Back to Trials
NCT04097158Recruiting

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

Loma Linda University

Start Date

10/8/2019

Completion Date

4/1/2027

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.

Eligibility Criteria

Age Range: 18 years to 85 years

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

Interventions

OTHER

Sample Collection

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Amyotrophic Lateral Sclerosis

Locations

Loma Linda University

Loma Linda, California 92354

United States