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Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)
Sponsor: Shionogi
Summary
REFINE-ALS is a prospective, observational, longitudinal, multicenter study designed to identify biomarkers to serve as quantifiable biological non-clinical measures of Edaravone effects in ALS. Epigenetic and protein biomarkers will also be investigated.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
74
Start Date
2019-10-21
Completion Date
2024-11-24
Last Updated
2026-06-30
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (20)
Barrow Neurological Institute
Phoenix, Arizona, United States
UCLA Als Clinic
Los Angeles, California, United States
UC Davis Health
Sacramento, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado
Denver, Colorado, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
University of Florida, Jacksonville -Neurology Research Department
Jacksonville, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mercy Health
Grand Rapids, Michigan, United States
Neurology Associates, P.C.
Lincoln, Nebraska, United States
Las Vegas Clinic
Las Vegas, Nevada, United States
OhioHealth
Columbus, Ohio, United States
Jefferson Weinberg ALS Center
Philadelphia, Pennsylvania, United States
Temple University Lewis Katz School of Medicine
Philadelphia, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
SunnyBrook Research Institute
Toronto, Ontario, Canada