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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).
There will be a total of 16 visits over the course of 1 year. 7 of these visits will be in person in our clinic. At these visits, blood tests and breathing tests will be required.
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
Other medical significant conditions that might interfere with your ability to participate