Biomarkers in Different Types of Amyotrophic Lateral Sclerosis (ALS) Patients Being Treated With Edaravone

Description

This study is being conducted to help the investigators better understand how the new FDA approved medication Edaravone (also known as Radicava) works in subsets of patients with ALS. The investigators are also trying to understand if there are specific ALS patients, with different presentations of ALS, who might benefit most from this medication. Also, the investigators are following specific biomarkers to determine the optimal treatment duration in patients with different forms of ALS There is no study medication being offered in this trial. Edaravone is prescribed as part of regular care. In this trial we are collecting blood, urine, and spinal fluid samples in ALS patients who are taking Edaravone and ALS patients who are not taking Edaravone to measure certain markers that could indicate why the drug may be working in a specific type of ALS.

Conditions

Amyotrophic Lateral Sclerosis

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Study Overview

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Study Details

Study overview

This study is being conducted to help the investigators better understand how the new FDA approved medication Edaravone (also known as Radicava) works in subsets of patients with ALS. The investigators are also trying to understand if there are specific ALS patients, with different presentations of ALS, who might benefit most from this medication. Also, the investigators are following specific biomarkers to determine the optimal treatment duration in patients with different forms of ALS There is no study medication being offered in this trial. Edaravone is prescribed as part of regular care. In this trial we are collecting blood, urine, and spinal fluid samples in ALS patients who are taking Edaravone and ALS patients who are not taking Edaravone to measure certain markers that could indicate why the drug may be working in a specific type of ALS.

Oxidative Markers and Efficacy in Amyotrophic Lateral Sclerosis (ALS) Phenotypes Treated With Edaravone

Biomarkers in Different Types of Amyotrophic Lateral Sclerosis (ALS) Patients Being Treated With Edaravone

Condition
Amyotrophic Lateral Sclerosis
Intervention / Treatment

-

Contacts and Locations

Loma Linda

Loma Linda University, Loma Linda, California, United States, 92354

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Either possible, probable, or definite ALS, predominantly lower motor neuron disease, predominantly upper motor neuron disease, or bulbar
  • 2. With or without cognitive involvement
  • 3. Willing to participate
  • 4. On no experimental treatment
  • 5. Ages 18 - 85
  • 6. No prior exposure to Edaravone (Radicava)
  • 7. On a stable dose of Riluzole for 30 days or off Riluzole
  • 8. Male or female
  • 9. Females of childbearing age must use contraception
  • 1. Unstable medical illness
  • 2. Abnormal liver function (\>2x ULN)
  • 3. Unlikely to survive for 26 weeks

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Loma Linda University,

Jeffrey Rosenfeld, PhD, MD, PRINCIPAL_INVESTIGATOR, Loma Linda University

Study Record Dates

2025-04