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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorLoma Linda University

About this trial

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

Qualifiers

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

Disqualifiers

Unstable medical illness

Abnormal liver function (>2x ULN)

Unlikely to survive for 26 weeks

Trial design

Treatments tested in this trial

  • Sample Collection

Treatment groups

160 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Loma Linda University

Lead sponsor

Temple University

Collaborator

Thomas Jefferson University

Collaborator

University of Southern California

Collaborator

Northwestern University

Collaborator