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

Conditions:Neurology, Neurology, Neurology
Therapuetic Areas:Neurology
Age Range:18 - Any
Start Date:October 24, 2018
End Date:June 2022
Contact:Catherine L. Andrews, RN/CCRN

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Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis: A Phase IIa Study

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,
electromyography (EMG), vital sign checks, neurological and physical exams, pulmonary testing
with forced vital capacity (FVC), and questionnaires.

Inclusion Criteria:

- Diagnosis of probable or definite ALS

- ALSFRS-R score >25 and FVC score ≥ 60% predicted

- If currently taking Riluzole and Edaravone/Radicava for 3 months prior to
Baseline/Screening or not at all

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
We found this trial at
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Phone: 603-650-5398
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
Lebanon, NH
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