Biomarkers in Different Types of Amyotrophic Lateral Sclerosis (ALS) Patients Being Treated With Edaravone

Sponsor

Loma Linda University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04097158

Collaborator

Temple University (Other), Thomas Jefferson University (Other), University of Southern California (Other), Northwestern University (Other)

160

Enrollment

Location

46.8

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Amyotrophic Lateral Sclerosis	Other: Sample Collection

Study Design

Study Type:

Observational

Anticipated Enrollment :

160 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 8, 2019

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Upper Motor Neuron predominant ALS	Other: Sample Collection The investigators will be collecting blood, urine, and spinal fluid samples.
Lower Motor Neuron predominant ALS	Other: Sample Collection The investigators will be collecting blood, urine, and spinal fluid samples.
Bulbar predominant ALS	Other: Sample Collection The investigators will be collecting blood, urine, and spinal fluid samples.
Generalized ALS	Other: Sample Collection The investigators will be collecting blood, urine, and spinal fluid samples.

Outcome Measures

Primary Outcome Measures

Define pharmacodynamic biomarkers of oxidative stress and antioxidant capacity in different ALS/MND phenotypes. [6 months]
The investigators aim to identify 4 cohorts of patients with distinct ALS/MND phenotypes and measure a panel of pharmacodynamic biomarkers of oxidative stress and antioxidant capacity in the CSF, blood, and urine.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

Unstable medical illness
Abnormal liver function (>2x ULN)
Unlikely to survive for 26 weeks

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loma Linda University	Loma Linda	California	United States	92354

Sponsors and Collaborators

Loma Linda University
Temple University
Thomas Jefferson University
University of Southern California
Northwestern University

Investigators

Principal Investigator: Jeffrey Rosenfeld, PhD, MD, Loma Linda University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Loma Linda University

ClinicalTrials.gov Identifier:

NCT04097158

Other Study ID Numbers:

IRB#5190061

First Posted:

Sep 20, 2019

Last Update Posted:

Jan 18, 2022

Last Verified:

Jan 1, 2022

Additional relevant MeSH terms:

Motor Neuron Disease

Amyotrophic Lateral Sclerosis

Sclerosis

Study Results

No Results Posted as of Jan 18, 2022