Boosting mitochondrial capacity in people with ALS

Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial

This Phase 2 study will try high-dose antioxidant supplements to see if they slow disease progression in adults with ALS.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 21 Years to 80 Years
• Sex: All
• Sponsor: Dallas VA Medical Center (Federal)
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT04244630 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional trial tests higher-dose combinations of antioxidant compounds that are considered safe, building on prior EH301 results. It enrolls adults aged 21–80 with laboratory-supported probable, probable, or definite ALS by a modified El Escorial criterion, and participants on riluzole must be on a stable dose for at least 30 days. The protocol expands the original antioxidant approach by using higher doses and will measure clinical outcomes related to disease progression and function to determine if the effect is reproducible. The single-site trial is conducted at the VA North Texas Health Care System in Dallas, Texas.

Who should consider this trial

Good fit: Ideal candidates are adults 21–80 with laboratory-supported probable, probable, or definite ALS who can give informed consent and remain on a stable riluzole dose if applicable.

Not a fit: Patients with other neurodegenerative diseases, unstable medical illness, HIV infection, limited capacity to consent, or recent substance abuse are excluded and therefore unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this low-risk, low-cost antioxidant approach could meaningfully slow or halt ALS progression and be widely accessible.

How similar studies have performed: A prior trial (EH301) reported beneficial effects of antioxidant therapy in ALS, and this Phase 2 effort aims to validate and extend those findings while antioxidant strategies have otherwise shown mixed results in larger ALS populations.

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.

Where this trial is running

Dallas, Texas

• VA North Texas Health Care System — Dallas, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Olaf Stuve, M.D., Ph.D. — Dallas VA Medical Center
• Study coordinator: Rehana Hussain, M.Sc.

Conditions Amyotrophic Lateral Sclerosis