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A phase 3, multi-center, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of reldesemtiv in patients with amyotrophic lateral sclerosis (ALS)

The main purpose of this research study is to evaluate the efficacy and safety of reldesemtiv. By efficacy, we mean the effect of taking reldesemtiv and the participant's ability to perform certain functional assessments. By safety, we mean the collection of information about whether there are any negative symptoms and/or side effects that may result from taking reldesemtiv. Additionally, this research study will evaluate the pharmacokinetics (PK) of reldesemtiv (how much reldesemtiv gets into the blood stream and how long it takes the body to get rid of it).
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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04944784
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Inclusion Criteria:
Age 18-80
Diagnosed with amyotrophic lateral sclerosis (ALS)
First symptom of ALS within 24 months
Forced vital capacity (FVC) at least 65% predicted
Able to swallow whole tablets
Exclusion Criteria:
Tracheostomy
Other medical significant conditions that might interfere with your ability to participate
Neurology
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Location
Hershey, PA