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.
Publication types
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Clinical Trial, Phase II
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Comparative Study
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Randomized Controlled Trial
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Research Support, N.I.H., Extramural
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Research Support, Non-U.S. Gov't
MeSH terms
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Drug Administration Schedule
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Glatiramer Acetate
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Humans
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Immunosuppressive Agents / therapeutic use*
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Immunosuppressive Agents / toxicity
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Injections / adverse effects
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Lymphocyte Activation
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Motor Neuron Disease / drug therapy*
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Motor Neuron Disease / immunology
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Peptides / administration & dosage
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Peptides / therapeutic use*
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Peptides / toxicity
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T-Lymphocytes / immunology
Substances
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Immunosuppressive Agents
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Peptides
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Glatiramer Acetate