Edaravone efficacy in amyotrophic lateral sclerosis with reduced forced vital capacity: Post-hoc analysis of Study 19 (MCI186-19) [clinical trial NCT01492686]

Autor: Benjamin Rix Brooks, Terry Heiman-Patterson, Martina Wiedau-Pazos, Shawn Liu, Jeffrey Zhang, Stephen Apple
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: PLoS ONE, Vol 17, Iss 6 (2022)
Druh dokumentu: article
ISSN: 1932-6203
Popis: Background Edaravone slowed the rate of functional decline in subjects with amyotrophic lateral sclerosis (ALS) in phase 3 study MCI186-19 (Study 19). One of the Study 19 inclusion criteria was forced vital capacity (FVC) ≥80% of predicted (≥80%p). Therefore, the study provided no information on edaravone efficacy in subjects with FVC Objective To address the question of the efficacy of edaravone in ALS patients with FVC Methods Post-hoc analysis of Study 19 comparing edaravone efficacy at week 48 in subjects with FVC24 ≥80%p vs Results With edaravone treatment, subjects in both the FVC24 ≥80%p and the FVC24 Conclusion ALS subjects in the Study 19 placebo arm had a slowing in disease progression, even when edaravone was added with an FVC of
Databáze: Directory of Open Access Journals
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