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

This trial does not accept healthy volunteers

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 population

Anyone who meets the Inclusion/Exclusion Criteria

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Sample Collection

    Other intervention

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

Treatment groups

160 Participants
are divided into 4 treatment groups
Group A: Upper Motor Neuron predominant ALS1 intervention
Group B: Lower Motor Neuron predominant ALS1 intervention
Group C: Bulbar predominant ALS1 intervention
Group D: Generalized ALS1 intervention

Trial outcomes

Primary outcomes

1

Define pharmacodynamic biomarkers of oxidative stress and antioxidant capacity in different ALS/MND phenotypes.

The investigators aim to identify 4 cohorts of patients with distinct ALS/MND phenotypes and measure a panel of pharmacodynamic biomarkers of oxidative stress and antioxidant capacity in the CSF, blood, and urine.

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Loma Linda University

Lead sponsor

Temple University

Collaborator

Thomas Jefferson University

Collaborator

University of Southern California

Collaborator

Northwestern University

Collaborator