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

Stopped early · Phase 3

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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)

Key facts

Study ID

NCT05442775

Run by

Cytokinetics

People needed

71

Starts

2022-08-04

Expected to finish

2023-06-07

Last updated by the study team

2024-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• St. Joseph's Hospital & Medical Center - Barrow Neurological Institute — Phoenix, Arizona, United States
• University of California Irvine - ALS & Neuromuscular Center — Orange, California, United States
• California Pacific Medical Center - Forbes Norris MDA/ALS Research Center — San Francisco, California, United States
• University of Colorado Hospital Anschutz Outpatient Pavilion — Aurora, Colorado, United States
• George Washington Medical Faculty Associates — Washington D.C., District of Columbia, United States
• University of Florida — Jacksonville, Florida, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• University of South Florida - Carol and Frank Morsani Center for Advanced Health Care — Tampa, Florida, United States
• Indiana University IU Health Neuroscience Center — Indianapolis, Indiana, United States
• The University of Kansas Medical Center — Kansas City, Kansas, United States
• Johns Hopkins Outpatient Center — Baltimore, Maryland, United States
• Michigan Medicine — Ann Arbor, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Neurology Associates — Lincoln, Nebraska, United States
• Hospital for Special Surgery — New York, New York, United States
• SUNY Upstate Medical University Institute for Human Performance — Syracuse, New York, United States
• Atrium Health Neuroscience Institute — Charlotte, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Texas Neurology, P.A. — Dallas, Texas, United States
• Virginia Commonwealth University — Henrico, Virginia, United States
• Froedtert Hospital - Department of Neurology — Milwaukee, Wisconsin, United States
• Concord Repatriation General Hospital — Concord, New South Wales, Australia
• Royal Brisbane and Women's Hospital, Neurology Department — Herston, Queensland, Australia
• The Perron Institute — Nedlands, Australia
• Uz Leuven Gasthuisberg Department of Neurology — Leuven, Belgium

Full record on ClinicalTrials.gov

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