NCT04259255Completed
Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 74 (actual)
- First submitted
- 27 Jan 2020
- Start date
- 21 Oct 2019
- Primary completion date
- 24 Nov 2023
- Lead sponsor
- Shionogi
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT04259255
What you commit to
- Study type: Observational
- Participants enrolled: 74
- From 21 Oct 2019 to the primary completion date, 24 Nov 2023
- 20 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Participant with a contraindication to Edaravone
- Participant is participating in an interventional clinical trial
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunnybrook Research Institute Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| OhioHealth Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| University of Colorado Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Mercy Health Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| University of Florida, Jacksonville -Neurology Research Department Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Mayo Clinic Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Las Vegas Clinic Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Neurology Associates, P.C. Coordinator of this site? Confirm its status | Lincoln | United States | Unknown status |
| UCLA Als Clinic Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Jefferson Weinberg ALS Center Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Temple University Lewis Katz School of Medicine Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Barrow Neurological Institute Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| UC Davis Health Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Georgetown University Medical Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.