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Quick Info
Status
Currently Recruiting
Phase
3
Trial Type
Interventional
Treatment Type
Drug Trials
Randomization
2:1
Enrollment
555
Start Date
8/16/2021
Sponsor
Contact Information
    Contact information unknown.
Locations
Australia, Other
Flinders Medical Centre, Bedford Park, 5042, Australia
Contact: Eldira Dishnica   +61 (08) 8204 5168
Brain and Mind Centre, Camperdown, 2050, Australia
Contact: Matthew Kiernan
Concord Repatriation General Hospital, Concord, 2139, Australia
Contact: Steve Vucic
Royal Brisbane and Women's Hospital, Herston, 4029, Australia
Contact: Susan Heggie
The Perron Institute, Nedlands, 6009, Australia
Contact: Merrilee Needham
Belgium, Other
UZ Leuven Gasthuisberg, Department of Neurology, Leuven, 3000, Belgium
Contact: Philip Van Damme
Canada, Alberta
University of Calgary - Heritage Medical Research Clinic, Calgary, AB, T2N 4Z6, Canada
Contact: Li Pi Shan Rodney
University of Alberta, Edmonton, AB, T6G 2B7, Canada
Contact: Wendy Johnston
Canada, New Brunswick
Stan Cassidy Centre for Rehabilitation, Fredericton, NB, E3B 0C7, Canada
Contact: Colleen O'Connell
Canada, Ontario
McMaster University Medical Centre, Hamilton, ON, L8N 3Z5, Canada
Contact: John Turnbull
London Health Sciences Centre, London, ON, N6A 5A5, Canada
Contact: Christen Shoesmith   Christen.Shoesmith@lhsc.on.ca
Ottawa Hospital Research Institute - Civic Campus, Ottawa, ON, K1Y 4E9, Canada
Contact: Ariel Breiner
Sunnybrook Research Institute, Toronto, ON, M4N 3M5, Canada
Contact: Lorne Zinman
Canada, Quebec
Centre de recherche du CHUM, Montréal, QC, H2X 0A9, Canada
Contact: Genevieve Matte
McGill University, Montreal Neurological Institute & Hospital, Montréal, QC, H3A 2B4, Canada
Contact: Angela Genge   als-cru.neuro@mcgill.ca
CHU de Quebec-Université Laval, Québec, QC, G1J 1Z4, Canada
Contact: Annie Dionne
Canada, Saskatchewan
Saskatoon City Hospital, Saskatoon, SK, S7K 0M7, Canada
Contact: Kerri Schellenberg
France, Other
CRC SLA de Lyon, Bron, 69677, France
CHRU de Lille Hopital Roger Salengro, Lille, 59037, France
CHU de Limoges - Hopital Dupuytren, Limoges, 87 042, France
Contact: Couratier Philippe
CHU de la Timone, Marseille, 13005, France
Contact: Shahram Attarian
CHU de Nice - Hôpital Pasteur 2, Nice, 06 001, France
Contact: Marie-Helene Soriani
Hopital La Pitie Salpetriere, Paris, 75013, France
Contact: Francois Salachas
CHRU de Tours, Hopital Bretonneau, Clinical Research Center, Tours, 37044, France
Contact: Philippe Corcia, Pr.
Germany, Other
Charité - Universitätsmedizin Berlin, Berlin, 13353, Germany
Universitatsklinikum Bonn, Bonn, 53127, Germany
Contact: Patrick Weydt
Medical School Hannover - Department of Neurology, Hanover, 30625, Germany
Contact: Susanne Petri
Universitatsklinikum Jena, Jena, 07747, Germany
Contact: Annekathrin Rodiger
Universitätsklinikum Schleswig Holstein, Lübeck, 23538, Germany
Contact: Grosskreutz Julian
Universitatsklinikum Ulm, Ulm, 89081, Germany
Contact: Albert C. Ludolph, Prof. Dr.
Ireland, Other
RSCI Education and Research Centre, Beaumont Hospital, Beaumont, 9, Ireland
Contact: Orla Hardiman
Italy, Other
Ospedale San Luca, Milan, 20149, Italy
Contact: Vincenzo Silani   neurotrial@auxologico.it
Centro Clinical Nemo - Fondazione Serena Onlus, Milan, 20162, Italy
Contact: Christian Lunetta
Instituti Clinici Scientifici Maugeri, Milano, 20138, Italy
AOU Città della Salute e Scienza (Molinette),, Turin, 10126, Italy
Contact: Andrea Calvo
Netherlands, Other
UMC Utrecht, Department of Neurology, ALS Center, Utrecht, 3584 CX, Netherlands
Contact: L.H. van den Berg, Dr.
Poland, Other
City Clinic Research, Warsaw, 02-473, Poland
Contact: Magdalena Kuzma-Kozakiewicz
Portugal, Other
Centro Hospitalar Universitario Lisboa Norte, Department of Neurology, Lisboa, 1649-035, Portugal
Contact: Mamede Carvalho
Spain, Other
Hospital Universitari de Bellvitge, Barcelona, 08907, Spain
Contact: Monica Povedano
Hospital Universitario Basurto, Bilbao, 48013, Spain
Contact: Luis Varona Franco
Hospital San Rafael, Madrid, 28016, Spain
Contact: Jesus Mora
Hospital Universitari i Politecnic La Fe, Valencia, 46026, Spain
Contact: Juan Francisco Vazquez Costa
Sweden, Other
Studieenheten Akademiskt Specialistcentrum, Sabbatsberg Hospital, Stockholm, 11361, Sweden
Contact: Caroline Ingre
Switzerland, Other
Muskelzentrum/ALS Clinic, Saint Gallen, 9007, Switzerland
Contact: Markus Weber, MD
United Kingdom, Other
The Walton Centre NHS Foundation Trust, Liverpool, L9 7LJ, United Kingdom
Contact: Carolyn Young
Maurice Wohl Clinical Neuroscience Institute, London, SE5 9RX, United Kingdom
Contact: Ammar Al-Chalabi
United States, Arizona
St. Joseph's Hospital & Medical Center - Barrow Neurological Institute, Phoenix, AZ, 85013, United States
Contact: Annalee Boyle, MD   602-406-7773   fulton.research@dignityhealth.org
United States, California
Cedars-Sinai Medical Center, Los Angeles, CA, 90048, United States
Contact: Richard Lewis, MD
University of California Irvine - ALS & Neuromuscular Center, Orange, CA, 92868, United States
Contact: Namita Goyal, MD
California Pacific Medical Center - Forbes Norris MDA/ALS Research Center, San Francisco, CA, 94109, United States
Contact: Jonathan Katz, MD
Stanford Hospital and Clinics, Stanford, CA, 94305, United States
Contact: Yuen T. So, MD, PhD   650-725-4341   neuromuscularresearch@stanford.edu
United States, Colorado
University of Colorado Hospital Anschutz Outpatient Pavilion, Aurora, CO, 80045, United States
Contact: 303-724-4644   neuroresearch@cuanschutz.edu
United States, District of Columbia
GW Medical Faculty Associates, Washington, DC, 20037, United States
Contact: Elham Bayat, MD
United States, Florida
University of Florida Jacksonville, Jacksonville, FL, 32209, United States
Contact: Michael Pulley, MD, PhD
Mayo Clinic Florida, Jacksonville, FL, 32224, United States
Contact: Bjorn E. Oskarsson, MD
University of South Florida - Carol and Frank Morsani Center for Advanced Health Care, Tampa, FL, 33612, United States
Contact: Tuan H. Vu, MD
United States, Illinois
Duchossois Center for Advanced Medicine, Chicago, IL, 60637, United States
Contact: Kourosh Rezania
United States, Indiana
Indiana University, Indianapolis, IN, 46202, United States
Contact: Cynthia Bodkin, MD
United States, Iowa
University of Iowa Hospitals and Clinics, Iowa City, IA, 52242, United States
Contact: Andrea Swenson
United States, Kansas
The University of Kansas Medical Center, Kansas City, KS, 66160, United States
Contact: Jeffrey M. Statland, MD
United States, Maryland
Johns Hopkins Outpatient Center, Baltimore, MD, 21287, United States
Contact: Jeffrey D. Rothstein, MD, PhD
United States, Massachusetts
Massachusetts General Hospital - Neurological Clinical Research Institute, Boston, MA, 02114, United States
Contact: Sabrina Paganoni, MD, PhD
University of Massachusetts Memorial Medical Center/Medical School, Worcester, MA, 01655, United States
Contact: Margaret A. Owegi, DO
United States, Michigan
Michigan Medicine, Ann Arbor, MI, 48109, United States
Contact: Stephen A. Goutman, MD, MS
Henry Ford Health System, Detroit, MI, 48202, United States
Contact: Ximena Arcila-Londono, MD
United States, Missouri
Washington University School of Medicine - Center for Advance Medicine, Saint Louis, MO, 63108, United States
Contact: TImothy M. Miller, MD, PhD
United States, Nebraska
Neurology Associates, PC, Lincoln, NE, 68506, United States
Contact: Gary L. Pattee, MD
United States, New York
Hospital for Special Surgery, New York, NY, 10021, United States
Contact: Dale J. Lange
Columbia University Medical Center, New York, NY, 10032, United States
Contact: Jinsy Andrews, MD, MSc
University of Rochester Medical Center, Rochester, NY, 14642, United States
SUNY Upstate Medical University, Syracuse, NY, 13210, United States
Contact: Deborah Bradshaw, MD
United States, North Carolina
Atrium Health Neuroscience Institute - Charlotte, Charlotte, NC, 28207, United States
Contact: Leo McCluskey
United States, Ohio
Cleveland Clinic, Cleveland, OH, 44195, United States
Contact: Rebecca Kuenzler, MD
United States, Oregon
Providence ALS Center, Portland, OR, 97213, United States
Contact: Nicholas T. Olney, MD
Oregon Health and Science University, Portland, OR, 97239, United States
Contact: Yvel Maspinas   maspinas@ohsu.edu
United States, Pennsylvania
Penn State Health Milton S. Hershey Medical Center, Hershey, PA, 17033, United States
Contact: James Grogan, MD
Lewis Katz School of Medicine at Temple University, Philadelphia, PA, 19140, United States
Contact: Terry Heiman-Patterson, MD
United States, Tennessee
Vanderbilt University Medical Center - Clinical Research Center, Nashville, TN, 37232, United States
Contact: Amanda C. Peltier, MD
United States, Texas
Texas Neurology, P.A., Dallas, TX, 75206, United States
Contact: Daragh Heitzman, MD
United States, Vermont
University of Vermont Medical Center, Burlington, VT, 05401, United States
Contact: Rup Tandan, MD
United States, Virginia
VCU Neuroscience Orthopaedic and Wellness Center (NOW), Henrico, VA, 23233, United States
Contact: Kelly Gwathmey, MD
United States, Wisconsin
Froedtert Hospital, Milwaukee, WI, 53226, United States
Contact: Dominic Fee, MD
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
>65%
Months Since Onset
Number of months since first symptoms of ALS.
<24 Months
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
Yes
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
Yes
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Yes
Open Label
No
Update Notes
New site added
10/25/2022
Site contact updates
9/27/2022
New site added
9/22/2022
Site contact updates
8/22/2022
Updating trial name to add COURAGE-ALS. -NS
8/2/2022
New site added
8/2/2022
New sites added
6/6/2022
Site contact updates
5/17/2022
Sites updated
5/4/2022
Site contacts
4/19/2022
New site added
4/11/2022
Sites added
4/5/2022
Site contacts updated
3/23/2022
New site added
3/16/2022
Sites added, contact updates
3/10/2022
New site added
3/3/2022
Site contact updates
2/25/2022
Site added, contact updates
2/17/2022
Site update
2/14/2022
Sites added
1/31/2022
Site added
1/25/2022
Site added
1/12/2022
Site added
12/28/2021
Sites added/updated
12/21/2021
Sites added
12/8/2021
Site added
11/30/2021
New site added
11/16/2021
New site added
10/22/2021
New site added
10/13/2021
New site added
10/7/2021
New site added
10/5/2021
Site added
9/28/2021
New sites added
9/24/2021
New site added
9/15/2021
Study start updated, new site added
9/9/2021
New site added
8/31/2021
New sites added
8/26/2021
New sites added
8/20/2021
Site contacts updated
8/17/2021
Sites added
8/12/2021
Study recruiting, sites added
8/4/2021
Study added
7/1/2021

Other Information

Purpose
The purpose of this study is to assess the effect of reldesemtiv versus placebo on functional outcomes in ALS.
Eligibility
Key Inclusion Criteria:
- Males or Females between the ages of 18 and 80 years of age, inclusive - Diagnosis of familial or sporadic ALS (defined as meeting the laboratory-supported probable, probable, or definite criteria for ALS according to the World Federation of Neurology El Escorial criteria). Patients who meet the possible criteria are eligible if they have lower motor neuron findings; those who have purely upper motor neuron findings are ineligible.
- First symptom of ALS ≤ 24 months prior to screening. The qualifying first symptoms of ALS are limited to manifestations of weakness in extremity, bulbar, or respiratory muscles.
- ALSFRS-R total score ≤ 44 at screening. Patients with a total score of 45 or higher may be rescreened 60±7 days following the original screening date.
- Upright FVC ≥ 65.0% of predicted for age, height, sex and ethnicity at screening according to Global Lung Initiative equation - Must be either on riluzole for ≥ 30 days prior to screening or have not taken it for at least 30 days prior to screening - Must have completed at least 2 cycles of edaravone at the time of screening or have not received it for at least 30 days prior to screening - Able to swallow whole tablets Exclusion Criteria:
- eGFRCysC < 45.0 mL/min/1.73 m2 at screening - Urine protein/creatinine ratio > 1 mg/mg (113 mg/mmol) at screening - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3-times the upper limit of normal (ULN) - Total bilirubin (TBL), direct or indirect bilirubin above the ULN.
- Cognitive impairment, related to ALS or otherwise that impairs the patient's ability to understand and/or comply with study procedures and provide informed consent - Other medically significant neurological conditions that could interfere with the assessment of ALS symptoms, signs or progression.
- Has a tracheostomy
Details
COURAGE-ALS is a Phase 3, double-blind, randomized, placebo-controlled trial of reldesemtiv in patients aged 18 to 80 with ALS. The screening and qualification period for the trial will be no more than 14 days in duration. Approximately 555 eligible ALS patients will be randomized (2:1) to receive the following dose of reldesemtiv or placebo (stratified by riluzole use/non-use and edaravone use/non-use) for the first 24 weeks (double-blind, placebo-controlled period): - 300 mg reldesemtiv twice a day for a 600 mg total daily dose (TDD) - Placebo twice daily At the end of the 24-week double-blind, placebo-controlled period, patients will transition to the active drug period, where all patients will receive the following dose of reldesemtiv for the next 24 weeks: - 300 mg reldesemtiv twice a day for a 600 mg TDD for patients who were not down titrated during the 24 weeks of blinded dosing - 150 mg reldesemtiv twice a day for a 300 mg TDD for patients who were down titrated during the 24 weeks of blinded dosing
Collaborator(s)
  • Cytokinetics
Trial Protocol as Published on Clinicaltrials.gov
NCT04944784 (First Published: 6/16/2021)