Open Actively Recruiting

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

About

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.

Study Type
Observational

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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

Join this Trial

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Study Stats
Protocol No.
19-001756
Category
Neurology
Urology
Principal Investigator
MARTINA WIEDAU-PAZOS
Contact
SUCHI TIWARI
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04259255
For detailed technical eligibility, visit ClinicalTrials.gov.