Actively Recruiting

Age: 18Years - 85Years
All Genders
NCT04097158

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

Led by Loma Linda University · Updated on 2025-05-21

160

Participants Needed

1

Research Sites

338 weeks

Total Duration

On this page

Sponsors

L

Loma Linda University

Lead Sponsor

T

Temple University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of possible, probable, or definite ALS, or predominantly lower motor neuron disease, predominantly upper motor neuron disease, or bulbar ALS
  • With or without cognitive involvement
  • Willing to participate in the study
  • Not receiving any experimental treatments
  • Age between 18 and 85 years
  • No prior use of Edaravone (Radicava)
  • On a stable dose of Riluzole for at least 30 days or not taking Riluzole
  • Male or female
  • Females of childbearing age must use contraception
Not Eligible

You will not qualify if you...

  • Having an unstable medical illness
  • Abnormal liver function greater than twice the upper limit of normal
  • Unlikely to survive for 26 weeks

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Loma Linda University

Loma Linda, California, United States, 92354

Actively Recruiting

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Research Team

I

Imran Qasim

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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