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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04097158

Enrollment

160

Registered

2019-09-20

Start date

2019-10-08

Completion date

2027-04-01

Last updated

2026-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Brief summary

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.

Interventions

OTHERSample Collection

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion 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

Exclusion criteria

1. Unstable medical illness 2. Abnormal liver function (\>2x ULN) 3. Unlikely to survive for 26 weeks

Design outcomes

Primary

Measure	Time frame	Description
Define pharmacodynamic biomarkers of oxidative stress and antioxidant capacity in different ALS/MND phenotypes.	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.

Countries

United States

Contacts

CONTACTImran Qasim

sqasim@llu.edu(909) 558-2037

PRINCIPAL_INVESTIGATORJeffrey Rosenfeld, PhD, MD

Loma Linda University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026