RecruitingNCT04097158

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

Sponsor

Loma Linda University

Enrollment

160 participants

Start Date

Oct 8, 2019

Study Type

OBSERVATIONAL

Conditions

Amyotrophic Lateral Sclerosis

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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria9

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