Understanding how Edaravone works in different types of ALS patients
Oxidative Markers and Efficacy in Amyotrophic Lateral Sclerosis (ALS) Phenotypes Treated With Edaravone
This study is trying to see how the medication Edaravone affects different types of ALS patients and which ones might benefit the most from it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Loma Linda University Academic / other |
| Locations | 1 site (Loma Linda, California) |
| Trial ID | NCT04097158 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 85 with a diagnosis of ALS, regardless of cognitive involvement, who have not previously been treated with Edaravone.
Not a fit: Patients with unstable medical conditions or significant liver dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify which ALS patients are most likely to benefit from Edaravone, leading to more personalized treatment approaches.
How similar studies have performed: While there have been studies on Edaravone, this specific approach focusing on biomarkers in different ALS presentations is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Loma Linda, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.