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NCT04097158 · ClinicalTrials.gov registry record
Biomarkers in Different Types of Amyotrophic Lateral Sclerosis (ALS) Patients Being Treated With Edaravone
A clinical trial of Amyotrophic Lateral Sclerosis, sponsored by Loma Linda University.
- Recruiting
- Registry status
- 160
- Enrollment target
- 1
- Study location
NCT04097158: Recruiting study of Amyotrophic Lateral Sclerosis, sponsored by Loma Linda University.
NCT04097158 is a study of Amyotrophic Lateral Sclerosis that is actively recruiting participants, run by Loma Linda University. The registered enrollment target is 160 participants, below the 896-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04097158, a study of Amyotrophic Lateral Sclerosis, is actively recruiting participants, sponsored by Loma Linda University.
- RECRUITING
- Registry status
- 160 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Sample Collection
Study Locations (1)
California
- Loma Linda University - Loma Linda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2019-10-08 |
| Est. Completion | 2026-04 |
What NCT04097158 shows while recruiting
NCT04097158 is an observational study that tracks outcomes without assigning an intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 896-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Sample Collection is the first listed.
NCT04097158 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04097158 about?
NCT04097158 is a clinical study titled "Biomarkers in Different Types of Amyotrophic Lateral Sclerosis (ALS) Patients Being Treated With Edaravone". 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 ...
What is the current status of trial NCT04097158?
This trial is currently recruiting. The enrollment target is 160 participants. The study started on 2019-10-08. Estimated completion is 2026-04.
What conditions does trial NCT04097158 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis.
What interventions are being tested in trial NCT04097158?
The interventions under investigation include: Sample Collection (OTHER).
Who is sponsoring clinical trial NCT04097158?
This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04097158 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Amyotrophic Lateral Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04097158's enrollment target sits among peer trials
160 33rd of 102 higher than 69 of 102 other Amyotrophic Lateral Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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