Study Purpose:
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 ALSThere 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.
Study Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Observational
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Jeffrey Rosenfeld, PhD, MD, Loma Linda University
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Loma Linda University
Imran Qasim / email hidden; JavaScript is required / (909) 558-2037
Loma Linda, California, 92354 United States
Study Sponsor:
Loma Linda University
Estimated Enrollment:
160
Estimated Study Start Date:
10 / 08 / 2019
Estimated Study Completion Date:
09 / 01 / 2023
Posting Last Modified Date:
01 / 18 / 2022
Date Study Added to neals.org:
09 / 20 / 2019
Minimum Age:
18 Years
Maximum Age:
85 Years
Can participants use Riluzole?
Yes
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
Loma Linda University | Recruiting
Imran Qasim / 909-558-2037 Ext. 25388 / email hidden; JavaScript is required
Principal Investigator : Jeffrey Rosenfeld, MD
Loma Linda, California
92354
United States