Phase I clinical trial of safety of L-serine for ALS patients

Todd D. Levine, Robert G. Miller, Walter G. Bradley, Dan H. Moore, David S. Saperstein, Lynne E. Flynn, Jonathan S. Katz, Dallas A. Forshew, James S. Metcalf, Sandra A. Banack, Paul A. Cox

Research output: Contribution to journalArticlepeer-review

38 Scopus citations


We performed a randomized, double-blind phase I clinical trial for six months on the effects of oral L-serine in patients with ALS. The protocol called for enrollment of patients with a diagnosis of probable or definite ALS, age 18–85 years, disease duration of less than three years and forced vital capacity (FVC) ≥ 60%. Patients were randomly assigned to four different oral twice-daily dose regimens (0.5, 2.5, 7.5, or 15 g/dose). Blood, urine and CSF samples, ALS Functional Rating Scale-Revised (ALSFRS-R) scores and forced vital capacity (FVC) were obtained throughout the trial. Disease progression was compared with matched historical placebo controls from five previous ALS therapeutic trials. Of 20 patients enrolled, one withdrew before receiving study drug and two withdrew with gastro-intestinal problems. Three patients died during the trial. L-serine was generally well tolerated by the patients and L-serine did not appear to accelerate functional decline of patients as measured by slope of their ALSFRS-R scores. Based on this small study, L-serine appears to be generally safe for patients with ALS.

Original languageEnglish (US)
Pages (from-to)107-111
Number of pages5
JournalAmyotrophic Lateral Sclerosis and Frontotemporal Degeneration
Issue number1-2
StatePublished - Jan 2 2017


  • ALS
  • BMAA
  • L-serine
  • phase I
  • therapeutic trial

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology


Dive into the research topics of 'Phase I clinical trial of safety of L-serine for ALS patients'. Together they form a unique fingerprint.

Cite this