Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04097158
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborators:
Temple University
Thomas Jefferson University
University of Southern California
Northwestern University
California Pacific Medical Center
Information provided by (Responsible Party):
Jeffrey Rosenfeld, Loma Linda University

Tracking Information
First Submitted Date September 18, 2019
First Posted Date September 20, 2019
Last Update Posted Date September 20, 2019
Estimated Study Start Date September 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 18, 2019)
Define pharmacodynamic biomarkers of oxidative stress and antioxidant capacity in different ALS/MND phenotypes. [ Time Frame: 6 months ]
We 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biomarkers in Different Types of Amyotrophic Lateral Sclerosis (ALS) Patients Being Treated With Edaravone
Official Title Oxidative Markers and Efficacy in Amyotrophic Lateral Sclerosis (ALS) Phenotypes Treated With Edaravone
Brief Summary

This study is being conducted to help us better understand how the new FDA approved medication Edaravone (also known as Radicava) works in subsets of patients with ALS. We are also trying to understand if there are specific ALS patients, with different presentations of ALS, who might benefit most from this medication. Also, we 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood Spinal Fluid Urine
Sampling Method Probability Sample
Study Population Anyone who meets the Inclusion/Exclusion Criteria
Condition Amyotrophic Lateral Sclerosis
Intervention Other: Sample Collection
We will be collecting blood, urine, and spinal fluid samples.
Study Groups/Cohorts
  • Upper Motor Neuron predominant ALS
    Intervention: Other: Sample Collection
  • Lower Motor Neuron predominant ALS
    Intervention: Other: Sample Collection
  • Bulbar predominant ALS
    Intervention: Other: Sample Collection
  • Generalized ALS
    Intervention: Other: Sample Collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: September 18, 2019)
160
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Imran Qasim (909) 558-2037 ext 25388 sqasim@llu.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04097158
Other Study ID Numbers IRB#5190061
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jeffrey Rosenfeld, Loma Linda University
Study Sponsor Loma Linda University
Collaborators
  • Temple University
  • Thomas Jefferson University
  • University of Southern California
  • Northwestern University
  • California Pacific Medical Center
Investigators
Principal Investigator: Jeffrey Rosenfeld, PhD, MD Loma Linda University
PRS Account Loma Linda University
Verification Date September 2019