Antioxidants for ALS (MICABO-ALS Trial)

Phase 2

Waitlist Available

Led By Olaf Stuve, M.D., Ph.D.

Research Sponsored by Dallas VA Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Eligible Conditions

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measurement of serum NfL

Secondary study objectives

Frequency of serious adverse events and adverse events.

Measurement of functional decline in ALS

Survival analysis

Other study objectives

Change in serum CK level from baseline to 12 months

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AntioxidantsExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Antioxidants

2005

Completed Phase 4

~7310

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