L-Serine Safety for ALS
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety of L-Serine, a potential treatment for Amyotrophic Lateral Sclerosis (ALS), a disease affecting nerve cells in the brain and spine. Researchers explore varied dose levels to assess treatment tolerance. Participants will join one of four groups, each receiving a different dose of L-Serine. Individuals diagnosed with ALS and experiencing symptoms for less than three years may be suitable for this study. As a Phase 1/Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage ALS treatment development.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that L-Serine is likely to be safe for humans?
Research has shown that L-serine is generally safe for people with ALS. In studies, taking up to 15 grams twice a day did not cause serious issues. Although three patients died during one trial, the trial did not find that L-serine worsened their condition. Most participants did not experience major side effects, indicating it is relatively safe at the tested doses.12345
Why do researchers think this study treatment might be promising for ALS?
Unlike the standard care for ALS, which includes treatments like riluzole and edaravone that mainly aim to slow disease progression, L-Serine offers a novel approach by potentially targeting neuroprotective pathways. L-Serine is an amino acid that might help reduce the formation of toxic proteins that harm nerve cells in ALS patients. Researchers are excited because this mechanism could not only slow down the disease but also improve nerve function. Additionally, the simplicity of L-Serine’s oral administration makes it an accessible option for patients.
What evidence suggests that L-Serine might be an effective treatment for ALS?
Research suggests that L-Serine might help with ALS, a disease affecting nerve cells in the brain and spinal cord. In animal studies, L-Serine treatment reduced disease-related problems in a primate model. Previous studies in humans have found that L-Serine is generally safe at doses up to 15 grams twice a day, without worsening the disease. While these findings are hopeful, strong evidence that L-Serine directly improves ALS symptoms in humans is still lacking. Scientists continue to study its potential benefits and safety. Participants in this trial will be randomized into different dosage groups to further evaluate the safety and effects of L-Serine.23467
Who Is on the Research Team?
Todd D Levine, MD
Principal Investigator
Phoenix Neurological Associates, LTD
Are You a Good Fit for This Trial?
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%).Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive L-Serine at varied doses (0.5 gm BID, 2.5 gm BID, 7.5 gm BID, or 15 gm BID) to determine safety over six months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- L-Serine
Trial Overview
The trial is testing the safety of different doses of L-Serine, an amino acid, to see how well patients with ALS tolerate it.
How Is the Trial Designed?
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Treatment groups
Active Control
5 Patients will be evenly randomized into this group
5 Patients will be evenly randomized into this group
5 Patients will be evenly randomized into this group
5 Patients will be evenly randomized into this group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Phoenix Neurological Associates, LTD
Lead Sponsor
Institute for Ethnomedicine
Collaborator
Published Research Related to This Trial
Citations
Phase I Clinical Trial of Safety of L-serine for ALS Patients
Three patients died during the trial. L-serine was generally well tolerated by the patients and L-serine did not appear to accelerate functional decline of ...
Trials of L-serine in ALS (P3.128)
Conclusions: L-serine in doses up to 15 g twice daily appears to be safe in patients with ALS. Exploratory studies of efficacy showed no evidence that ...
Phase I clinical trial of safety of L-serine for ALS patients
Three patients died during the trial. L-serine was generally well tolerated by the patients and L-serine did not appear to accelerate functional decline of ...
4.
drugtargetreview.com
drugtargetreview.com/news/56466/l-serine-could-be-used-to-treat-als-after-promising-results-in-primate-study/L-serine could be used to treat ALS, after promising study ...
Researchers have shown that, when treated with L-serine, a non-human primate model of ALS had fewer pathologies associated with the disease.
Tolerability and Efficacy of L-Serine in Patients With ...
The purpose of this study is to determine the tolerability of L-Serine oral doses for ALS patients and assess preliminary indications of efficacy.
Determining the Safety of L-Serine in Subjects With ...
This study will determine the safety of different doses of L-serine given to ALS subjects at 0.5 gm twice daily (BID), 2.5gm BID, 7.5g BID or 15 grams BID for ...
ALSUntangled 38: L-serine
Overview. Serine is a ''non-essential'' amino acid which humans can synthesise (2). Serine exists in 2 forms: L-serine and its mirror image ...
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