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, low risk, low-cost
| Condition(s) | Amyotrophic Lateral Sclerosis (ALS) |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 t |
| Ages | 21 Years to 80 Years |
| Sex | All |
| Lead sponsor | Dallas VA Medical Center |
| Locations | Dallas, Texas, United States |
| Start date | 2023-11-02 |
| NCT ID | NCT04244630 |
| Official listing | https://clinicaltrials.gov/study/NCT04244630 |