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

Author(s): Gordon PH, Moore DH, Gelinas DF, Qualls C, Meister ME, Werner J, Mendoza M, Mass J, Kushner G, Miller RG

Affiliation(s): Department of Neurology, Columbia University, New York, USA. pgordon@neuro.columbia.edu

Publication date & source: 2004-05-25, Neurology., 62(10):1845-7.

Publication type: Clinical Trial; Clinical Trial, Phase II; Randomized Controlled Trial

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.