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

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 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.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Observational Study

Study Category:

Biomarkers/Imaging

Study Status:

Enrolling

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Jeffrey Rosenfeld, PhD, MD Loma Linda University

Clinicaltrials.gov ID (11 digit #):

NCT04097158

Neals Affiliated?

No

Coordinating Center Contact Information

Loma Linda University
Imran Qasim / .(JavaScript must be enabled to view this email address) / 909-558-2037 ext 25388
.(JavaScript must be enabled to view this email address) Loma Linda, California 92354 United States

Full Study Summary:

Study Sponsor:

Loma Linda University

Participant Duration:

Estimated Enrollment:

160

Estimated Study Start Date:

10/08/2019

Estimated Study Completion Date:

09/30/2021

Posting Last Modified Date:

02/24/2020

Date Study Added to alsconsortium.org:

02/24/2020
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    85

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    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

  • Site Contact Information

    Loma Linda University
    Imran Qasim / .(JavaScript must be enabled to view this email address) / 909-558-2037 ext 25388
    Loma Linda, California 92354
    United States