RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-10-08
Study Completion:2025-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04097158

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Either possible, probable, or definite ALS, predominantly lower motor neuron disease, predominantly upper motor neuron disease, or bulbar
  2. 2. With or without cognitive involvement
  3. 3. Willing to participate
  4. 4. On no experimental treatment
  5. 5. Ages 18 - 85
  6. 6. No prior exposure to Edaravone (Radicava)
  7. 7. On a stable dose of Riluzole for 30 days or off Riluzole
  8. 8. Male or female
  9. 9. Females of childbearing age must use contraception
  1. 1. Unstable medical illness
  2. 2. Abnormal liver function (\>2x ULN)
  3. 3. Unlikely to survive for 26 weeks

Contacts and Locations

Study Contact

Imran Qasim
CONTACT
(909) 558-2037
sqasim@llu.edu

Principal Investigator

Jeffrey Rosenfeld, PhD, MD
PRINCIPAL_INVESTIGATOR
Loma Linda University

Study Locations (Sites)

Loma Linda University
Loma Linda, California, 92354
United States

Collaborators and Investigators

Sponsor: Loma Linda University

  • Jeffrey Rosenfeld, PhD, MD, PRINCIPAL_INVESTIGATOR, Loma Linda University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-10-08
Study Completion Date2025-04

Study Record Updates

Study Start Date2019-10-08
Study Completion Date2025-04

Terms related to this study

Additional Relevant MeSH Terms

  • Amyotrophic Lateral Sclerosis