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

  • End date
    Feb 25, 2022
  • participants needed
  • sponsor
    Mitsubishi Tanabe Pharma America Inc.
Updated on 25 May 2021
Lia Tamburello, SC
Primary Contact
Atrium Health, Carolinas HealthCare System Neurosciences Institute (5.0 mi away) Contact
+42 other location


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.


Treatment will be prescribed by HCPs in accordance with their clinical judgement and the prescribing information for Edaravone. The decision to prescribe Edaravone to the participants should be made separately from the decision to enroll then in the study. There will be no randomized assignments to treatment and no restrictions on the use of commercially available medications (but those participating in an experimental study, even if taking Edaravone, will be excluded). No experimental treatment is evaluated in this study. The intervention is limited to the collection of blood and urine samples for biomarker testing.

During the estimated study period, eligible patients who are prescribed Edaravone within the approved indication will be invited to participate in the study. An initial screening/baseline visit will be scheduled for participants who are considered for study participation.

Participants in this study will be followed from enrollment up to 24 weeks after treatment initiation (6 treatment cycles [each cycle consisting of 28 days], corresponding to a treatment period of approximately 24 weeks) or premature study discontinuation. Throughout the study period, the investigators will record participant baseline and follow-up information and perform clinical and biomarker assessments.

Condition Myelopathy, Amyotrophic Lateral Sclerosis, Antilymphocyte Serum, Amyotrophic Lateral Sclerosis (ALS), Spinal Cord Disorders, lou gehrig's disease
Treatment Edaravone
Clinical Study IdentifierNCT04259255
SponsorMitsubishi Tanabe Pharma America Inc.
Last Modified on25 May 2021


Yes No Not Sure

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 nave 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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