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Quick Info
Status
Currently Recruiting
Phase
2
Trial Type
Single Group Assignment, open label
Treatment Type
Drug: L-Serine
Randomization
Unknown
Enrollment
50
Start Date
10/24/2018
Contact Information
Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center, Lebanon, NH, 03756, United States
Contact: Catherine L. Andrews, RN   603-650-4633   catherine.l.andrews@hitchcock.org
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
≥ 60% (FVC)
Months Since Onset
Number of months since first symptoms of ALS.
≤ 3 years
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
unknown
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
unknown
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Yes
Open Label
Unknown
Update Notes
New inclusion criteria, other small updates
1/22/2021
Recruitment status updated
1/14/2020
No significant updates
1/15/2019
No significant updates
12/14/2018
Locations updated
10/5/2018
No significant updates
9/20/2018
Trial added
7/9/2018

Other Information

Purpose
The purpose of this study is to determine the tolerability of L-Serine oral doses for ALS patients and assess preliminary indications of efficacy
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
Details
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.
Collaborator(s)
  • Elijah W. Stommel
Trial Protocol as Published on Clinicaltrials.gov
NCT03580616 (First Published: 6/26/2018)