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

NCT03580616 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: D18095
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Outcome Measures

Primary Outcomes (1)

• Dose Tolerability Based on Subject Reporting

  Tolerability was based off of participant self-reported GI symptoms at any time during their participation.

  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

  Baseline through 12 weeks

• Efficacy Based on Pulmonary Forced Vital Capacity (FVC) as Measured by Mean Slope Through Time

  No data available

Study Arms (1)

L-Serine

EXPERIMENTAL

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

Drug: L-Serine

Interventions

L-Serine DRUG

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

L-Serine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Elijah W. Stommel: lead
• Brain Chemistry Labs: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

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MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Serine

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Elijah Stommel
• Organization: Dartmouth-Hitchcock Medical Center

elijah.w.stommel@hitchcock.org

6036505104

Study Officials

• Elijah W Stommel, MD,PHD

  Dartmouth-Htichcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Physician, Neurology

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 9, 2018
• Study Start: October 24, 2018
• Primary Completion: August 3, 2022
• Study Completion: December 20, 2022
• Last Updated: April 20, 2025
• Results First Posted: April 20, 2025

Record last verified: 2025-04

Locations

US (1)