NCT04244630Active, not recruitingPhase 2
Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 22 Jan 2020
- Start date
- 2 Nov 2023
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Dallas VA Medical Center
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT04244630
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 21
- From 2 Nov 2023 to the primary completion date, 1 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc.).
- Clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc.) over the last 30 days.
- Infection with the human immunodeficiency virus (HIV)
Other
- Limited mental capacity such that the patient cannot provide written informed consent or comply with evaluation procedures.
Who the study is looking for
- A clinical diagnosis by a study investigator of laboratory-supported probable, probable, or definite ALS, according to a modified El Escorial criterion (Appendix 2).
- 21 to 80 years of age inclusive.
- If patients are taking riluzole for ALS, they must be on a stable dose for at least thirty days prior to the baseline visit.
- Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).
Age in the registry: 21 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VA North Texas Health Care System Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.