L-Serine Safety for ALS
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
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 L-Serine safe for humans, particularly in the context of ALS?
L-Serine appears to be generally safe for humans, including those with ALS, based on a small clinical trial where it was well tolerated, although some participants experienced gastrointestinal issues. The FDA also regards L-Serine as generally safe, and it has shown neuroprotective properties in various studies.12345
How does the drug L-Serine differ from other treatments for ALS?
L-Serine is unique because it is a naturally occurring amino acid that may offer neuroprotection by activating specific enzymes involved in protein clearance, potentially slowing disease progression in ALS. Unlike other treatments, it is taken orally and is generally considered safe, with its mechanism involving the regulation of protein stress responses and autophagic-lysosomal pathways.12346
What data supports the effectiveness of the drug L-Serine for ALS?
The study on L-Serine for ALS showed that it was generally safe and did not speed up the decline in patients' abilities, but it did not provide evidence of effectiveness in improving symptoms. However, other studies on similar amino acids, like branched-chain amino acids, showed benefits in maintaining muscle strength and walking ability in ALS patients.15789
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Phoenix Neurological Associates, LTD
Lead Sponsor
Institute for Ethnomedicine
Collaborator