Recruiting

Edaravone

Sponsor:

Loma Linda University

Code:

NCT04097158

Conditions

Amyotrophic Lateral Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Sample Collection

Study Details

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.

Conditions

Amyotrophic Lateral Sclerosis

Study ID

NCT04097158

Start date

Oct 8, 2019

Status verified date

Jun, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Arms

Upper Motor Neuron predominant ALS

Lower Motor Neuron predominant ALS

Bulbar predominant ALS

Generalized ALS

Interventions

Sample Collection

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

Primary outcome measure

  • Define pharmacodynamic biomarkers of oxidative stress and antioxidant capacity in different ALS/MND phenotypes. [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Imran Qasim

(909) 558-2037sqasim@llu.edu

Locations

Loma Linda University

Recruiting

Loma Linda, California, United States, 92354

Contacts

Imran Qasim

909-558-2037sqasim@llu.edu

Principal Investigator:

Jeffrey Rosenfeld, MD

More Information

Sponsor

Loma Linda University

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Loma Linda University on 2026-06-05.