Oxidative Markers and Efficacy in Amyotrophic Lateral Sclerosis (ALS) Phenotypes Treated With Edaravone

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Loma Linda University
RECRUITING
Loma Linda
Contact Information
Primary
Imran Qasim
sqasim@llu.edu
(909) 558-2037
Time Frame
Start Date: 2019-10-08
Estimated Completion Date: 2026-04
Participants
Target number of participants: 160
Treatments
Upper Motor Neuron predominant ALS
Lower Motor Neuron predominant ALS
Bulbar predominant ALS
Generalized ALS
Sponsors
Collaborators: University of Southern California, Northwestern University, Temple University, Thomas Jefferson University
Leads: Loma Linda University

This content was sourced from clinicaltrials.gov