title: Phase I clinical trial of safety of L-serine for ALS patients.
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.
authors: a Phoenix Neurological Associates , Phoenix , Arizona.
authors: Todd D
authors: TD
authors: Levine
authors: b Forbes Norris MDA/ALS Research and Treatment Center, California Pacific Medical Center , San Francisco , California.
authors: Robert G
authors: RG
authors: Miller
authors: c Department of Neurology, Miller School of Medicine , University of Miami , Miami , Florida , and.
authors: Walter G
authors: WG
authors: Bradley
authors: b Forbes Norris MDA/ALS Research and Treatment Center, California Pacific Medical Center , San Francisco , California.
authors: Dan H
authors: DH
authors: Moore
authors: a Phoenix Neurological Associates , Phoenix , Arizona.
authors: David S
authors: DS
authors: Saperstein
authors: a Phoenix Neurological Associates , Phoenix , Arizona.
authors: Lynne E
authors: LE
authors: Flynn
authors: b Forbes Norris MDA/ALS Research and Treatment Center, California Pacific Medical Center , San Francisco , California.
authors: Jonathan S
authors: JS
authors: Katz
authors: b Forbes Norris MDA/ALS Research and Treatment Center, California Pacific Medical Center , San Francisco , California.
authors: Dallas A
authors: DA
authors: Forshew
authors: d Brain Chemistry Labs, Institute for Ethnomedicine , Jackson , Wyoming , USA.
authors: James S
authors: JS
authors: Metcalf
authors: d Brain Chemistry Labs, Institute for Ethnomedicine , Jackson , Wyoming , USA.
authors: Sandra A
authors: SA
authors: Banack
authors: d Brain Chemistry Labs, Institute for Ethnomedicine , Jackson , Wyoming , USA.
authors: Paul A
authors: PA
authors: Cox
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000690:Amyotrophic Lateral Sclerosis / Q000188:drug therapy*; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012694:Serine / Q000627:therapeutic use*; D016896:Treatment Outcome; D014797:Vital Capacity / Q000187:drug effects; D055815:Young Adult
chemical_list: D012694:Serine
keywords: ALS; BMAA; L-serine; phase I; therapeutic trial