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

Launched by LOMA LINDA UNIVERSITY · Sep 18, 2019

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called Edaravone (also known as Radicava) works in different types of patients with Amyotrophic Lateral Sclerosis (ALS). The researchers want to find out if certain groups of ALS patients, based on how their symptoms show up, might benefit more from this treatment. They are also looking at specific biological markers—substances in blood, urine, and spinal fluid—that may help determine how long patients should continue using Edaravone to get the best results.

To participate in this trial, individuals must be between 18 and 85 years old and have a confirmed diagnosis of ALS. They should not have taken Edaravone before, and they need to be on a stable dose of another ALS medication called Riluzole for at least 30 days. Participants will help researchers by providing samples of their blood, urine, and spinal fluid, which will be used to learn more about how Edaravone may help them and others with different forms of ALS. It's important to know that this trial is not providing the medication itself; Edaravone is already approved and prescribed as part of regular care for ALS.

Gender

ALL

Eligibility 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