OBJECTIVE: To conduct a pilot study of amantadine in children with impaired 
consciousness caused by acquired brain injury, to establish design feasibility, 
and to assess the effect on level of arousal and consciousness.
DESIGN: Randomized, double-blind, placebo-controlled crossover trial. Seven 
subjects (mean age, 12.7 yrs) with an acquired brain injury (mean duration, 6 
wks) were randomized to receive either 3 wks of placebo or amantadine, followed 
by a 1-wk washout period and then 3 wks of the other agent. Main outcome 
measures were the Coma/Near-Coma Scale and Coma Recovery Scale-Revised, each 
done three times per week. Subjective evaluations of change in arousal and 
consciousness by the parent and physician were done weekly.
RESULTS: Five subjects completed the study. There was no significant difference 
in the slopes of recovery during either arm for the Coma/Near-Coma Scale (P = 
0.24) or the Coma Recovery Scale-Revised (P = 0.28), although improvements in 
consciousness were noted by the physician during weeks when amantadine was given 
(P = 0.02).
CONCLUSIONS: This study suggests that amantadine facilitates recovery of 
consciousness in pediatric acquired brain injury and provides important 
information necessary to design future more definitive studies.