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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
Canada, Alberta
University of Calgary - Heritage Medical Research Clinic, Calgary, AB, T2N 4Z6, Canada
Contact: Lawrence Korngut
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
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
McGill University, Montreal Neurological Institute & Hospital, Montréal, QC, H3A 2B4, Canada
Contact: Angela Genge
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
United States, Arizona
St. Joseph's Hospital & Medical Center - Barrow Neurological Institute, Phoenix, AZ, 85013, United States
Contact: Shafeeq Ladha, MD
United States, California
Stanford Hospital and Clinics, Stanford, CA, 94305, United States
Contact: Yuen T. So, MD, PhD
United States, Florida
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, 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, 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
SUNY Upstate Medical University, Syracuse, NY, 13210, United States
Contact: Deborah Bradshaw, 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
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
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)