A Study to Evaluate Efficacy, Safety and Tolerability of CK-2127107 in Patients With ALS (FORTITUDE-ALS)

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The purpose of this study was to assess the effect of CK-2127107 (hereafter referred to as reldesemtiv) versus placebo on respiratory function and other measures of skeletal muscle function in patients with ALS. This was a phase 2, double-blind, randomized, placebo-controlled, dose ranging study of reldesemtiv in patients with ALS. Eligible patients were randomized (1:1:1:1) to receive placebo or one of three doses of reldesemtiv (150, 300, or 450 mg twice daily) for 12 weeks. Randomization was stratified by riluzole concomitant use/non-use and edaravone concomitant use/non-use. Concomitant riluzole and edaravone were allowed as long as the riluzole dose had been stable for at least 30 days prior to screening and edaravone had been taken for 2 cycles prior to screening; these drugs could not be initiated during the study. A total of 7 study visits were planned: screening, Day 1 (first dosing day), Weeks 2, 4, 8, and 12, and follow-up (4 weeks after the last dose of study drug). Study
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url: https://fair.dap.c-path.org/#/data/datasets/src_als_1003_2025_04_17
title: A Study to Evaluate Efficacy, Safety and Tolerability of CK-2127107 in Patients With ALS (FORTITUDE-ALS)
sameAs: cpath:1817
source: Critical Path Institute
creator: Cytokinetics, Inc.
species: Homo sapiens
subject: amyotrophic lateral sclerosis
keywords: Amyotrophic Lateral Sclerosis, Reldesemtiv, Placebo, Phase 2, respiratory, muscle function, ALSFRS-R, dynamometer, CK-2127107
publisher: Critical Path Institute
collection: ALS Knowledge Portal

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