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Randomized Controlled Trial Comparative Study Clinical Trial
Placebo-controlled phase I/II studies of minocycline in amyotrophic lateral sclerosis.
- P H Gordon, D H Moore, D F Gelinas, C Qualls, M E Meister, J Werner, M Mendoza, J Mass, G Kushner, and R G Miller.
- Department of Neurology, Columbia University, New York, USA. pgordon@neuro.columbia.edu
- Neurology. 2004 May 25; 62 (10): 1845-7.
AbstractTwo 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.
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