A Phase 3, Open-Label Extension of Reldesemtiv


About this study

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)

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

- Completed dosing in CY 5031.

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.

Eligibility last updated 7/6/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Bjorn Oskarsson, M.D.

Closed for enrollment

Contact information:

Colette McHugh Strong


More information


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