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Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration Volume 22, 2021 - Issue 3-4
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Clinical Trials

A Phase 2, Double-Blind, Randomized, Dose-Ranging Trial Of Reldesemtiv In Patients With ALS

Jeremy M. Shefner1 Barrow Neurological Institute, Phoenix, AZ, USACorrespondence[email protected]
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,
Jinsy A. Andrews2 The Eleanor and Lou Gehrig ALS Center, The Neurological Institute, New York, NY, USAView further author information
,
Angela Genge3 Montreal Neurological Institute, Montreal, QC, CanadaView further author information
,
Carlayne Jackson4 University of Texas Health Science Center, San Antonio, TX, USAView further author information
,
Noah Lechtzin5 Johns Hopkins School of Medicine, Baltimore, MD, USAView further author information
,
Timothy M. Miller6 Washington University School of Medicine, St. Louis, MO, USAView further author information
,
Bettina M. Cockroft7 Cytokinetics, Inc, South San Francisco, CA, USAView further author information
,
Lisa Meng7 Cytokinetics, Inc, South San Francisco, CA, USAView further author information
,
Jenny Wei7 Cytokinetics, Inc, South San Francisco, CA, USAView further author information
,
Andrew A. Wolff7 Cytokinetics, Inc, South San Francisco, CA, USAView further author information
,
Fady I. Malik7 Cytokinetics, Inc, South San Francisco, CA, USAView further author information
,
Cynthia Bodkin8 Indiana University School of Medicine, Indianapolis, IN, USAView further author information
,
Benjamin R. Brooks9 Atrium Health Neurosciences Institute–Carolinas Neuromuscular/ALS MDA Care Center, Charlotte, NC, USAView further author information
,
James Caress10 Wake Forest Health Sciences, Winston-Salem, NC, USAView further author information
,
Annie Dionne11 CHU de Québec, Université Laval, Quebec, CanadaView further author information
,
Dominic Fee12 Medical College of Wisconsin, Milwaukee, WI, USAView further author information
,
Stephen A. Goutman13 University of Michigan, Ann Arbor, MI, USAView further author information
,
Namita A. Goyal14 The ALS & Neuromuscular Center, UCI Health, Orange, CA, USAView further author information
,
Orla Hardiman15 Trinity College, Beaumont Hospital, Dublin, IrelandView further author information
,
Ghazala Hayat16 St. Louis University, St. Louis, MO, USAView further author information
,
Terry Heiman-Patterson17 Lewis Katz School of Medicine, Temple University, Philadelphia, PA, USAView further author information
,
Daragh Heitzman18 Texas Neurology, Dallas, TX, USAView further author information
,
Robert D. Henderson19 Royal Brisbane and Women's Hospital, Herston, AustraliaView further author information
,
Wendy Johnston20 University of Alberta, Edmonton, AB, CanadaView further author information
,
Chafic Karam21 Oregon Health & Science University, Portland, OR, USAView further author information
,
Matthew C. Kiernan22 Royal Prince Alfred Hospital, University of Sydney, Sydney, AustraliaView further author information
,
Stephen J. Kolb23 Wexner Medical Center, Ohio State University, Columbus, OH, USAView further author information
,
Lawrence Korngut24 University of Calgary, Calgary, AB, CanadaView further author information
,
Shafeeq Ladha25 St. Joseph's Hospital and Medical Center, Neurological Institute, AZ, USABarrow PhoenixView further author information
,
Genevieve Matte26 Centre Hospitalier de l’Université de Montréal, Montreal, QC, CanadaView further author information
,
Jesus S. Mora27 Hospital San Rafael, Madrid, GermanyView further author information
,
Merrilee Needham28 Perron Institute, Department of Neurology, Fiona Stanley Hospital, The University of Notre Dame Australia, Murdoch University, Perth, AustraliaView further author information
,
Bjorn Oskarsson29 Mayo Clinic Florida, Jacksonville, FL, USAORCID Iconhttps://orcid.org/0000-0002-1725-9866View further author information
ORCID Icon,
Gary L. Pattee30 Neurology Associates, Lincoln, NE, USAView further author information
,
Erik P. Pioro31 Cleveland Clinic, Cleveland, OH, USAView further author information
,
Michael Pulley32 University of Florida, Jacksonville, FL, USAView further author information
,
Dianna Quan33 University of Colorado Denver, Aurora, CO, USAView further author information
,
Kourosh Rezania34 University of Chicago Medical Center, Chicago, IL, USAView further author information
,
Kerri L. Schellenberg35 University of Saskatchewan, Saskatoon, SK, CanadaORCID Iconhttps://orcid.org/0000-0002-5820-2428View further author information
ORCID Icon,
David Schultz36 Flinders Medical Centre, Bedford Park, AustraliaView further author information
,
Christen Shoesmith37 London Health Sciences Centre, London, ON, CanadaView further author information
,
Zachary Simmons38 Penn State Hershey Medical Center, Hershey, PA, USAView further author information
,
Jeffrey Statland39 University of Kansas Medical Center, Kansas City, KS, USAView further author information
,
Shumaila Sultan40 West Virginia University, Morgantown, WV, USAView further author information
,
Andrea Swenson41 University of Iowa, Iowa City, IA, USAView further author information
,
Leonard H. Van Den Berg42 Department of Neurology, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, The NetherlandsView further author information
,
Tuan Vu43 University of South Florida, Tampa, FL, USAView further author information
,
Steve Vucic44 Westmead Hospital, Sydney, AustraliaView further author information
,
Michael Weiss45 University of Washington, Seattle, WA, USAView further author information
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Ashley Whyte-Rayson46 Duke University School of Medicine, Durham, NC, USAView further author information
,
James Wymer47 University of Florida, Gainesville, FL, USAView further author information
,
Lorne Zinman48 ALS/Neuromuscular Clinic Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, CanadaView further author information
&
Stacy A. Rudnicki7 Cytokinetics, Inc, South San Francisco, CA, USAView further author information
 show all
Pages 287-299 | Received 07 May 2020, Accepted 03 Sep 2020, Published online: 24 Sep 2020

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Paulos Gebrehiwet, Lisa Meng, Stacy A. Rudnicki, Phil Sarocco, Jenny Wei, Andrew A. Wolff, Michael Butzner, Adriano Chiò, Jinsy A. Andrews, Angela Genge, Dyfrig A. Hughes, Carlayne E. Jackson, Noah Lechtzin, Timothy M. Miller & Jeremy M. Shefner. (2023) Health utilities and quality-adjusted life years for patients with amyotrophic lateral sclerosis receiving reldesemtiv or placebo in FORTITUDE-ALS. Journal of Medical Economics 26:1, pages 488-493.
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Jeremy M. Shefner, Bill Jacobsen, Stuart Kupfer, Fady I. Malik, Lisa Meng, Jenny Wei, Andrew A Wolff & Stacy A. Rudnicki. (2023) Relationship between quantitative strength and functional outcomes in the phase 2 FORTITUDE-ALS trial. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 0:0, pages 1-8.
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Jeremy M. Shefner, Ammar Al-Chalabi, Jinsy A. Andrews, Adriano Chio, Mamede De Carvalho, Bettina M. Cockroft, Philippe Corcia, Philippe Couratier, Merit E. Cudkowicz, Angela Genge, Orla Hardiman, Terry Heiman-Patterson, Robert D. Henderson, Caroline Ingre, Carlayne E. Jackson, Wendy Johnston, Noah Lechtzin, Albert Ludolph, Nicholas J. Maragakis, Timothy M. Miller, Jesus S. Mora Pardina, Susanne Petri, Zachary Simmons, Leonard H. Van Den Berg, Lorne Zinman, Stuart Kupfer, Fady I. Malik, Lisa Meng, Tyrell J. Simkins, Jenny Wei, Andrew A. Wolff & Stacy A. Rudnicki. (2023) COURAGE-ALS: a randomized, double-blind phase 3 study designed to improve participant experience and increase the probability of success. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 24:5-6, pages 523-534.
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Paulos Gebrehiwet, Lisa Meng, Stacy A. Rudnicki, Phil Sarocco, Jenny Wei, Andrew A. Wolff, Adriano Chiò, Jinsy A. Andrews, Angela Genge, Carlayne E. Jackson, Noah Lechtzin, Timothy M. Miller & Jeremy M. Shefner. (2023) MiToS and King’s staging as clinical outcome measures in ALS: a retrospective analysis of the FORTITUDE-ALS trial. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 24:3-4, pages 304-310.
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Loreto Martinez-Gonzalez & Ana Martinez. (2023) Emerging clinical investigational drugs for the treatment of amyotrophic lateral sclerosis. Expert Opinion on Investigational Drugs 32:2, pages 141-160.
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. (2022) Theme 09 - Clinical Trials and Trial Design. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 23:sup1, pages 133-149.
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Stacy A. Rudnicki, Jinsy A. Andrews, Angela Genge, Carlayne Jackson, Noah Lechtzin, Timothy M. Miller, Bettina M. Cockroft, Fady I. Malik, Lisa Meng, Jenny Wei, Andrew A. Wolff & Jeremy M. Shefner. (2022) Prescription and acceptance of durable medical equipment in FORTITUDE-ALS, a study of reldesemtiv in ALS: post hoc analyses of a randomized, double-blind, placebo-controlled clinical trial. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 23:3-4, pages 263-270.
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Ruben P.A. van Eijk, Adriaan D. de Jongh, Stavros Nikolakopoulos, Christopher J. McDermott, Marinus J.C. Eijkemans, Kit C.B. Roes & Leonard H. van den Berg. (2021) An old friend who has overstayed their welcome: the ALSFRS-R total score as primary endpoint for ALS clinical trials. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 22:3-4, pages 300-307.
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Muzammil Arif Din Abdul Jabbar, Ling Guo, Sonakshi Nag, Yang Guo, Zachary Simmons, Erik P. Pioro, Savitha Ramasamy & Crystal Jing Jing Yeo. Predicting amyotrophic lateral sclerosis (ALS) progression with machine learning. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 0:0, pages 1-14.
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Jeremy M. Shefner, Tommy Bunte, Gale Kittle, Angela Genge & Leonard H van den Berg. Harmonized standard operating procedures for administering the ALS functional rating scale-revised. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration 0:0, pages 1-8.
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Yuliya Lakhina, Nicholas M. Boulis & Anthony Donsante. Current and emerging targeted therapies for spinal muscular atrophy. Expert Review of Neurotherapeutics 0:0, pages 1-11.
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