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Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration Volume 24, 2023 - Issue 3-4
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Clinical Measurement

MiToS and King’s staging as clinical outcome measures in ALS: a retrospective analysis of the FORTITUDE-ALS trial

Paulos Gebrehiwet1 Cytokinetics, Incorporated, South San Francisco, CA, USACorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0002-7692-2189View further author information
ORCID Icon,
Lisa Meng1 Cytokinetics, Incorporated, South San Francisco, CA, USAView further author information
,
Stacy A. Rudnicki1 Cytokinetics, Incorporated, South San Francisco, CA, USAORCID Iconhttps://orcid.org/0000-0002-3499-5208View further author information
ORCID Icon,
Phil Sarocco1 Cytokinetics, Incorporated, South San Francisco, CA, USAView further author information
,
Jenny Wei1 Cytokinetics, Incorporated, South San Francisco, CA, USAView further author information
,
Andrew A. Wolff1 Cytokinetics, Incorporated, South San Francisco, CA, USAORCID Iconhttps://orcid.org/0000-0002-9094-0359View further author information
ORCID Icon,
Adriano Chiò2 Rita Levi Montalcini Department of Neuroscience, University of Turin, Turin, ItalyORCID Iconhttps://orcid.org/0000-0001-9579-5341View further author information
ORCID Icon,
Jinsy A. Andrews3 The Neurological Institute, Columbia University, New York, NY, USAORCID Iconhttps://orcid.org/0000-0002-3474-7140View further author information
ORCID Icon,
Angela Genge4 Montreal Neurological Institute, Montreal, QC, CanadaORCID Iconhttps://orcid.org/0000-0001-5587-9946View further author information
ORCID Icon,
Carlayne E. Jackson5 University of Texas Health Science Center, San Antonio, TX, USAORCID Iconhttps://orcid.org/0000-0002-9368-395XView further author information
ORCID Icon,
Noah Lechtzin6 Johns Hopkins School of Medicine, Baltimore, MD, USAORCID Iconhttps://orcid.org/0000-0002-9088-8749View further author information
ORCID Icon,
Timothy M. Miller7 Washington University School of Medicine, St. Louis, MO, USAORCID Iconhttps://orcid.org/0000-0002-3424-5511View further author information
ORCID Icon &
Jeremy M. Shefner8 Barrow Neurological Institute, Phoenix, AZ, USAORCID Iconhttps://orcid.org/0000-0001-5067-5602View further author information
ORCID Icon show all
Pages 304-310 | Received 11 May 2022, Accepted 28 Nov 2022, Published online: 12 Dec 2022

Figures & data

Table 1 Baseline characteristics.

Table 2 MiToS stage at baseline.

Table 3 King’s stage at baseline.

Table 4 Days of maintaining the baseline MiToS or King’s stage in the FORTITUDE-ALS trial.

Figure 1 Time to decline of ≥1 MiToS stage from baseline. p-Value from log-rank test at week 12 (end of the double-blind treatment period).

Figure 1 Time to decline of ≥1 MiToS stage from baseline. p-Value from log-rank test at week 12 (end of the double-blind treatment period).

Table 5 Progression from baseline to a later stage using MiToS or King’s staging.

Figure 2 Time to decline of ≥1 King’s stage from baseline. p-Value from log-rank test at week 12 (end of the double-blind treatment period).

Figure 2 Time to decline of ≥1 King’s stage from baseline. p-Value from log-rank test at week 12 (end of the double-blind treatment period).

Data availability statement

Data reported herein are part of a sponsor-led clinical development program that is ongoing, and thus complete datasets for the trial will not be made available with this report.

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