Neurol Clin Pract 2021 Aug;11(4):e472-e479
Massachusetts General Hospital (JB), Boston; Atrium Health Neurosciences Institute (BB), Carolinas Medical Center, University of North Carolina School of Medicine-Charlotte Campus; Montreal Neurological Institute and Hospital (AG), QC, Canada; Lewis Katz School of Medicine (TH-P), Temple University, Philadelphia, PA; Houston Methodist (S. Appel), TX; University of Miami (MB), FL; Barrow Neurological Institute (RB, JS), Phoenix, AZ; Harvard Medical School (MC), Boston, MA; University of South Florida (CG), Tampa; Oxford BioDynamics Inc. (JW), Wilmington, DE; and Mitsubishi Tanabe Pharma America (WA, CM, SN, S. Apple), Inc., Jersey City, NJ.
Objectives: To identify putative biomarkers that may serve as quantifiable, biological, nonclinical measures of the pharmacodynamic effect of edaravone in amyotrophic lateral sclerosis (ALS) and to report real-world treatment outcomes.
Methods: This is a prospective, observational, longitudinal, multicenter (up to 40 sites) US study (Clinicaltrials.gov; NCT04259255) with at least 200 patients with ALS who will receive edaravone for 24 weeks (6 cycles; Food and Drug Administration-approved regimen). Read More