezania K","COURAGE-ALS Study Group","Couratier P","Kusma-Kozakiewicz M","Goyal N","Vucic S","Shoesmith C","So Y","Meyer T","Großkreutz J","Rodiger A","Simkins TJ","Kiernan MC","Chahin N","Shefner JM","Kuenzler R","Zinman L","Gwathmey K","Vazquez-Costa JF","Tandan R","Schultz D","Pavlakis P","Soriani MH","Bodkin C","Ludolph A","Bayat E","Turnbull J","Lewis R","Hardiman O","Katz J","Miller TM","Salachas F","Goutman S","Owegi M","Andrews JA","Dionne A","Rothstein J","Calvo A","Simmons Z","Kupfer S","Attarian S","Lunetta C","Patee G","Mccluskey LH","Pulley M","Mora JS","Matte G","Swenson A","Ladha S","Bradshaw D","Petri S","Oskarrson B","Salveson L","Nilsson C","Cudkowicz ME","Povedano M","Silani V","Needham M","Cerri F","Wei J","Genge A","Paganoni S","Weber M","Henderson RD","Ingre C","Weydt P","Danel V","Olney N","Rudnicki SA","Corcia P","Schellenberg K","de Carvalho M","Heiman-Patterson T","O'Connell CM","Malik FI","Arcilla-London X","Chio A","Al-Chalabi A","Peltier A","Meng L","Bernard E","Vu T","Wolff AA","Korngut L","Heitzman D"],"additional_accession":[]},"is_claimable":false,"name":"Reldesemtiv in Amyotrophic Lateral Sclerosis: Results From the COURAGE-ALS Randomized Clinical Trial.","description":"<h4>Importance</h4>Treatment options for amyotrophic lateral sclerosis (ALS) remain suboptimal. Results from a phase 2 study of reldesemtiv in ALS suggested that it may slow disease progression.<h4>Objective</h4>To assess the effect of reldesemtiv vs placebo on functional outcomes in ALS.<h4>Design, setting, and participants</h4>A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (COURAGE-ALS) was a double-blind, placebo-controlled phase 3 randomized clinical trial conducted at 83 ALS centers in 16 countries from August 2021 to July 2023. The first 24-week period was placebo controlled vs reldesemtiv. All participants received reldesemtiv during the second 24-week period with a 4-week follow-up. Two interim analyses were planned, the fi","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 May","modification":"2026-06-01T10:16:09.289Z","creation":"2025-07-13T03:04:54.398Z"},"accession":"S-EPMC11933997","cross_references":{"pubmed":["40126464"],"doi":["10.1001/jamaneurol.2025.0241"]}}