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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03580616
Other study ID # D18095
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date October 24, 2018
Est. completion date December 20, 2022

Study information

Verified date August 2023
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


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Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire

Sponsors (2)

Lead Sponsor Collaborator
Elijah W. Stommel Brain Chemistry Labs, Institute for Ethnomedicine

Country where clinical trial is conducted

United States, 

References & Publications (37)

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Outcome

Type Measure Description Time frame Safety issue
Primary Dose tolerability based on subject reporting Dose tolerability is based on subject interviews and diary assessment evaluating the presence or absence of adverse events 6 months
Secondary Efficacy based on ALS Functional Rating Scale - Revised (ALSFRS-R) 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. Baseline, 1 year
Secondary Efficacy based on neurological exam 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). Baseline, 6 months
Secondary Efficacy based on pulmonary forced vital capacity Change in % predicted in forced vital capacity Baseline, 6 months
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