A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

The purpose of this study is to assess the effect of reldesemtiv versus placebo on functional outcomes in ALS.

Key facts

Study ID

NCT04944784

Run by

Cytokinetics

People needed

489

Starts

2021-08-16

Expected to finish

2023-07-18

Last updated by the study team

2024-12-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• eGFRCysC < 45.0 mL/min/1.73 m2 at screening
• Urine protein/creatinine ratio > 1 mg/mg (113 mg/mmol) at screening
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3-times the upper limit of normal (ULN)
• Total bilirubin (TBL), direct or indirect bilirubin above the ULN.
• Cognitive impairment, related to ALS or otherwise that impairs the patient's ability to understand and/or comply with study procedures and provide informed consent
• Other medically significant neurological conditions that could interfere with the assessment of ALS symptoms, signs or progression.
• Has a tracheostomy

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, 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
• Stanford Hospital and Clinics — Stanford, California, United States
• University of Colorado Hospital Anschutz Outpatient Pavilion — Aurora, Colorado, United States
• GW Medical Faculty Associates — Washington D.C., District of Columbia, United States
• University of Florida Jacksonville — Jacksonville, Florida, United States
• Mayo Clinic Florida — Jacksonville, Florida, United States
• University of South Florida - Carol and Frank Morsani Center for Advanced Health Care — Tampa, Florida, United States
• Duchossois Center for Advanced Medicine — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• The University of Kansas Medical Center — Kansas City, Kansas, United States
• Johns Hopkins Outpatient Center — Baltimore, Maryland, United States
• Massachusetts General Hospital - Neurological Clinical Research Institute — Boston, Massachusetts, United States
• University of Massachusetts Memorial Medical Center/Medical School — Worcester, Massachusetts, United States
• Michigan Medicine — Ann Arbor, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Washington University School of Medicine - Center for Advance Medicine — St Louis, Missouri, United States
• Neurology Associates, PC — Lincoln, Nebraska, United States
• Hospital for Special Surgery — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• St. Joseph's Hospital & Medical Center - Barrow Neurological Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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