What this study is
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.
What's being tested
- Sample Collection
Intervention · OTHER
The investigators will be collecting blood, urine, and spinal fluid samples.
Study details
- Official title
- Oxidative Markers and Efficacy in Amyotrophic Lateral Sclerosis (ALS) Phenotypes Treated With Edaravone
- Sponsor
- Loma Linda University
- Conditions
- Amyotrophic Lateral Sclerosis
- Enrolling
- 160 people
- Starts
- 2019-10-08
- Est. completion
- 2027-04
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 85 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- Unstable medical illness
- Abnormal liver function (>2x ULN)
- Unlikely to survive for 26 weeks
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openLoma Linda University
Loma Linda, California, United States
- Imran Qasim · Contact909-558-2037 ext. 25388sqasim@llu.edu
- Jeffrey Rosenfeld, MD · Principal investigator
Recruiting
Study team
Sponsor
Loma Linda University
Study ID IRB#5190061
Principal investigator
Jeffrey Rosenfeld, PhD, MD
Loma Linda University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.