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NCT04244630 · ClinicalTrials.gov registry record · Phase 2
Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial
A Phase 2 study of Amyotrophic Lateral Sclerosis (ALS), sponsored by Dallas VA Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04244630: Recruiting Phase 2 study of Amyotrophic Lateral Sclerosis (ALS), sponsored by Dallas VA Medical Center.
NCT04244630 is a Phase 2 study of Amyotrophic Lateral Sclerosis (ALS) that is actively recruiting participants, run by Dallas VA Medical Center. The registered enrollment target is 60 participants, below the 299-participant average among 18 other Amyotrophic Lateral Sclerosis (ALS) trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04244630, a Phase 2 study of Amyotrophic Lateral Sclerosis (ALS), is actively recruiting participants, sponsored by Dallas VA Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research is to investigate the validity of a previous clinical trial named EH301, which showed beneficial effects of anti-oxidant therapies in patients with amyotrophic lateral sclerosis (ALS). If validated by this study, providing over-the-counter anti-oxidants would be a simple, low risk, low-cost approach to significantly slow or stop the progression of ALS, for which currently no effective treatment exists. It is currently thought that oxidative stress is a major cause of ALS. The study investigators are therefore planning to expand the original scope of the previous trial by including anti-oxidants at high doses that were not previously used. All of these compounds are considered safe.
Primary Outcome
The change in log serum NfL level from baseline to 12 months will be assessed using a linear mixed model and the differences in NfL level at 12 months from baseline assessed using a paired t-test.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Antioxidants
Study Locations (1)
Texas
- VA North Texas Health Care System - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-11-02 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
What NCT04244630 shows while recruiting
NCT04244630 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 299-participant average among 18 other Amyotrophic Lateral Sclerosis (ALS) trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Amyotrophic Lateral Sclerosis (ALS) appearing as the primary indexed condition, and to 1 intervention - of which Antioxidants is the first listed.
NCT04244630 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04244630 about?
NCT04244630 is a clinical study titled "Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial". The purpose of this research is to investigate the validity of a previous clinical trial named EH301, which showed beneficial effects of anti-oxidant therapies in patients with amyotrophic lateral sclerosis (ALS). If validated by this study, providing over-the-counter anti-oxidants would be a simple...
What is the current status of trial NCT04244630?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2023-11-02. Estimated completion is 2025-12.
What conditions does trial NCT04244630 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis (ALS).
What interventions are being tested in trial NCT04244630?
The interventions under investigation include: Antioxidants (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04244630?
This trial is sponsored by Dallas VA Medical Center, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04244630 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Amyotrophic Lateral Sclerosis (ALS)
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 NCT04244630's enrollment target sits among peer trials
60 13th of 18 higher than 6 of 18 other Amyotrophic Lateral Sclerosis (ALS) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis (ALS) 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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