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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03580616
Recruitment Status : Terminated (Study was terminated by the IRB due to continued noncompliance.)
First Posted : July 9, 2018
Last Update Posted : May 9, 2023
Sponsor:
Collaborator:
Brain Chemistry Labs, Institute for Ethnomedicine
Information provided by (Responsible Party):
Elijah W. Stommel, Dartmouth-Hitchcock Medical Center

Study Description
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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

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis (ALS) Drug: L-Serine Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis: A Phase IIa Study
Actual Study Start Date : October 24, 2018
Actual Primary Completion Date : August 3, 2022
Actual Study Completion Date : December 20, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Serine

Arms and Interventions
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Arm Intervention/treatment
Experimental: L-Serine
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.


Outcome Measures
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Primary Outcome Measures :
  1. Dose tolerability based on subject reporting [ Time Frame: 6 months ]
    Dose tolerability is based on subject interviews and diary assessment evaluating the presence or absence of adverse events


Secondary Outcome Measures :
  1. Efficacy based on ALS Functional Rating Scale - Revised (ALSFRS-R) [ Time Frame: Baseline, 1 year ]
    Change in ALSFRS-R questionnaire scale. The ALSFRS-R provides a physician-generated estimate of the patient's degree of functional impairment, which can be evaluated serially to objectively assess any response to treatment or progression of disease. The ALSFRS includes ten questions that ask the physician to rate his/her impression of the patients level of functional impairment in performing one of ten common tasks, e.g. climbing stairs. Each task is rated on a five-point scale from 0 = can't do, to 4 = normal ability. Individual item scores are summed to produce a reported score of between 0=worst and 40=best.

  2. Efficacy based on neurological exam [ Time Frame: Baseline, 6 months ]
    Change in neurological exams with testing of muscle flexion and extension (scale: 0 to 5 with 0 being the most impaired) reflexes (scale: absent to brisk with absent being the most impaired), and sensation (scale: normal to abnormal), cranial nerves (scale: normal to abnormal on ocular movement, yes to no on Ptosis, normal to atrophy on tongue, and normal to abnormal on tongue movement).

  3. Efficacy based on pulmonary forced vital capacity [ Time Frame: Baseline, 6 months ]
    Change in % predicted in forced vital capacity


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580616


Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Elijah W. Stommel
Brain Chemistry Labs, Institute for Ethnomedicine
Investigators
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Principal Investigator: Elijah W Stommel, MD,PHD Dartmouth-Htichcock Medical Center
More Information
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Publications:

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Responsible Party: Elijah W. Stommel, Staff Physician, Neurology, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT03580616    
Other Study ID Numbers: D18095
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: May 9, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases