L-Serine for ALS
(ALS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the tolerance of the supplement L-Serine in people with ALS, a nervous system disease that weakens muscles, and its potential to alleviate symptoms. Participants will take L-Serine twice daily for six months. The trial seeks individuals diagnosed with ALS within the past three years who are stable on their current ALS medications. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications to join the trial?
The trial does not require you to stop your current medications, but if you are taking Riluzole or Edaravone/Radicava, you must be on a stable dose for 3 months before starting the trial. If you recently stopped these medications due to side effects, you need to wait 7 days before joining.
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 use. It is not considered a dangerous substance and does not pose major health risks when handled normally. Safety guidelines indicate no special precautions are needed, and it is not deemed harmful. However, L-Serine is flammable, so it should be kept away from open flames and food.
In past studies, participants used L-Serine without major side effects. Some minor reactions, such as skin irritation or needing fresh air if inhaled, might occur, but these are common precautions and not specific to L-Serine being particularly risky.
Overall, based on current safety information, L-Serine appears to be a safe treatment option.12345Why do researchers think this study treatment might be promising for ALS?
Unlike the standard ALS treatments, which often focus on managing symptoms through medications like riluzole and edaravone, L-Serine offers a different approach by potentially providing neuroprotective benefits. L-Serine is a naturally occurring amino acid that may help reduce the misfolding of proteins, a process thought to contribute to ALS progression. Researchers are excited because it represents a novel way to target the disease's underlying mechanisms, which could slow its progression and improve patients' quality of life.
What evidence suggests that L-Serine might be an effective treatment for ALS?
Research has shown that L-Serine might assist with nerve and brain issues. In studies with mice, L-Serine repaired damaged white matter in the brain. Another study found that L-Serine slowed the progression of a genetic nerve disorder called HSAN1 in patients. These findings suggest that L-Serine could potentially aid in nerve and brain conditions. However, these results are not specific to ALS, the focus of this trial. More research is needed to determine its effectiveness for ALS patients. Participants in this trial will receive L-Serine to evaluate its effects on ALS.678910
Who Is on the Research Team?
Elijah W Stommel, MD,PHD
Principal Investigator
Dartmouth-Htichcock Medical Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive L-Serine 15 grams orally twice a day for 6 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?
Elijah W. Stommel
Lead Sponsor
Brain Chemistry Labs
Collaborator
Brain Chemistry Labs, Institute for Ethnomedicine
Collaborator