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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
L-Serine is a naturally occurring dietary amino acid. It is abundant in soy products, some edible seaweeds, sweet potatoes, eggs and meat.
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
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
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