Radicava® (Edaravone) Biomarker Study in Participants with Amyotrophic Lateral Sclerosis

Overview

About this study

The clinical development program has demonstrated that Edaravone is a well-tolerated treatment that slows the loss of physical function in ALS.
However, as observed in prior clinical trials, ALS presentation and progression is extremely heterogeneous among patients. There is therefore an imperious need for biomarkers, which could act as reliable indicators for Edaravone’s effect on disease progression and help better elucidate Edaravone’s mechanism of action. Biomarkers can help explain empirical results of clinical outcomes by helping us understand the mechanistic molecular and cellular pathways to clinical response. Future applications of biomarker identification will include determining the feasibility and face validity of these biomarkers in a patient registry study conducted in patients going on Edaravone as part of their clinical treatment plan, incorporating identified biomarkers in a large controlled post-marketing commitment study required by FDA studying higher and more frequent dosing of intravenous Edaravone in ALS compared to usual dosing, and optimizing development and dosing scheme for non-intravenous Edaravone formulation.
The present protocol is designed to investigate a selected panel of biomarkers in patients with ALS, treated with Edaravone. Biomarkers of oxidative stress, inflammation and neurodegeneration will be explored. Epigenetic and protein biomarkers will also be investigated.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 dose 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Bjorn Oskarsson, M.D.

Open for enrollment

Contact information:

Lisa Thuro

Thuro.Lisa@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20492623

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