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Antioxidant

Personalized Treatments for ALS

Phase 2
Waitlist Available
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Sporadic or familial ALS diagnosed as per Gold Coast Criteria
Able to swallow tablets at enrollment and expected to be able to swallow tablets for the duration of the trial
Must not have
Prior side effects from any of the 4 investigational treatments being used in this trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 3, month 5 (2 months into treatment) and month 9 (6 months into treatment)
Awards & highlights

Summary

"This trial will test a new analysis platform by GenieUs to categorize ALS patients based on their blood work into four groups: neuroinflammation, oxidative stress, impaired autophagy & ax

Who is the study for?
This trial is for individuals with Motor Neuron Disease, specifically Amyotrophic Lateral Sclerosis (ALS). Participants will be categorized based on their blood work into groups reflecting different aspects of ALS pathology and receive personalized supplements accordingly.
What is being tested?
The trial tests a platform that categorizes ALS patients into four disease categories. Depending on the category—neuroinflammation, oxidative stress, impaired autophagy & axonal transport, or mitochondrial dysfunction—participants get Astaxanthin, Protandim, Melatonin, or MitoQ respectively for 6 months.
What are the potential side effects?
Potential side effects are not detailed in the provided information. However, as dietary supplements being tested may include common reactions such as allergies to ingredients or gastrointestinal discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with ALS.
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I can swallow tablets and will be able to do so for the trial's duration.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have experienced side effects from previous treatments in this trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 3, month 5 (2 months into treatment) and month 9 (6 months into treatment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 3, month 5 (2 months into treatment) and month 9 (6 months into treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
ALS Functional Rating Scale, Revised (ALSFRS-R)
Secondary study objectives
Impaired autophagy measured by Beclin-1
Mitochondrial dysfunction measured by lactate.
Neurofilament Light Chain levels
+5 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Oxidative StressExperimental Treatment1 Intervention
Study participants in this category are expected to have too many damaging "free radical" chemicals in their brains and spinal cords.
Group II: NeuroinflammationExperimental Treatment1 Intervention
Study participants in this category are expected to have inflammation in their brains and spinal cords.
Group III: Mitochondrial DysfunctionExperimental Treatment1 Intervention
Study participants in this category are expected to have motor neurons that are unable to produce normal amounts of energy.
Group IV: Impaired Autophagy and Axonal TransportExperimental Treatment1 Intervention
Study participants in this category are expected to have motor neurons that have trouble transporting materials up and down their length, and/or trouble with the turnover of damaged proteins and intracellular structures.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MitoQ
2006
Completed Phase 2
~230
Astaxanthin
2014
Completed Phase 3
~380
Protandim
2009
Completed Phase 2
~110
Melatonin
2014
Completed Phase 4
~1150

Find a Location

Who is running the clinical trial?

Temple UniversityOTHER
313 Previous Clinical Trials
88,247 Total Patients Enrolled
Duke UniversityLead Sponsor
2,424 Previous Clinical Trials
3,066,034 Total Patients Enrolled
~33 spots leftby Jun 2026
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