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000281786 041__ $$aEnglish
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000281786 1001_ $$aRudnicki, Stacy A$$b0
000281786 245__ $$aHospitalizations as an outcome measure in COURAGE-ALS.
000281786 260__ $$aAbingdon$$bTaylor Francis Group$$c2025
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000281786 520__ $$aObjective: 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% of those originally assigned placebo and 18.0% originally on reldesemtiv) experiencing an event. The largest percentage of events was classified as HR-ALS for both placebo (64%, 18/28) and reldesemtiv (76%, 44/58). In a multivariate model, only bulbar or respiratory onset disease was a significant risk factor for hospitalization. Conclusion: While most hospitalizations in COURAGE-ALS were HR-ALS, HU-ALS and HI-ALS also occurred. When using hospitalization as an endpoint in an ALS clinical trial, recording its relationship to ALS provides additional details to characterize disease burden and clinical meaningfulness of the endpoint.
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000281786 650_7 $$2Other$$aAmyotrophic lateral sclerosis
000281786 650_7 $$2Other$$aCOVID-19
000281786 650_7 $$2Other$$afast skeletal muscle troponin activator
000281786 650_7 $$2Other$$ahospitalization
000281786 650_7 $$2Other$$amotor neuron disease
000281786 650_7 $$2Other$$areldesemtiv
000281786 650_2 $$2MeSH$$aHumans
000281786 650_2 $$2MeSH$$aAmyotrophic Lateral Sclerosis: drug therapy
000281786 650_2 $$2MeSH$$aAmyotrophic Lateral Sclerosis: therapy
000281786 650_2 $$2MeSH$$aAmyotrophic Lateral Sclerosis: diagnosis
000281786 650_2 $$2MeSH$$aAmyotrophic Lateral Sclerosis: epidemiology
000281786 650_2 $$2MeSH$$aHospitalization: statistics & numerical data
000281786 650_2 $$2MeSH$$aMale
000281786 650_2 $$2MeSH$$aFemale
000281786 650_2 $$2MeSH$$aMiddle Aged
000281786 650_2 $$2MeSH$$aDouble-Blind Method
000281786 650_2 $$2MeSH$$aAged
000281786 650_2 $$2MeSH$$aOutcome Assessment, Health Care: methods
000281786 7001_ $$00000-0002-4924-7712$$aAl-Chalabi, Ammar$$b1
000281786 7001_ $$aAndrews, Jinsy A$$b2
000281786 7001_ $$aChio, Adriano$$b3
000281786 7001_ $$aCorcia, Philippe$$b4
000281786 7001_ $$00000-0001-9562-856X$$aCouratier, Philippe$$b5
000281786 7001_ $$aCudkowicz, Merit E$$b6
000281786 7001_ $$00000-0001-7556-0158$$aDe Carvalho, Mamede$$b7
000281786 7001_ $$aGenge, Angela$$b8
000281786 7001_ $$aHardiman, Orla$$b9
000281786 7001_ $$aHeiman-Patterson, Terry$$b10
000281786 7001_ $$00000-0002-2820-8183$$aHenderson, Robert D$$b11
000281786 7001_ $$00000-0001-5327-7204$$aIngre, Caroline$$b12
000281786 7001_ $$aJohnston, Wendy$$b13
000281786 7001_ $$0P:(DE-2719)2812633$$aLudolph, Albert$$b14$$udzne
000281786 7001_ $$aMaragakis, Nicholas J$$b15
000281786 7001_ $$aMiller, Timothy M$$b16
000281786 7001_ $$aMora, Jesus S$$b17
000281786 7001_ $$aPetri, Susanne$$b18
000281786 7001_ $$aSimmons, Zachary$$b19
000281786 7001_ $$aVan Den Berg, Leonard H$$b20
000281786 7001_ $$aZinman, Lorne$$b21
000281786 7001_ $$00000-0001-5699-8082$$aHerder, Katherine E$$b22
000281786 7001_ $$00000-0002-5469-1287$$aKupfer, Stuart$$b23
000281786 7001_ $$00000-0002-5597-5759$$aMalik, Fady I$$b24
000281786 7001_ $$00000-0003-0229-1131$$aMeng, Lisa$$b25
000281786 7001_ $$00000-0002-6063-174X$$aSimkins, Tyrell J$$b26
000281786 7001_ $$00009-0000-5828-5705$$aWei, Jenny$$b27
000281786 7001_ $$00000-0002-9094-0359$$aWolff, Andrew A$$b28
000281786 7001_ $$aShefner, Jeremy M$$b29
000281786 7001_ $$agroup, Courage-Als study$$b30$$eCollaboration Author
000281786 773__ $$0PERI:(DE-600)2705061-0$$a10.1080/21678421.2025.2515907$$gVol. 26, no. 7-8, p. 802 - 811$$n7-8$$p802 - 811$$tAmyotrophic lateral sclerosis & frontotemporal degeneration$$v26$$x2167-8421$$y2025
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