Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)

Completed

Conditions studied: Amyotrophic Lateral Sclerosis, ALS

In brief

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 facts

Study ID

NCT04259255

Run by

Shionogi

People needed

74

Starts

2019-10-21

Expected to finish

2024-11-24

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female aged 18 years or older at enrollment
• Sporadic or familial ALS diagnosed as possible, probable, probable-laboratory supported or definite as defined by the World Federation of Neurology revised El Escorial criteria
• Decision made to prescribe Edaravone prior to screening
• Participant will likely be able to obtain commercial Edaravone and likely to complete 6 cycles of treatment, per site investigator estimation
• Participant either naïve to Edaravone or who did not receive any Edaravone does within 1 month prior to screening
• Signed informed consent by the subject, or a witness if a subject cannot read or write or is physically unable to talk or write, obtained before any study-related activities are undertaken

You may not qualify if…

• Participant with a contraindication to Edaravone
• Participant is participating in an interventional clinical trial

Where it is running

• 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

Full record on ClinicalTrials.gov

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