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Could everyday antioxidants be a weapon against ALS?

NCT ID NCT04244630

Disease control Sponsor: Dallas VA Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This Phase 2 trial tests whether a combination of over-the-counter antioxidants, including vitamin E and N-acetylcysteine, can slow the progression of amyotrophic lateral sclerosis (ALS). Researchers will give high doses of these supplements to 21 adults with ALS and measure changes in a blood marker of nerve damage and functional decline over 12 months. The goal is to validate earlier findings that suggested antioxidants might help, offering a simple and low-cost approach to a disease with no effective treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A combination of over-the-counter antioxidants: vitamin E, N-acetylcysteine, L-cystine, nicotinamide, and taurursodiol
What this could lead to
If it works, this could point toward a simple, low-cost way to slow or stop ALS progression, a disease with no effective treatment.
What could go wrong
This is a small Phase 2 trial with 21 participants, so results may not apply broadly. The supplements are considered safe, but their effect on ALS is unproven and may not match earlier findings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

21 people

The number who actually took part.

Started

Nov 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. A clinical diagnosis by a study investigator of laboratory-supported probable, probable, or definite ALS, according to a modified El Escorial criterion (Appendix 2). 2. 21 to 80 years of age inclusive. 3. If patients are taking riluzole for ALS, they must be on a stable dose for at least thirty days prior to the baseline visit. 4. Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB). Exclusion Criteria: 1. Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc.). 2. Clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc.) over the last 30 days. 3. Infection with the human immunodeficiency virus (HIV) 4. Limited mental capacity such that the patient cannot provide written informed consent or comply with evaluation procedures. 5. History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols. 6 Receipt of any investigational drug within the past 30 days.

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyotrophic lateral sclerosis ALS

Contacts and locations

Locations

  • VA North Texas Health Care System

    Dallas, Texas, 75216, United States

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