L-Serine Safety for ALS

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Phoenix Neurological Associates, LTD

Disqualifiers: FVC below 60%, Motor neuron disease over 3 years, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

20 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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. ^{1 6 7 8 9}

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.

Research Team

Todd D Levine, MD

Principal Investigator

Phoenix Neurological Associates, LTD

Eligibility Criteria

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

Able to provide informed consent to and comply with all medical procedures

I am either male or female.

My ALS functional rating score is above 25.

Exclusion Criteria

My lung capacity is below 60% of the expected.

I am younger than 18 or older than 85.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

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.

Participant Groups

Group I: 2.5 grams BID Active Control 1 Intervention

5 Patients will be evenly randomized into this group

Group II: .5 grams BID Active Control 1 Intervention

5 Patients will be evenly randomized into this group

Group III: 7.5 grams BID Active Control 1 Intervention

5 Patients will be evenly randomized into this group

Group IV: 15 grams BID Active Control 1 Intervention

5 Patients will be evenly randomized into this group

Who Is Running the Clinical Trial?

Phoenix Neurological Associates, LTD

Lead Sponsor

Trials

8

Recruited

220+

Institute for Ethnomedicine

Collaborator

Trials

1

Recruited

20+

Findings from Research

In a randomized controlled trial involving 20 ALS patients, glatiramer acetate was found to have a manageable safety profile, with injection reactions being the most common adverse event.

The treatment led to enhanced lymphocyte proliferation, indicating a potential positive immune response, which supports the need for larger trials to further explore dosing and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled phase II trial of glatiramer acetate in ALS. Gordon, PH., Doorish, C., Montes, J., et al.[2015]

In a one-year double-blind trial involving 22 patients with amyotrophic lateral sclerosis (ALS), those treated with branched-chain amino acids (12 g L-leucine, 8 g L-isoleucine, and 6.4 g L-valine) maintained muscle strength and walking ability, unlike the placebo group which experienced a decline.

The results suggest that branched-chain amino acids may provide a therapeutic benefit in preserving muscle function in ALS patients, highlighting their potential role in managing this progressive disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot trial of branched-chain aminoacids in amyotrophic lateral sclerosis. Plaitakis, A., Smith, J., Mandeli, J., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Phase I clinical trial of safety of L-serine for ALS patients. [2018]

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

Randomized controlled phase II trial of glatiramer acetate in ALS. [2015]

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

Pilot trial of branched-chain aminoacids in amyotrophic lateral sclerosis. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

A double-blind placebo-controlled trial of L-threonine in amyotrophic lateral sclerosis. [2019]

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

Cox regression and survival analysis from the tauro-urso-deoxycholic trial in amyotrophic lateral sclerosis. [2023]

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

L-Serine: a Naturally-Occurring Amino Acid with Therapeutic Potential. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Elevated plasma levels of D-serine in some patients with amyotrophic lateral sclerosis. [2021]

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

Mechanisms of L-Serine Neuroprotection in vitro Include ER Proteostasis Regulation. [2021]

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

Mechanisms of L-Serine-Mediated Neuroprotection Include Selective Activation of Lysosomal Cathepsins B and L. [2021]