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A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS)

The main purpose of this research study is to test whether an experimental drug called edaravone, is effective as treatment against ALS, and if it is safe and well tolerated when given to patients with your illness. The study will compare the efficacy and safety of an oral form of edaravone (a liquid solution that you will swallow) when given in 2 different ways.
Anne Haulman at ahaulman@pennstatehealth.psu.edu or 717-531-0003, ext=289123
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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04569084
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Inclusion Criteria:
Age 18-75
Diagnosed with amyotrophic lateral sclerosis (ALS)
Forced vital capacity (FVC) ≥ 70% predicted
Symptom onset within the past 2 years
Exclusion Criteria:
History of spinal surgery after the onset of ALS
Currently undergoing treatment for cancer
Hereditary fructose intolerance
Any previous treatment with edaravone
Neurology
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Location
Hershey, PA