Antioxidants for ALS

(MICABO-ALS Trial)

Overseen By Rehana Hussain, M.Sc.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Dallas VA Medical Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing high amounts of anti-oxidants to help patients with ALS, a severe disease with no effective treatments. The goal is to see if these substances can protect nerve cells by stopping harmful molecules from causing damage. Edaravone, an antioxidant, has shown some efficacy in slowing ALS progression by reducing reactive oxygen species.

Research Team

Olaf Stuve, M.D., Ph.D.

Principal Investigator

Dallas VA Medical Center

Eligibility Criteria

Inclusion Criteria

Patients taking riluzole for ALS 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)

A doctor has diagnosed you with ALS based on specific criteria.

Exclusion Criteria

Clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc.) over the last 30 days

Limited mental capacity such that the patient cannot provide written informed consent or comply with evaluation procedures

You have been diagnosed with other brain diseases like Parkinson's or Alzheimer's.

Treatment Details

Interventions

• Antioxidants

Participant Groups

Group I: Antioxidants Experimental Treatment 1 Intervention

Eligible patients will receive over-the-counter anti-oxidants, namely vitamin E, NAc cysteine, L-cystine, Nicotinamide and Taurursodiol at defined doses.

Antioxidants is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Vitamin E for:

• General health and wellness
• Antioxidant supplementation

Approved in European Union as Vitamin E for:

• General health and wellness
• Antioxidant supplementation

Approved in Canada as Vitamin E for:

• General health and wellness
• Antioxidant supplementation

Who Is Running the Clinical Trial?

Dallas VA Medical Center

Lead Sponsor

Trials

35

Recruited

4,800+