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

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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

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.


Condition or disease Intervention/treatment
Amyotrophic Lateral Sclerosis Other: Sample Collection

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oxidative Markers and Efficacy in Amyotrophic Lateral Sclerosis (ALS) Phenotypes Treated With Edaravone
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021


Group/Cohort Intervention/treatment
Upper Motor Neuron predominant ALS Other: Sample Collection
We will be collecting blood, urine, and spinal fluid samples.

Lower Motor Neuron predominant ALS Other: Sample Collection
We will be collecting blood, urine, and spinal fluid samples.

Bulbar predominant ALS Other: Sample Collection
We will be collecting blood, urine, and spinal fluid samples.

Generalized ALS Other: Sample Collection
We will be collecting blood, urine, and spinal fluid samples.




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Blood Spinal Fluid Urine


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Anyone who meets the Inclusion/Exclusion Criteria
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097158


Contacts
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Contact: Imran Qasim (909) 558-2037 ext 25388 sqasim@llu.edu

Locations
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United States, California
Loma Linda University Not yet recruiting
Loma Linda, California, United States, 92354
Contact: Imran Qasim    909-558-2037 ext 25388    sqasim@llu.edu   
Principal Investigator: Jeffrey Rosenfeld, MD         
Sponsors and Collaborators
Loma Linda University
Temple University
Thomas Jefferson University
University of Southern California
Northwestern University
California Pacific Medical Center
Investigators
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Principal Investigator: Jeffrey Rosenfeld, PhD, MD Loma Linda University

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Responsible Party: Jeffrey Rosenfeld, Director, Neuromuscular ALS/MND Program, Loma Linda University
ClinicalTrials.gov Identifier: NCT04097158     History of Changes
Other Study ID Numbers: IRB#5190061
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Edaravone
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs