title: Randomized controlled phase II trial of glatiramer acetate in ALS.
abstract: The authors conducted a randomized controlled trial to test the safety and immunology of glatiramer acetate in ALS. Twenty treated patients were randomly assigned to daily or biweekly injections. Ten control patients were selected from another trial and followed up concurrently. Injection reactions were the only common adverse event (p = 0.01). Treated patients showed enhanced lymphocyte proliferation (p = 0.02). The safety profile and immune effects support conducting larger trials of dose selection and efficacy.
authors.affiliation: Department of Neurology, Columbia University, NY, USA. phg8@columbia.edu
authors.forename: P H
authors.initials: PH
authors.lastname: Gordon
authors.forename: C
authors.initials: C
authors.lastname: Doorish
authors.forename: J
authors.initials: J
authors.lastname: Montes
authors.forename: R L
authors.initials: RL
authors.lastname: Mosley
authors.forename: R L
authors.initials: RL
authors.lastname: Mosely
authors.forename: B
authors.initials: B
authors.lastname: Diamond
authors.forename: R B
authors.initials: RB
authors.lastname: Macarthur
authors.forename: L H
authors.initials: LH
authors.lastname: Weimer
authors.forename: P
authors.initials: P
authors.lastname: Kaufmann
authors.forename: A P
authors.initials: AP
authors.lastname: Hays
authors.forename: L P
authors.initials: LP
authors.lastname: Rowland
authors.forename: H E
authors.initials: HE
authors.lastname: Gendelman
authors.forename: S
authors.initials: S
authors.lastname: Przedborski
authors.forename: H
authors.initials: H
authors.lastname: Mitsumoto
mesh_terms: D004334:Drug Administration Schedule; D000068717:Glatiramer Acetate; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use* / Q000633:toxicity; D007267:Injections / Q000009:adverse effects; D008213:Lymphocyte Activation; D016472:Motor Neuron Disease / Q000188:drug therapy* / Q000276:immunology; D010455:Peptides / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity; D013601:T-Lymphocytes / Q000276:immunology
chemical_list: D007166:Immunosuppressive Agents; D010455:Peptides; D000068717:Glatiramer Acetate