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

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

Study & Design

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	6 months	Dose tolerability is based on subject interviews and diary assessment evaluating the presence or absence of adverse events

Secondary Outcome Measures

Name	Time	Method
Efficacy based on neurological exam	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).
Efficacy based on ALS Functional Rating Scale - Revised (ALSFRS-R)	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.
Efficacy based on pulmonary forced vital capacity	Baseline, 6 months	Change in % predicted in forced vital capacity

Recruitment & Eligibility