A Phase 2 interventional study of L-Serine in Amyotrophic Lateral Sclerosis (ALS), sponsored by Elijah W. Stommel. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-20.
Sponsored by Elijah W. Stommel · Phase 2, Interventional, and Treatment
The purpose of this study is to determine the tolerability of L-Serine oral doses for ALS patients and assess preliminary indications of efficacy
All patients will receive the same dose of the study treatment over 6 months. For each participant the study will last approximately one year with follow up visits after the treatment period of 6 months is completed. The visits will include blood draws, vital sign checks, neurological and physical exams, pulmonary testing with forced vital capacity (FVC), and questionnaires.
717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.
This study's enrollment of 43 is above the median of 35 across 461 interventional studies indexed under Motor Neuron Disease.
Browse Motor Neuron Disease studies →This is the only study on the registry with Elijah W. Stommel as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
L-Serine 15 grams orally twice a day as tolerated for 6 months
Drug: L-Serine
L-Serine is a naturally occurring dietary amino acid. It is abundant in soy products, some edible seaweeds, sweet potatoes, eggs and meat.
Dose Tolerability Based on Subject Reporting
Tolerability was based off of participant self-reported GI symptoms at any time during their participation.
Time frame: From baseline through when participants withdrew from study or up to 48 weeks
Mean ALS Functional Rating Scale - Revised (ALSFRS-R) Score
Amyotrophic lateral sclerosis functional rating scale-revised version (ALSFRS-R) is used to determine patients' assessments of their capability and independence in 12 functional activities. All 12 activities are relevant in ALS and each is scored between 0 (no function at all) and 4 (normal function). Thus the overall score for this measure can range from 0 to 48, with higher scores indicating more normal function.
Time frame: Baseline through 12 weeks
Efficacy Based on Pulmonary Forced Vital Capacity (FVC) as Measured by Mean Slope Through Time
Time frame: No data available
Routine monitoring revealed major noncompliance that was not adequately addressed by the Sponsor-Investigator. Subsequently, the study was terminated by the Institutional Review Board (IRB). The IRB determined these deviations compromised the integrity of the data. Furthermore, the study data collected have been deemed unreliable due to issues related to the study's conduct.
| Milestone | L-Serine |
|---|---|
| Started | 43 |
| Was determined eligible at screening visit | 37 |
| Included in interim analysis | 28 |
| Completed | 0 |
| Not completed | 43 |
Tolerability was based off of participant self-reported GI symptoms at any time during their participation.
| Participants | L-Serine |
|---|---|
| Diarrhea | 7 |
| Bowel Obstruction | 1 |
| Nausea | 8 |
Amyotrophic lateral sclerosis functional rating scale-revised version (ALSFRS-R) is used to determine patients' assessments of their capability and independence in 12 functional activities. All 12 activities are relevant in ALS and each is scored between 0 (no function at all) and 4 (normal function). Thus the overall score for this measure can range from 0 to 48, with higher scores indicating more normal function.
| Mean score | L-Serine |
|---|---|
| Mean ALS Functional Rating Scale - Revised (ALSFRS-R) Score | 28.8732 ± 5.3734 |
No measurements were reported for this outcome.
Collected over The adverse event data was collected from baseline through when participants withdrew from study or up to 48 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| L-Serine | 1/37 (2.7%) | 12/37 (32.4%) | 31/37 (83.8%) |
| Event | L-Serine |
|---|---|
| Breathing difficulty/Ventilation IssuesRespiratory, thoracic and mediastinal disorders | 3/37 |
| Gastric tube PlacementSurgical and medical procedures | 2/37 |
| Respiratory ArrestCardiac disorders | 1/37 |
| Bowel ObstructionGastrointestinal disorders | 1/37 |
| Viral infection and mild rhabdomyolysisMusculoskeletal and connective tissue disorders | 1/37 |
| Suicide AttemptPsychiatric disorders | 1/37 |
| Pre-Planned Surgical ProcedureSurgical and medical procedures | 1/37 |
| Worsening weakness and FallsMusculoskeletal and connective tissue disorders | 1/37 |
| Bimalleolar Fracture with Lateral SubluxationMusculoskeletal and connective tissue disorders | 1/37 |
| Event | L-Serine |
|---|---|
| FallsMusculoskeletal and connective tissue disorders | 16/37 |
| NauseaGastrointestinal disorders | 8/37 |
| DiarrheaGastrointestinal disorders | 7/37 |
Participants determined to be eligible at screening visit
| Age, Customized(Participants) | L-Serine |
|---|---|
| 50 - 59 years | 14 |
| 60 - 69 years | 12 |
| 70 - 79 years | 11 |
| Sex: Female, Male(Participants) | L-Serine |
|---|---|
| Female | 12 |
| Male | 25 |
| Race (NIH/OMB)(Participants) | L-Serine |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 35 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(participants) | L-Serine |
|---|---|
| United States | 37 |
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