Understanding how Edaravone works in different types of ALS patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the effects of the FDA-approved medication Edaravone on various subsets of patients with Amyotrophic Lateral Sclerosis (ALS). The researchers will collect blood, urine, and spinal fluid samples from ALS patients who are both taking and not taking Edaravone to identify specific biomarkers that may indicate which patients benefit most from the treatment. The study will also explore the optimal duration of treatment for different forms of ALS. By analyzing these biomarkers, the study seeks to enhance understanding of ALS and improve patient care.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Jeffrey Rosenfeld, PhD, MD — Loma Linda University
• Study coordinator: Imran Qasim
• Email: sqasim@llu.edu
• Phone: (909) 558-2037

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.