Cytokinetics CY 5031 - COURAGE-ALS

Condition: Amyotrophic lateral sclerosis

Eligibility

Key Inclusion Criteria:

  • 18-80 years old
  • Diagnosis of familial or sporadic amyotrophic lateral sclerosis (ALS)
  • First symptom of ALS ≤24 months prior to screening

Key Exclusion Criteria:

  • Cognitive impairment, related to ALS or otherwise, that impairs ability to understand
    and/or comply with study procedures and provide informed consent
  • Presence at screening of any medically significant cardiac, pulmonary, gastrointestinal, musculoskeletal, or psychiatric illness that might interfere with the ability to comply with study procedures or that might confound research data
  • Has a tracheostomy

Study Name

A Phase III, Multicenter, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS) (IRB no. 00001329)

Summary

The purpose of this study is to evaluate the effectiveness and safety of an investigational drug called reldesemtiv in amyotrophic lateral sclerosis (ALS). The study will evaluate patients’ muscle strength and breathing, as well as conduct physical assessments and questionnaires. The questionnaires will address quality of life, mood, and ALS function. Blood and urine samples will also be collected. Additionally, researchers will evaluate the pharmacokinetics of reldesemtiv (how much reldesemtiv gets into the blood stream and how long it takes the body to get rid of it).

Reldesemtiv is being studied as a potential new therapy for the improvement of skeletal muscle function in conditions associated with muscle weakness or fatigue, such as ALS. Participants will be randomly assigned to receive either reldesemtiv or placebo (inactive substance).

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