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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05442775
Registration number
NCT05442775
Ethics application status
Date submitted
16/06/2022
Date registered
5/07/2022
Date last updated
30/05/2024
Titles & IDs
Public title
A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031)
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Scientific title
A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031)
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Secondary ID [1]
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2021-004727-33
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Secondary ID [2]
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CY 5032
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Universal Trial Number (UTN)
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Trial acronym
COURAGE OLE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Amyotrophic Lateral Sclerosis
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Condition category
Condition code
Neurological
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Neurodegenerative diseases
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Reldesemtiv
Experimental: Reldesemtiv 300 mg twice daily - Patients in this arm take 1 reldesemtiv 300 mg oral tablet twice a day for a 600 mg total daily dose (TDD)
Treatment: Drugs: Reldesemtiv
Oral tablet
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Long-term safety and tolerability of reldesemtiv in patients with ALS
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Assessment method [1]
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The incidence of adverse events (AEs) in the patient population
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Timepoint [1]
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Baseline to Week 48
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Secondary outcome [1]
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Long-term effect of reldesemtiv on ALSFRS-R functional outcomes and hospitalization by comparing early-start to delayed-start groups from CY 5031
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Assessment method [1]
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• Time to the first occurrence of respiratory insufficiency (defined as tracheostomy for any reason or the use of non-invasive ventilation (NIV) for =22 hours per day for =10 consecutive days) or death from date of randomization in CY 5031 through Week 48 of CY 5032
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Timepoint [1]
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Baseline to Week 48
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Secondary outcome [2]
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Long-term effect of reldesemtiv on ALSFRS-R functional outcomes and hospitalization by comparing early-start to delayed-start groups from CY 5031
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Assessment method [2]
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Time to the first hospitalization from Day 1 in CY 5031 through Week 48 of CY 5032
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Timepoint [2]
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Baseline to Week 48
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Secondary outcome [3]
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Long-term effect of reldesemtiv on ALSFRS-R functional outcomes and hospitalization by comparing early-start to delayed-start groups from CY 5031
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Assessment method [3]
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• Combined assessment of change in ALSFRS-R total score, time to onset of respiratory insufficiency, and survival time up to week 48. In this joint rank test each individual patient is ranked compared to all other patients based on survival time, time to onset of respiratory insufficiency, and changes from baseline to Week 24 in ALSFRS-R total score. Deaths have the worst rank (with earlier deaths being ranked worse than later deaths); patients with onset of respiratory insufficiency have the next worst rank; and the more favorable changes from baseline of CY 5031 through Week 48 of CY 5032 and from Week 24 of CY 5031 through Week 48 of CY 5032.
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Timepoint [3]
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Baseline to Week 48
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Secondary outcome [4]
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Long-term effect of reldesemtiv on ALSFRS-R functional outcomes and hospitalization by comparing early-start to delayed-start groups from CY 5031
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Assessment method [4]
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• Changes in ALS Functional Rating Scale -Revised (ALSFRS-R) total score from baseline of CY 5031 through Week 48 of CY 5032 and from Week 24 of CY 5031 through Week 48 of CY 5032
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Timepoint [4]
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Baseline to Week 48
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Secondary outcome [5]
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Long-term effect of reldesemtiv on ALSFRS-R functional outcomes and hospitalization by comparing early-start to delayed-start groups from CY 5031
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Assessment method [5]
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• Slopes of the changes in ALSFRS-R total score from baseline of CY 5031 through Week 48 of CY 5032 and from Week 24 of CY 5031 through Week 48 of CY 5032
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Timepoint [5]
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Baseline to Week 48
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Eligibility
Key inclusion criteria
- Able to comprehend and willing to sign an ICF and willing to comply with all study
procedures and restrictions for the duration specified in the Schedule of Activities.
If non-written consent is given, a Legal Designee of the patient must sign the ICF
form.
- Completed dosing in CY 5031
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Has taken investigational study drug (other than reldesemtiv) prior to dosing, within
30 days or five half-lives of the prior agent, whichever is greater
- Presence on Day 1 of any medically significant cardiac, pulmonary, gastrointestinal,
musculoskeletal, or psychiatric illness that might interfere with the patient's
ability to comply with study procedures or that might confound the interpretation of
clinical safety or efficacy data.
- Use of a strong cytochrome P450 (CYP) 3A4 inhibitor within 7 days prior to first dose
of reldesemtiv in CY 5032 or a strong CYP3A4 inducer within 14 days prior to first
dose of reldesemtiv in CY 5032
- Use of a medication that is an OCT1/OCT2 substrate within 7 days prior to first dose
of reldesemtiv in CY 5032
- Currently participating in another trial, managed access program, open label
extension, early access program, or through the right to try act is receiving an
investigational drug or received an investigational drug or device within 30 days (or
5 half-lives for drugs, whichever is longer) prior to Day 1. Patients also cannot be
taking outside of a clinical trial certain investigational drugs (which includes
drugs, supplements, and nutraceuticals) that are currently being studied or have been
studied for the treatment of ALS.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/07/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/06/2023
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Sample size
Target
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Accrual to date
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Final
72
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [2]
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Royal Brisbane and Women's Hospital, Neurology Department - Herston
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Recruitment hospital [3]
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The Perron Institute - Nedlands
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Arizona
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United States of America
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California
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Colorado
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District of Columbia
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Florida
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Indiana
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Kansas
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Maryland
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Michigan
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Nebraska
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New York
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North Carolina
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Ohio
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Wisconsin
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Belgium
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Leuven
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Alberta
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New Brunswick
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Dublin
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Torino
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Utrecht
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Madrid
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Spain
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Valencia
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Sweden
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Stockholm
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Cytokinetics
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the long-term safety and tolerability of reldesemtiv
in patients with ALS who have successfully completed dosing in the Phase 3 clinical trial, CY
5031 (also known as COURAGE-ALS)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05442775
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Cytokinetics MD
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Address
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Scientific Leadership at Cytokinetics
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05442775
Download to PDF