Randomized controlled phase II trial of glatiramer acetate in ALS.
rct · Level II
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- Record sourced from PubMed, PMID 16606934.
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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.
Medical subject headings
- Immunosuppressive Agents
- Motor Neuron Disease
- Peptides