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

Sponsor:

Brief 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.

Criteria

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

Locations

  • Loma Linda University, Loma Linda, California, United States, 92354
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