A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031)

Study Purpose:

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)

Study Status:



Amyotrophic Lateral Sclerosis

Study Type:


Type of Intervention:


Intervention Name:





Phase 3

Study Chair(s)/Principal Investigator(s):

Cytokinetics MD, Scientific Leadership at Cytokinetics

Clinicaltrials.gov ID:


Neals Affiliated?


Coordinating Center Contact Information

Cytokinetics MD / email hidden; JavaScript is required / 650-624-2929

Full Study Summary:

CY 5032 is an open-label extension (OLE) study of the selective fast skeletal muscle troponin activator, reldesemtiv, in patients with ALS who finished dosing (through Week 48) in CY 5031 (COURAGE-ALS). Approximately 400 patients from the sites that participated in CY 5031 are expected to be enrolled in the open-label extension, CY 5032.

Following enrollment, patients will continue dosing with reldesemtiv, 300 mg twice a day for a 600 mg total daily dose (TDD) for a period of 48 weeks.

At the end of 48 weeks, patients may transition to a reldesemtiv Managed Access Program (MAP) the treating physician agrees to participate in the program.

Study Sponsor:


Estimated Enrollment:


Estimated Study Start Date:

07 / 25 / 2022

Estimated Study Completion Date:

12 / 01 / 2024

Posting Last Modified Date:

10 / 25 / 2022

Date Study Added to neals.org:

07 / 05 / 2022

Minimum Age:

18 Years

Maximum Age:


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

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.

California Pacific Medical Center | Recruiting

San Francisco, California 94109
United States

Mayo Clinic Jacksonville | Recruiting

Megan Donahue / email hidden; JavaScript is required

Jacksonville, Florida 32224
United States

The University of Kansas Medical Center | Recruiting

Kansas City, Kansas 66160
United States

Johns Hopkins Outpatient Center | Recruiting

Baltimore, Maryland 21287
United States

Neurology Associates | Recruiting

Lincoln, Nebraska 68506
United States

Atrium Health Neuroscience Institute | Recruiting

Charlotte, North Carolina 28207
United States

Virginia Commonwealth University | Recruiting

LaVon Smith / email hidden; JavaScript is required

Henrico, Virginia 23233
United States

University of Alberta | Recruiting

Kelsey Tymkow / email hidden; JavaScript is required

Edmonton, Alberta T6G1Z1

Stan Cassidy Centre for Rehabilitation | Recruiting

Colleen O'Connell

Shane McCullum / email hidden; JavaScript is required

Fredericton, New Brunswick E3B 0C7

McMaster University | Recruiting

Daniela Trapsa / email hidden; JavaScript is required

Hamilton, Ontario L8N4K1

Montreal Neurological Institute and Hospital | Recruiting

Montréal, Quebec H3A 2B4

University of Saskatchewan | Recruiting

Twyla Bode / email hidden; JavaScript is required

Saskatoon, Saskatchewan S7K0M7

CHU de Quebec-Universite Laval | Recruiting

Alexandra Simard / email hidden; JavaScript is required

Quebec G1J1Z4