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GORDON, P. H; MOORE, D. H; GELINAS, D. F; QUALLS, C; MEISTER, M. E; WERNER, J; MENDOZA, M; MASS, J; KUSHNER, G; MILLER, R. G
Neurology, 05/2004, Letnik: 62, Številka: 10Journal Article
Two double-blind, randomized, placebo-controlled feasibility trials of minocycline in ALS were conducted. In Trial 1, 19 subjects received 200 mg/day or placebo for 6 months; there were no significant differences in adverse events (AE). In Trial 2, 23 subjects received up to 400 mg/day in an 8-month crossover trial. The mean tolerated dose was 387 mg/day, there was a trend toward more gastrointestinal AE (p = 0.057), and blood urea nitrogen and liver enzymes became elevated (p < 0.05). Using these data, the authors have designed and launched a phase III trial.
