Biomarkers in Different Types of Amyotrophic Lateral Sclerosis (ALS) Patients Being Treated With Edaravone
NCT ID: NCT04097158
Last Updated: 2025-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
160 participants
OBSERVATIONAL
2019-10-08
2026-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Upper Motor Neuron predominant ALS
Sample Collection
The investigators will be collecting blood, urine, and spinal fluid samples.
Lower Motor Neuron predominant ALS
Sample Collection
The investigators will be collecting blood, urine, and spinal fluid samples.
Bulbar predominant ALS
Sample Collection
The investigators will be collecting blood, urine, and spinal fluid samples.
Generalized ALS
Sample Collection
The investigators will be collecting blood, urine, and spinal fluid samples.
Interventions
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Sample Collection
The investigators will be collecting blood, urine, and spinal fluid samples.
Eligibility Criteria
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Inclusion Criteria
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
2. Abnormal liver function (\>2x ULN)
3. Unlikely to survive for 26 weeks
18 Years
85 Years
ALL
No
Sponsors
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Temple University
OTHER
Thomas Jefferson University
OTHER
University of Southern California
OTHER
Northwestern University
OTHER
Loma Linda University
OTHER
Responsible Party
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Principal Investigators
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Jeffrey Rosenfeld, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Loma Linda University
Locations
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Loma Linda University
Loma Linda, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB#5190061
Identifier Type: -
Identifier Source: org_study_id
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