Clinical trial NCT03580616: Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis (ALS)
Official title: Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis: A Phase IIa Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Brain Chemistry Labs
First posted: 2018-07-09
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dose Tolerability Based on Subject Reporting
timeFrame: From baseline through when participants withdrew from study or up to 48 weeks
Secondary outcomes:
measure: Mean ALS Functional Rating Scale - Revised (ALSFRS-R) Score
timeFrame: Baseline through 12 weeks
measure: Efficacy Based on Pulmonary Forced Vital Capacity (FVC) as Measured by Mean Slope Through Time
timeFrame: No data available
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Htichcock Medical Center
name: Elijah W Stommel, MD,PHD
role: PRINCIPAL_INVESTIGATOR
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