300
Participants
Start Date
October 21, 2019
Primary Completion Date
March 31, 2024
Study Completion Date
March 31, 2024
Edaravone (Radicava®/Radicava ORS®)
"Participants will be followed from enrollment up to 24 weeks after treatment initiation (6 treatment cycles - 28 days per cycle, corresponding to a treatment period of approximately 24 weeks) or premature study discontinuation.~Biomarker testing and clinical assessments will be performed at baseline (at enrollment or before the start of cycle 1), and at cycles 1, 3, and 6. Dosing is 60 mg daily by intravenous infusion for 14 days for the initial treatment cycle, followed by daily dosing on 10 out of 14 days in subsequent treatment cycles."
Jefferson Weinberg ALS Center, Philadelphia
Temple University Lewis Katz School of Medicine, Philadelphia
Georgetown University Medical Center, Washington D.C.
Johns Hopkins University, Baltimore
University of Florida, Jacksonville -Neurology Research Department, Jacksonville
Mayo Clinic Florida, Jacksonville
University of South Florida, Tampa
OhioHealth, Columbus
Mercy Health, Grand Rapids
Medical College of Wisconsin, Milwaukee
Neurology Associates, P.C., Lincoln
University of Colorado, Denver
University of Utah, Salt Lake City
Barrow Neurological Institute, Phoenix
Las Vegas Clinic, Las Vegas
UCLA Als Clinic, Los Angeles
University of California, San Francisco, San Francisco
UC Davis Health, Sacramento
Massachusetts General Hospital, Boston
SunnyBrook Research Institute, Toronto
Lead Sponsor
Massachusetts General Hospital
OTHER
Mitsubishi Tanabe Pharma America Inc.
INDUSTRY