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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04097158
• Other study ID #: IRB#5190061
• Status: Recruiting
• Start date: October 8, 2019
• Est. completion date: September 2024

Study information

• Verified date: December 2023
• Source: Loma Linda University
• Contact: Imran Qasim
• Phone: (909) 558-2037
• Email: sqasim[@]llu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Other:
• Sample Collection
The investigators will be collecting blood, urine, and spinal fluid samples.

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (5)

Lead Sponsor	Collaborator
Loma Linda University	Northwestern University, Temple University, Thomas Jefferson University, University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Define pharmacodynamic biomarkers of oxidative stress and antioxidant capacity in different ALS/MND phenotypes.	The investigators 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.	6 months