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:

Not recruiting


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

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:

03 / 31 / 2023

Posting Last Modified Date:

04 / 14 / 2023

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.

St. Joseph's Hospital & Medical Center - Barrow Neurological Institute

Phoenix, Arizona 85013
United States

University of California Irvine - ALS & Neuromuscular Center

Orange, California 92868
United States

California Pacific Medical Center - Forbes Norris MDA/ALS Research Center

San Francisco, California 94109
United States

University of Colorado Hospital Anschutz Outpatient Pavilion

Aurora, Colorado 80045
United States

George Washington Medical Faculty Associates

Washington, District of Columbia 20037
United States

University of Florida

Jacksonville, Florida 32209
United States

Mayo Clinic Jacksonville

Jacksonville, Florida 32224
United States

University of South Florida - Carol and Frank Morsani Center for Advanced Health Care

Tampa, Florida 33612
United States

Indiana University IU Health Neuroscience Center

Indianapolis, Indiana 43202
United States

The University of Kansas Medical Center

Kansas City, Kansas 66160
United States

Johns Hopkins Outpatient Center

Baltimore, Maryland 21287
United States

Michigan Medicine

Ann Arbor, Michigan 48109
United States

Henry Ford Hospital

Detroit, Michigan 48202
United States

Neurology Associates

Lincoln, Nebraska 68506
United States

Hospital for Special Surgery

New York, New York 10021
United States

SUNY Upstate Medical University Institute for Human Performance

Syracuse, New York 13210
United States

Atrium Health Neuroscience Institute

Charlotte, North Carolina 28207
United States

Cleveland Clinic

Cleveland, Ohio 44195
United States

Texas Neurology, P.A.

Dallas, Texas 75206
United States

Virginia Commonwealth University

Henrico, Virginia 23233
United States

Froedtert Hospital - Department of Neurology

Milwaukee, Wisconsin 53226
United States

Concord Repatriation General Hospital

Concord, New South Wales 2139

The Perron Institute

Nedlands 6009

Royal Brisbane and Women's Hospital, Neurology Department

Herston, Queensland 4029

Uz Leuven Gasthuisberg Department of Neurology

Leuven 3000

Sunnybrook Health Sciences Centre

Toronto, Ontario M4N 3M5

CHU de Quebec-Universite Laval

Quebec G1J1Z4

University of Saskatchewan

Saskatoon, Saskatchewan S7K0M7

Montreal Neurological Institute and Hospital

Montréal, Quebec H3A 2B4

Ottawa Hospital Research Institute

Ottawa, Ontario K1Y4E9

McMaster University

Hamilton, Ontario L8N4K1

Stan Cassidy Centre for Rehabilitation

Fredericton, New Brunswick E3B 0C7

University of Alberta

Edmonton, Alberta T6G1Z1

University of Calgary - Heritage Medical Research Clinic

Calgary, Alberta T2N 4Z6

RSCI Education and Research Center Beaumount Hospital

Dublin 9

IRCCS Istituto Auxologico Italiano Ospedale San Luca U.O. Neurologia e Stroke Unit

Milan 20149

AOU Citta della Salute e della Scienza di Torino Universita degli Studi di Torino P.O. Mollinette - Dipartimento de Neuroscienze "Rita Levi Montalcini"

Torino 10126

UMC Utrecht Department of Neurology, ALS Center

Utrecht 3584

Hospital San Rafael

Madrid 28016

Hospital Universitario y Politecnico La Fe

Valencia 46026

Studieenheten, Akademiskt Specialistcentrum

Stockholm 113 61