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.