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 journalArticle

10 Citations (Scopus)

Abstract

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)1-5
Number of pages5
JournalAmyotrophic Lateral Sclerosis and Frontotemporal Degeneration
DOIs
StateAccepted/In press - Aug 25 2016

Fingerprint

Clinical Trials, Phase I
Serine
Safety
Vital Capacity
Disease Progression
Placebos
Urine

Keywords

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

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

Cite this

Levine, T. D., Miller, R. G., Bradley, W. G., Moore, D. H., Saperstein, D. S., Flynn, L. E., ... Cox, P. A. (Accepted/In press). Phase I clinical trial of safety of L-serine for ALS patients. Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration, 1-5. https://doi.org/10.1080/21678421.2016.1221971

Phase I clinical trial of safety of L-serine for ALS patients. / Levine, Todd D.; Miller, Robert G.; Bradley, Walter G; Moore, Dan H.; Saperstein, David S.; Flynn, Lynne E.; Katz, Jonathan S.; Forshew, Dallas A.; Metcalf, James S.; Banack, Sandra A.; Cox, Paul A.

In: Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration, 25.08.2016, p. 1-5.

Research output: Contribution to journalArticle

Levine, TD, Miller, RG, Bradley, WG, Moore, DH, Saperstein, DS, Flynn, LE, Katz, JS, Forshew, DA, Metcalf, JS, Banack, SA & Cox, PA 2016, 'Phase I clinical trial of safety of L-serine for ALS patients', Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration, pp. 1-5. https://doi.org/10.1080/21678421.2016.1221971
Levine, Todd D. ; Miller, Robert G. ; Bradley, Walter G ; Moore, Dan H. ; Saperstein, David S. ; Flynn, Lynne E. ; Katz, Jonathan S. ; Forshew, Dallas A. ; Metcalf, James S. ; Banack, Sandra A. ; Cox, Paul A. / Phase I clinical trial of safety of L-serine for ALS patients. In: Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration. 2016 ; pp. 1-5.
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