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

Phase 2

Terminated

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

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.

Recruitment & Eligibility

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

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Dose Tolerability Based on Subject Reporting	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.

Secondary Outcome Measures

Name	Time	Method
Mean ALS Functional Rating Scale - Revised (ALSFRS-R) Score	Baseline through 12 weeks	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.
Efficacy Based on Pulmonary Forced Vital Capacity (FVC) as Measured by Mean Slope Through Time	No data available