Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis (ALS)

(ALS Trial)

Overseen By Stephanie E Langlois

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Elijah W. Stommel

Must not be taking: Chemotherapy, Radiation therapy

Disqualifiers: Stroke, Diabetes, Hypertension, Alzheimer's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

43 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if taking L-Serine by mouth is safe for people with ALS and if it might help them. All participants will take the same dose for several months. The study will last about a year, including follow-up visits to check their health. L-Serine has been previously tested for ALS patients, focusing on safety.

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.

How does the drug L-Serine differ from other treatments for this condition?

L-Serine is unique because it is a 'conditionally essential' amino acid, meaning the body cannot always produce enough of it, especially under certain conditions. It plays a crucial role in brain function and development, and its therapeutic benefits have been explored in various neurological and psychiatric disorders, making it distinct from other treatments that may not address these specific metabolic needs. ^{1 2 3 4 5}

Research Team

Elijah W Stommel, MD,PHD

Principal Investigator

Dartmouth-Htichcock Medical Center

Eligibility Criteria

Inclusion Criteria

Diagnosis of probable or definite ALS

ALSFRS-R score >25 and FVC score ≥ 60% predicted

If currently taking Riluzole and/or Edaravone/Radicava must be on stable dose for 3 months prior to Baseline/Screening. If the dosing has not been stable for 3 months prior to Baseline/Screening or if stopped due to an adverse event, the waiting period off the medication will be 7 days. If not on either of these medications may start if desired either or both medications after enrollment into study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive L-Serine 15 grams orally twice a day for 6 months

6 months

Regular visits for blood draws, vital sign checks, neurological and physical exams, pulmonary testing, and questionnaires

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up visits after treatment period

Treatment Details

Interventions

• L-Serine

Participant Groups

Group I: L-Serine Experimental Treatment 1 Intervention

L-Serine 15 grams orally twice a day as tolerated for 6 months

Who Is Running the Clinical Trial?

Elijah W. Stommel

Lead Sponsor

Trials

1

Recruited

40+

Brain Chemistry Labs

Collaborator

Trials

2

Recruited

70+

Brain Chemistry Labs, Institute for Ethnomedicine

Collaborator

Trials

2

Recruited

70+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Serine Metabolism in Health and Disease and as a Conditionally Essential Amino Acid. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Serine biosynthesis and transport defects. [2021]

3. England pubmed.ncbi.nlm.nih.gov

L-serine in disease and development. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Synthesis and release of L-serine by rat astroglia-rich primary cultures. [2016]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Transcriptional Activation of Chac1 and Other Atf4-Target Genes Induced by Extracellular l-Serine Depletion is negated with Glycine Consumption in Hepa1-6 Hepatocarcinoma Cells. [2021]