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

Study Overview
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Brief Summary
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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.

Official Title
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Oxidative Markers and Efficacy in Amyotrophic Lateral Sclerosis (ALS) Phenotypes Treated With Edaravone

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Other: Sample Collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Unstable medical illness Abnormal liver function (>2x ULN) Unlikely to survive for 26 weeks

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Upper Motor Neuron predominant ALS<br> | Other: Sample Collection<br>* The investigators will be collecting blood, urine, and spinal fluid samples.<br>|
| Lower Motor Neuron predominant ALS<br> | Other: Sample Collection<br>* The investigators will be collecting blood, urine, and spinal fluid samples.<br>|
| Bulbar predominant ALS<br> | Other: Sample Collection<br>* The investigators will be collecting blood, urine, and spinal fluid samples.<br>|
| Generalized ALS<br> | Other: Sample Collection<br>* The investigators will be collecting blood, urine, and spinal fluid samples.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months |