TY  - JOUR
AU  - Rudnicki, Stacy A
AU  - Al-Chalabi, Ammar
AU  - Andrews, Jinsy A
AU  - Chio, Adriano
AU  - Corcia, Philippe
AU  - Couratier, Philippe
AU  - Cudkowicz, Merit E
AU  - De Carvalho, Mamede
AU  - Genge, Angela
AU  - Hardiman, Orla
AU  - Heiman-Patterson, Terry
AU  - Henderson, Robert D
AU  - Ingre, Caroline
AU  - Johnston, Wendy
AU  - Ludolph, Albert
AU  - Maragakis, Nicholas J
AU  - Miller, Timothy M
AU  - Mora, Jesus S
AU  - Petri, Susanne
AU  - Simmons, Zachary
AU  - Van Den Berg, Leonard H
AU  - Zinman, Lorne
AU  - Herder, Katherine E
AU  - Kupfer, Stuart
AU  - Malik, Fady I
AU  - Meng, Lisa
AU  - Simkins, Tyrell J
AU  - Wei, Jenny
AU  - Wolff, Andrew A
AU  - Shefner, Jeremy M
TI  - Hospitalizations as an outcome measure in COURAGE-ALS.
JO  - Amyotrophic lateral sclerosis & frontotemporal degeneration
VL  - 26
IS  - 7-8
SN  - 2167-8421
CY  - Abingdon
PB  - Taylor Francis Group
M1  - DZNE-2025-01179
SP  - 802 - 811
PY  - 2025
AB  - Objective: To describe the development of a methodology to characterize hospitalizations and their relationship to amyotrophic lateral sclerosis (ALS) and provide results using this process in a phase 3 trial of reldesemtiv in ALS. Methods: ALS clinical trialists assisted in developing a classification system to determine if a hospitalization was related to ALS (HR-ALS), unrelated (HU-ALS), or if the relationship was indeterminate (HI-ALS) and this was applied by the investigators to hospitalizations in COURAGE-ALS. Time to first hospitalization and number of hospitalizations were compared between those assigned reldesemtiv or placebo for up to 48 weeks. Demographic and clinical features were evaluated for prediction of hospitalization risk; this analysis was limited to those participants who completed the first 24-week double-blind placebo-controlled portion of the trial. Results: COURAGE-ALS terminated early due to futility. Time to first hospitalization was similar in the reldesemtiv compared to placebo arms as was the incidence, with 86 of the participants (17.6
KW  - Humans
KW  - Amyotrophic Lateral Sclerosis: drug therapy
KW  - Amyotrophic Lateral Sclerosis: therapy
KW  - Amyotrophic Lateral Sclerosis: diagnosis
KW  - Amyotrophic Lateral Sclerosis: epidemiology
KW  - Hospitalization: statistics & numerical data
KW  - Male
KW  - Female
KW  - Middle Aged
KW  - Double-Blind Method
KW  - Aged
KW  - Outcome Assessment, Health Care: methods
KW  - Amyotrophic lateral sclerosis (Other)
KW  - COVID-19 (Other)
KW  - fast skeletal muscle troponin activator (Other)
KW  - hospitalization (Other)
KW  - motor neuron disease (Other)
KW  - reldesemtiv (Other)
LB  - PUB:(DE-HGF)16
C6  - pmid:40503807
DO  - DOI:10.1080/21678421.2025.2515907
UR  - https://pub.dzne.de/record/281786
ER  -