Randomized controlled phase II trial of glatiramer acetate in ALS

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...

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Bibliographic Details
Published inNeurology Vol. 66; no. 7; p. 1117
Main Authors Gordon, P H, Doorish, C, Montes, J, Mosley, R L, Mosely, R L, Diamond, B, Macarthur, R B, Weimer, L H, Kaufmann, P, Hays, A P, Rowland, L P, Gendelman, H E, Przedborski, S, Mitsumoto, H
Format Journal Article
LanguageEnglish
Published United States 11.04.2006
Subjects
Drug Administration Schedule
Glatiramer Acetate
Humans
Immunosuppressive Agents - therapeutic use
Immunosuppressive Agents - toxicity
Injections - adverse effects
Lymphocyte Activation
Motor Neuron Disease - drug therapy
Motor Neuron Disease - immunology
Peptides - administration & dosage
Peptides - therapeutic use
Peptides - toxicity
T-Lymphocytes - immunology
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Summary: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.
ISSN:1526-632X
DOI:10.1212/01.wnl.0000204235.81272.e2