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NCT Number: NCT04097158

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

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Loma Linda University

Loma Linda, California, 92354, United States

Location status: Recruiting

Location contact

Imran Qasim

CONTACT

[email protected]

909-558-2037 ext. 25388

Jeffrey Rosenfeld, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Either possible, probable, or definite ALS, predominantly lower motor neuron disease, predominantly upper motor neuron disease, or bulbar
  • With or without cognitive involvement
  • Willing to participate
  • On no experimental treatment
  • Ages 18 - 85
  • No prior exposure to Edaravone (Radicava)
  • On a stable dose of Riluzole for 30 days or off Riluzole
  • Male or female
  • Females of childbearing age must use contraception

Exclusion criteria

  • Unstable medical illness
  • Abnormal liver function (>2x ULN)
  • Unlikely to survive for 26 weeks

Treatment and study plan

Sample collection

Other

The investigators will be collecting blood, urine, and spinal fluid samples.

Primary outcomes

  1. Define pharmacodynamic biomarkers of oxidative stress and antioxidant capacity in different ALS/MND phenotypes.

    Time frame: 6 months

    The investigators aim to identify 4 cohorts of patients with distinct ALS/MND phenotypes and measure a panel of pharmacodynamic biomarkers of oxidative stress and antioxidant capacity in the CSF, blood, and urine.

Study contacts

Contact information is provided by the study sponsor or research team.

Imran Qasim

CONTACT

[email protected]

(909) 558-2037 ext. 25388

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Collaborators

  • Northwestern University
  • Temple University
  • Thomas Jefferson University
  • University of Southern California

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Sep 20, 2019
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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