Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)
Sponsor:
Brief Summary:
identify biomarkers to serve as quantifiable biological non-clinical measures of Edaravone
effects in ALS. Epigenetic and protein biomarkers will also be investigated.
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
Locations
- 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
