Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial
Recruiting now · Phase 2
Conditions studied: Amyotrophic Lateral Sclerosis (ALS)
In brief
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.
Key facts
- Study ID
- NCT04244630
- Run by
- Dallas VA Medical Center
- People needed
- 60
- Starts
- 2023-11-02
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2025-08-24
Who can join
Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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)
- Limited mental capacity such that the patient cannot provide written informed consent or comply with evaluation procedures.
- 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.
Where it is running
- VA North Texas Health Care System — Dallas, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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