Trial Review

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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)
Scientific title
A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031)
Secondary ID [1] 0 0
2021-004727-33
Secondary ID [2] 0 0
CY 5032
Universal Trial Number (UTN)
Trial acronym
COURAGE OLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Amyotrophic Lateral Sclerosis 0 0
Condition category
Condition code
Neurological 0 0 0 0
Neurodegenerative diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Long-term safety and tolerability of reldesemtiv in patients with ALS
Timepoint [1] 0 0
Baseline to Week 48
Secondary outcome [1] 0 0
Long-term effect of reldesemtiv on ALSFRS-R functional outcomes and hospitalization by comparing early-start to delayed-start groups from CY 5031
Timepoint [1] 0 0
Baseline to Week 48
Secondary outcome [2] 0 0
Long-term effect of reldesemtiv on ALSFRS-R functional outcomes and hospitalization by comparing early-start to delayed-start groups from CY 5031
Timepoint [2] 0 0
Baseline to Week 48
Secondary outcome [3] 0 0
Long-term effect of reldesemtiv on ALSFRS-R functional outcomes and hospitalization by comparing early-start to delayed-start groups from CY 5031
Timepoint [3] 0 0
Baseline to Week 48
Secondary outcome [4] 0 0
Long-term effect of reldesemtiv on ALSFRS-R functional outcomes and hospitalization by comparing early-start to delayed-start groups from CY 5031
Timepoint [4] 0 0
Baseline to Week 48
Secondary outcome [5] 0 0
Long-term effect of reldesemtiv on ALSFRS-R functional outcomes and hospitalization by comparing early-start to delayed-start groups from CY 5031
Timepoint [5] 0 0
Baseline to Week 48

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/06/2023
Sample size
Target
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital, Neurology Department - Herston
Recruitment hospital [3] 0 0
The Perron Institute - Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
United States of America
State/province [16] 0 0
Wisconsin
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
New Brunswick
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Canada
State/province [22] 0 0
Saskatchewan
Country [23] 0 0
Ireland
State/province [23] 0 0
Dublin
Country [24] 0 0
Italy
State/province [24] 0 0
Milan
Country [25] 0 0
Italy
State/province [25] 0 0
Torino
Country [26] 0 0
Netherlands
State/province [26] 0 0
Utrecht
Country [27] 0 0
Spain
State/province [27] 0 0
Madrid
Country [28] 0 0
Spain
State/province [28] 0 0
Valencia
Country [29] 0 0
Sweden
State/province [29] 0 0
Stockholm

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cytokinetics
Address
Country

Ethics approval
Ethics application status

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)
Trial website
https://clinicaltrials.gov/ct2/show/NCT05442775
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Cytokinetics MD
Address 0 0
Scientific Leadership at Cytokinetics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05442775