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


Brief 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.


Inclusion Criteria:

– 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

Exclusion Criteria:

– Participant with a contraindication to Edaravone

– Participant is participating in an interventional clinical trial


  • UCLA Als Clinic, Los Angeles, California, United States, 90024
  • VA GLA ALS Multidisciplinary Clinic, Los Angeles, California, United States, 90073
  • UC Irvine, Orange, California, United States, 92868
  • UC Davis Health, Sacramento, California, United States, 95817
  • Forbes Norris MDA/ALS Research Center, San Francisco, California, United States, 94109
  • University of California, San Francisco, San Francisco, California, United States, 94417
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