Placebo-controlled phase I/II studies of minocycline in amyotrophic lateral sclerosis

被引:108
作者
Gordon, PH
Moore, DH
Gelinas, DF
Qualls, C
Meister, ME
Werner, J
Mendoza, M
Mass, J
Kushner, G
Miller, RG
机构
[1] Columbia Univ, Dept Neurol, New York, NY USA
[2] Calif Pacific Med Ctr, Dept Neurol, San Francisco, CA USA
[3] Calif Pacific Med Ctr, Dept Biostat, San Francisco, CA USA
[4] Univ New Mexico, Dept Neurol, Albuquerque, NM USA
[5] Univ New Mexico, Dept Biostat, Albuquerque, NM USA
关键词
D O I
10.1212/01.WNL.0000125321.92112.7E
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
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.
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收藏
页码:1845 / 1847
页数:3
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