What side effects are associated with this type of intervention?

Common treatments for ALS include riluzole and edaravone. Riluzole can cause side effects such as nausea, weakness, decreased lung function, and liver damage. Edaravone may lead to bruising, gait disturbances, and allergic reactions. For neuroprotective amino acids like L-Serine, studies suggest it is generally well-tolerated, but potential side effects may include gastrointestinal discomfort and diarrhea. It is important to consult with a healthcare provider to understand the full range of possible side effects and benefits.

What prior FDA approvals exist?

The FDA has approved several treatments for Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's Disease. Riluzole, a glutamate inhibitor, was the first drug approved and has been shown to extend survival. More recently, edaravone, an antioxidant, was approved for its ability to slow the decline in daily functioning. Additionally, various investigational treatments, such as masitinib and stem cell therapies, are being studied for their potential neuroprotective effects. These treatments aim to modify disease progression and improve quality of life for ALS patients.

What other types of research exist?

Promising novel alternatives to L-Serine for ALS patients include Riluzole, Edaravone, AMX0035, and Tofersen. These treatments have shown potential in clinical trials and are being investigated for their efficacy and safety in ALS management.

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Amino Acid

L-Serine Safety for ALS

Phase 1 & 2

Waitlist Available

Led By Todd D Levine, MD

Research Sponsored by Phoenix Neurological Associates, LTD

Eligibility Criteria Checklist

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

Must have

Age 18-85

ALSFRS-R > 25

Must not have

Outside age range of 18-85

Evidence of any motor neuron disease for over 3 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety of L-Serine, an amino acid, in people with ALS. ALS patients are being studied because L-Serine might help protect their brain cells from damage caused by a harmful substance called BMAA. The study will see if different doses of L-Serine are safe and potentially beneficial. L-Serine has been previously studied and shown to be generally safe for ALS patients, with some evidence suggesting it might slow disease progression.

Who is the study for?

This trial is for men and women aged 18-85 who have been clinically diagnosed with ALS, a motor neuron disease, and can follow the study's procedures. They should be relatively early in their diagnosis (not over 3 years) and still have decent lung function (FVC above 60%).

What is being tested?

The trial is testing the safety of different doses of L-Serine, an amino acid, to see how well patients with ALS tolerate it.

What are the potential side effects?

Since this study aims to determine the safety of L-Serine in ALS patients, potential side effects are being investigated but may include gastrointestinal discomfort or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 85 years old.

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My ALS functional rating score is above 25.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am younger than 18 or older than 85.

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I have had a motor neuron disease for more than 3 years.

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My lung capacity is below 60% of the expected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-6 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

Safety of L-Serine

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Active Control

Group I: 2.5 grams BIDActive Control1 Intervention

5 Patients will be evenly randomized into this group

Group II: .5 grams BIDActive Control1 Intervention

5 Patients will be evenly randomized into this group

Group III: 7.5 grams BIDActive Control1 Intervention

5 Patients will be evenly randomized into this group

Group IV: 15 grams BIDActive Control1 Intervention

5 Patients will be evenly randomized into this group

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Lou Gehrig's Disease (ALS) often focus on neuroprotection and slowing disease progression. L-Serine, a neuroprotective amino acid, is being studied for its potential to protect neurons from damage. Similarly, ultra-high-dose methylcobalamin (a form of vitamin B12) has shown neuroprotective effects by supporting nerve health and function. Mesenchymal stem cells, which secrete neurotrophic factors, aim to protect and repair neurons. These treatments are crucial for ALS patients as they target the underlying neuronal damage, potentially slowing disease progression and improving quality of life.

Simulation of the Interactions of Arginine with Wild-Type GALT Enzyme and the Classic Galactosemia-Related Mutant p.Q188R by a Computational Approach.Antagonism by NG-nitro-L-arginine of L-glutamate-induced neurotoxicity in cultured neonatal rat cortical neurons. Prolonged application enhances neuroprotective efficacy.l-Arginine in Mitochondrial Encephalopathy, Lactic Acidosis, and Stroke-like Episodes: A Systematic Review.