Amyotrophic Lateral Sclerosis (ALS)Phase 2ALSNCT03580616

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

A Phase 2 study testing L-Serine in people with Amyotrophic Lateral Sclerosis (ALS), run by Elijah W. Stommel at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The purpose of this study is to determine the tolerability of L-Serine oral doses for ALS patients and assess preliminary indications of efficacy Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Amyotrophic Lateral Sclerosis (ALS)
What is being tested?: L-Serine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteUnited States
Study dates: 24 Oct 2018to 20 Dec 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Diagnosis of probable or definite ALS more than 3 years prior to study enrollment
Diagnosis or previous history of ischemic stroke, brain tumor, uncontrolled diabetes, renal insufficiency, or severe hypertension.
Diagnosis or previous history of comorbid progressive neurodegenerative disease such as Alzheimer's disease, Parkinson's disease, Lewy Body disease, Pick's disease, Huntington's disease, Progressive Supranuclear palsy. ALS patients diagnosed with frontotemporal dementia will not be excluded from this study.
Diagnosis or previous history of symptomatic peripheral neuropathy. Patients with findings of peripheral neuropathy on electrodiagnostic tests only but no clinical symptoms at the time of enrollment are eligible.
Undergoing any chemotherapy or radiation therapy for any cancer
Any medical condition likely to interfere with the conduct of the trial or survival of the patient during this study period
Pregnant women or women who are breast feeding
Has taken L-Serine supplement within 30 days prior to start of study drug

Trial locations and contacts

1 site in 1 country.

United States1 site

Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756

Other trials in United States

About this study

Official title: Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis: A Phase IIa Study

The purpose of this study is to determine the tolerability of L-Serine oral doses for ALS patients and assess preliminary indications of efficacy

Read the detailed description

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.

Conditions: Amyotrophic Lateral Sclerosis (ALS)
Being tested: L-Serine
Medical subject headings: Amyotrophic Lateral Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

L-SerineDrug
L-Serine is a naturally occurring dietary amino acid. It is abundant in soy products, some edible seaweeds, sweet potatoes, eggs and meat.

Study groups in NCT03580616
Study group	Role	What they receive
L-Serine	Experimental	L-Serine 15 grams orally twice a day as tolerated for 6 months Receives: Drug: L-Serine

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose Tolerability Based on Subject Reporting
Tolerability was based off of participant self-reported GI symptoms at any time during their participation.
Measured: From baseline through when participants withdrew from study or up to 48 weeks

Secondary outcomes (2)

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.
Measured: Baseline through 12 weeks
Efficacy Based on Pulmonary Forced Vital Capacity (FVC) as Measured by Mean Slope Through Time
Measured: No data available

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Oct 201820 Dec 2022

First posted9 Jul 2018
Study start24 Oct 2018
Primary completion3 Aug 2022
Study completion20 Dec 2022

Why it stopped: Study was terminated by the IRB due to continued noncompliance.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (37)Papers the sponsor has linked to this study.
Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03580616
Sponsor's protocol ID: D18095
Acronym: ALS
Status last verified: Apr 2025
First submitted: 26 Jun 2018
Last updated: 20 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Abe K, Itoyama Y, Sobue G, Tsuji S, Aoki M, Doyu M, Hamada C, Kondo K, Yoneoka T, Akimoto M, Yoshino H; Edaravone ALS Study Group. Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Dec;15(7-8):610-7. doi: 10.3109/21678421.2014.959024. Epub 2014 Oct 6.
PubMed 25286015
Andrew AS, Caller TA, Tandan R, Duell EJ, Henegan PL, Field NC, Bradley WG, Stommel EW. Environmental and Occupational Exposures and Amyotrophic Lateral Sclerosis in New England. Neurodegener Dis. 2017;17(2-3):110-116. doi: 10.1159/000453359. Epub 2017 Jan 26.
PubMed 28122372
Brannath W, Burger HU, Glimm E, Stallard N, Vandemeulebroecke M, Wassmer G. Comments on the draft guidance on "adaptive design clinical trials for drugs and biologics" of the U.S. Food and Drug Administration. J Biopharm Stat. 2010 Nov;20(6):1125-31. doi: 10.1080/10543406.2010.514453.
PubMed 21058108
Banack SA, Murch SJ, Cox PA. Neurotoxic flying foxes as dietary items for the Chamorro people, Marianas Islands. J Ethnopharmacol. 2006 Jun 15;106(1):97-104. doi: 10.1016/j.jep.2005.12.032. Epub 2006 Feb 7.
PubMed 16457975
Braak H, Braak E. Staging of Alzheimer's disease-related neurofibrillary changes. Neurobiol Aging. 1995 May-Jun;16(3):271-8; discussion 278-84. doi: 10.1016/0197-4580(95)00021-6.
PubMed 7566337
Caller TA, Andrews A, Field NC, Henegan PL, Stommel EW. The Epidemiology of Amyotrophic Lateral Sclerosis in New Hampshire, USA, 2004-2007. Neurodegener Dis. 2015;15(4):202-6. doi: 10.1159/000374117. Epub 2015 Apr 16.
PubMed 25896575
Canu N, Ciotti MT, Pollegioni L. Serine racemase: a key player in apoptosis and necrosis. Front Synaptic Neurosci. 2014 Apr 21;6:9. doi: 10.3389/fnsyn.2014.00009. eCollection 2014.
PubMed 24795622
Cox PA, Banack SA, Murch SJ. Biomagnification of cyanobacterial neurotoxins and neurodegenerative disease among the Chamorro people of Guam. Proc Natl Acad Sci U S A. 2003 Nov 11;100(23):13380-3. doi: 10.1073/pnas.2235808100.
PubMed 14612559
Cox PA, Davis DA, Mash DC, Metcalf JS, Banack SA. Dietary exposure to an environmental toxin triggers neurofibrillary tangles and amyloid deposits in the brain. Proc Biol Sci. 2016 Jan 27;283(1823):20152397. doi: 10.1098/rspb.2015.2397.
PubMed 26791617
de Koning TJ. Treatment with amino acids in serine deficiency disorders. J Inherit Metab Dis. 2006 Apr-Jun;29(2-3):347-51. doi: 10.1007/s10545-006-0269-0.
PubMed 16763900
Desai JR, Bowen EA, Danielson MM, Allam RR, Cantor MN. Creation and implementation of a historical controls database from randomized clinical trials. J Am Med Inform Assoc. 2013 Jun;20(e1):e162-8. doi: 10.1136/amiajnl-2012-001257. Epub 2013 Feb 28.
PubMed 23449762
Dunlop RA, Cox PA, Banack SA, Rodgers KJ. The non-protein amino acid BMAA is misincorporated into human proteins in place of L-serine causing protein misfolding and aggregation. PLoS One. 2013 Sep 25;8(9):e75376. doi: 10.1371/journal.pone.0075376. eCollection 2013.
PubMed 24086518
Dunlop RA, Powell J, Guillemin GJ, Cox PA. Mechanisms of L-Serine Neuroprotection in vitro Include ER Proteostasis Regulation. Neurotox Res. 2018 Jan;33(1):123-132. doi: 10.1007/s12640-017-9829-3. Epub 2017 Nov 2.
PubMed 29098664
Dunlop RA, Powell JT, Metcalf JS, Guillemin GJ, Cox PA. L-Serine-Mediated Neuroprotection Includes the Upregulation of the ER Stress Chaperone Protein Disulfide Isomerase (PDI). Neurotox Res. 2018 Jan;33(1):113-122. doi: 10.1007/s12640-017-9817-7. Epub 2017 Oct 3.
PubMed 28975502
Fiandaca MS, Kapogiannis D, Mapstone M, Boxer A, Eitan E, Schwartz JB, Abner EL, Petersen RC, Federoff HJ, Miller BL, Goetzl EJ. Identification of preclinical Alzheimer's disease by a profile of pathogenic proteins in neurally derived blood exosomes: A case-control study. Alzheimers Dement. 2015 Jun;11(6):600-7.e1. doi: 10.1016/j.jalz.2014.06.008. Epub 2014 Aug 15.
PubMed 25130657

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Amyotrophic Lateral Sclerosis (ALS) trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis: A Phase IIa Study
ClinicalTrials.gov ID: NCT03580616
Acronym / sponsor ID: ALS / D18095
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study was terminated by the IRB due to continued noncompliance.
Enrolment: 43 participants (actual)
Lead sponsor: Elijah W. StommelUniversity, hospital or other
Collaborators: Brain Chemistry Labs
Study start: 24 Oct 2018 (actual)
Primary completion: 3 Aug 2022 (actual)
Study completion: 20 Dec 2022 (actual)
First posted: 9 Jul 2018 (actual)
Results: Posted 20 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine the tolerability of L-Serine oral doses for ALS patients and assess preliminary indications of efficacy

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
L-Serine	Experimental	Drug: L-SerineL-Serine 15 grams orally twice a day as tolerated for 6 months

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (8 listed)

Diagnosis of probable or definite ALS more than 3 years prior to study enrollment
Diagnosis or previous history of ischemic stroke, brain tumor, uncontrolled diabetes, renal insufficiency, or severe hypertension.
Diagnosis or previous history of comorbid progressive neurodegenerative disease such as Alzheimer's disease, Parkinson's disease, Lewy Body disease, Pick's disease, Huntington's disease, Progressive Supranuclear palsy. ALS patients diagnosed with frontotemporal dementia will not be excluded from this study.
Diagnosis or previous history of symptomatic peripheral neuropathy. Patients with findings of peripheral neuropathy on electrodiagnostic tests only but no clinical symptoms at the time of enrollment are eligible.
Undergoing any chemotherapy or radiation therapy for any cancer

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
L-SerineL-Serine is a naturally occurring dietary amino acid. It is abundant in soy products, some edible seaweeds, sweet potatoes, eggs and meat.	Drug	L-Serine

Primary outcome

Dose Tolerability Based on Subject Reporting
Time frame: From baseline through when participants withdrew from study or up to 48 weeks
Tolerability was based off of participant self-reported GI symptoms at any time during their participation.

2 secondary outcomes

Mean ALS Functional Rating Scale - Revised (ALSFRS-R) Score
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

Results and safety

Results posted to the registry on 20 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
L-Serine	43	0

Primary outcome: Dose Tolerability Based on Subject Reporting

Time frame: From baseline through when participants withdrew from study or up to 48 weeks. Count of participants. Unit: Participants

Measure	L-Serine n = 37
Diarrhea	7
Bowel Obstruction	1
Nausea	8

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse event data was collected from baseline through when participants withdrew from study or up to 48 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
L-Serine	12 of 37 (32.4%)	31 of 37 (83.8%)	1 of 37

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25286015Abe K, Itoyama Y, Sobue G, Tsuji S, Aoki M, Doyu M, Hamada C, Kondo K, Yoneoka T, Akimoto M, Yoshino H; Edaravone ALS Study Group. Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Dec;15(7-8):610-7. doi: 10.3109/21678421.2014.959024. Epub 2014 Oct 6.
Background: PubMed 28122372Andrew AS, Caller TA, Tandan R, Duell EJ, Henegan PL, Field NC, Bradley WG, Stommel EW. Environmental and Occupational Exposures and Amyotrophic Lateral Sclerosis in New England. Neurodegener Dis. 2017;17(2-3):110-116. doi: 10.1159/000453359. Epub 2017 Jan 26.
Background: PubMed 21058108Brannath W, Burger HU, Glimm E, Stallard N, Vandemeulebroecke M, Wassmer G. Comments on the draft guidance on "adaptive design clinical trials for drugs and biologics" of the U.S. Food and Drug Administration. J Biopharm Stat. 2010 Nov;20(6):1125-31. doi: 10.1080/10543406.2010.514453.
Background: PubMed 16457975Banack SA, Murch SJ, Cox PA. Neurotoxic flying foxes as dietary items for the Chamorro people, Marianas Islands. J Ethnopharmacol. 2006 Jun 15;106(1):97-104. doi: 10.1016/j.jep.2005.12.032. Epub 2006 Feb 7.
Background: PubMed 7566337Braak H, Braak E. Staging of Alzheimer's disease-related neurofibrillary changes. Neurobiol Aging. 1995 May-Jun;16(3):271-8; discussion 278-84. doi: 10.1016/0197-4580(95)00021-6.
Background: PubMed 25896575Caller TA, Andrews A, Field NC, Henegan PL, Stommel EW. The Epidemiology of Amyotrophic Lateral Sclerosis in New Hampshire, USA, 2004-2007. Neurodegener Dis. 2015;15(4):202-6. doi: 10.1159/000374117. Epub 2015 Apr 16.
Background: PubMed 24795622Canu N, Ciotti MT, Pollegioni L. Serine racemase: a key player in apoptosis and necrosis. Front Synaptic Neurosci. 2014 Apr 21;6:9. doi: 10.3389/fnsyn.2014.00009. eCollection 2014.
Background: PubMed 14612559Cox PA, Banack SA, Murch SJ. Biomagnification of cyanobacterial neurotoxins and neurodegenerative disease among the Chamorro people of Guam. Proc Natl Acad Sci U S A. 2003 Nov 11;100(23):13380-3. doi: 10.1073/pnas.2235808100.
Background: PubMed 26791617Cox PA, Davis DA, Mash DC, Metcalf JS, Banack SA. Dietary exposure to an environmental toxin triggers neurofibrillary tangles and amyloid deposits in the brain. Proc Biol Sci. 2016 Jan 27;283(1823):20152397. doi: 10.1098/rspb.2015.2397.
Background: PubMed 16763900de Koning TJ. Treatment with amino acids in serine deficiency disorders. J Inherit Metab Dis. 2006 Apr-Jun;29(2-3):347-51. doi: 10.1007/s10545-006-0269-0.
Background: PubMed 23449762Desai JR, Bowen EA, Danielson MM, Allam RR, Cantor MN. Creation and implementation of a historical controls database from randomized clinical trials. J Am Med Inform Assoc. 2013 Jun;20(e1):e162-8. doi: 10.1136/amiajnl-2012-001257. Epub 2013 Feb 28.
Background: PubMed 24086518Dunlop RA, Cox PA, Banack SA, Rodgers KJ. The non-protein amino acid BMAA is misincorporated into human proteins in place of L-serine causing protein misfolding and aggregation. PLoS One. 2013 Sep 25;8(9):e75376. doi: 10.1371/journal.pone.0075376. eCollection 2013.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elijah W Stommel, MD,PHD principal investigator

Dartmouth-Htichcock Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing L-Serine in people with Amyotrophic Lateral Sclerosis (ALS), run by Elijah W. Stommel at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Tolerability Based on Subject Reporting (time frame: From baseline through when participants withdrew from study or up to 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03580616, which also lists 37 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.