Status:
RECRUITING
Biomarkers in Different Types of Amyotrophic Lateral Sclerosis (ALS) Patients Being Treated With Edaravone
Lead Sponsor:
Loma Linda University
Collaborating Sponsors:
Temple University
Thomas Jefferson University
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-85 years
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 investigator...
Eligibility Criteria
Inclusion
- 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
- Unstable medical illness
- Abnormal liver function (\>2x ULN)
- Unlikely to survive for 26 weeks
Key Trial Info
Start Date :
October 8 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04097158
Start Date
October 8 2019
End Date
April 1 2026
Last Update
May 21 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Loma Linda University
Loma Linda, California, United States, 92354