Understanding Edaravone's Effects in ALS Patients
This observational study aims to better understand how the FDA-approved medication Edaravone (also known as Radicava) works in people with Amyotrophic Lateral Sclerosis (ALS). Researchers want to find out if certain types of ALS patients might benefit most from this medication and to determine the best treatment duration. You may be eligible if you are between 18 and 85 years old, have a diagnosis of ALS, are not on other experimental treatments, and have not previously taken Edaravone. The study will measure specific markers in your body (biomarkers) to understand how Edaravone affects oxidative stress and antioxidant capacity over 6 months. This study does not provide Edaravone; it is prescribed as part of your regular care.
- Study design
- This is an observational study planning to enroll 160 participants. It is not testing a new medication but rather observing the effects of an already approved drug.
- What's involved
- You would provide blood, urine, and spinal fluid samples. These samples will be collected to look for biomarkers related to oxidative stress and antioxidant capacity.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goal is to define biomarkers at 6 months, suggesting follow-up for at least this duration.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Biomarkers in Different Types of Amyotrophic Lateral Sclerosis (ALS) Patients Being Treated With Edaravone
At a glance
Conditions
NCT04097158
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Loma Linda University
Loma Linda, Californiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Jeffrey Rosenfeld, PhD, MD · PRINCIPAL_INVESTIGATOR · Loma Linda University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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.