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A clinical study starting in late 2019 will identify and measure biomarkers in patients with amyotrophic lateral sclerosis (ALS) and evaluate the treatment effect of edaravone (Radicava; Mitsubishi Tanabe Pharma America, Jersey City, NJ).
In the planned 24-week, prospective, observational trial, 200 patients will complete 6 cycles (24 weeks) of treatment with edaravone. Researchers will evaluate oxidative stress, inflammation, neuronal injury and death, and muscle injury. Biomarker and clinical assessments will be obtained prior to initiating edaravone, at the start of treatment, and at pre-specified points throughout the study.
"This study will broaden our understanding of numerous biomarkers that may be associated with ALS, including those for oxidative stress, inflammation, muscle and neuronal injury and death,” said James Berry, MD, MPH, Massachusetts General Hospital, Boston, MA. “It will increase our understanding of ALS and of the biological effects of edaravone in people with ALS undergoing therapy."
Jennifer Medina, PhD; and Sarah J. Banks, PhD, ABPP-CN
Jeffrey L. Cummings, MD, ScD
Serge Gauthier, CM, CQ, MD, FRCPC; and Pedro Rosa-Neto, MD, PhD