Placebo-controlled phase I/II studies of minocycline in amyotrophic lateral sclerosis.
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.
Gordon
P H
PH
Department of Neurology, Columbia University, New York, USA. pgordon@neuro.columbia.edu
Moore
D H
DH
Gelinas
D F
DF
Qualls
C
C
Meister
M E
ME
Werner
J
J
Mendoza
M
M
Mass
J
J
Kushner
G
G
Miller
R G
RG
D000328:Adult; D000368:Aged; D000690:Amyotrophic Lateral Sclerosis / Q000188:drug therapy*; D056486:Chemical and Drug Induced Liver Injury; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D018737:Hand Strength; D006801:Humans; D007674:Kidney Diseases / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D008911:Minocycline / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D018696:Neuroprotective Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D012132:Respiratory Muscles / Q000187:drug effects; D019782:Riluzole / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome
D018696:Neuroprotective Agents; D019782:Riluzole; D008911:Minocycline