NCT04097158Recruiting
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
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 160 (estimated)
- First submitted
- 18 Sept 2019
- Start date
- 8 Oct 2019
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Loma Linda University
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT04097158
What you commit to
- Study type: Observational
- Planned participants: 160
- From 8 Oct 2019 to the primary completion date, 30 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Unstable medical illness
Lab values
- Abnormal liver function (\>2x ULN)
Other
- Unlikely to survive for 26 weeks
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Loma Linda University Coordinator of this site? Confirm its status | Loma Linda | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.