NCT04244630 Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial
| NCT ID | NCT04244630 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Dallas VA Medical Center |
| Condition | Amyotrophic Lateral Sclerosis (ALS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-11-02 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2023-11-02 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Olaf Stuve, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Dallas VA Medical Center
Frequently Asked Questions
Who can join the NCT04244630 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 80 Years, studying Amyotrophic Lateral Sclerosis (ALS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04244630 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04244630 currently recruiting?
Yes, NCT04244630 is actively recruiting participants. Contact the research team at rehana.hussain@utsouthwestern.edu for enrollment information.
Where is the NCT04244630 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT04244630 clinical trial?
NCT04244630 is sponsored by Dallas VA Medical Center. The principal investigator is Olaf Stuve, M.D., Ph.D. at Dallas VA Medical Center. The trial plans to enroll 60 participants.
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