Article

Placebo-controlled trial of amantadine for severe traumatic brain injury.

JFK Johnson Rehabilitation Institute, Edison, NJ, USA.
New England Journal of Medicine (impact factor: 53.3). 03/2012; 366(9):819-26. DOI:10.1056/NEJMoa1102609
Source: PubMed

ABSTRACT Amantadine hydrochloride is one of the most commonly prescribed medications for patients with prolonged disorders of consciousness after traumatic brain injury. Preliminary studies have suggested that amantadine may promote functional recovery.
We enrolled 184 patients who were in a vegetative or minimally conscious state 4 to 16 weeks after traumatic brain injury and who were receiving inpatient rehabilitation. Patients were randomly assigned to receive amantadine or placebo for 4 weeks and were followed for 2 weeks after the treatment was discontinued. The rate of functional recovery on the Disability Rating Scale (DRS; range, 0 to 29, with higher scores indicating greater disability) was compared over the 4 weeks of treatment (primary outcome) and during the 2-week washout period with the use of mixed-effects regression models.
During the 4-week treatment period, recovery was significantly faster in the amantadine group than in the placebo group, as measured by the DRS score (difference in slope, 0.24 points per week; P=0.007), indicating a benefit with respect to the primary outcome measure. In a prespecified subgroup analysis, the treatment effect was similar for patients in a vegetative state and those in a minimally conscious state. The rate of improvement in the amantadine group slowed during the 2 weeks after treatment (weeks 5 and 6) and was significantly slower than the rate in the placebo group (difference in slope, 0.30 points per week; P=0.02). The overall improvement in DRS scores between baseline and week 6 (2 weeks after treatment was discontinued) was similar in the two groups. There were no significant differences in the incidence of serious adverse events.
Amantadine accelerated the pace of functional recovery during active treatment in patients with post-traumatic disorders of consciousness. (Funded by the National Institute on Disability and Rehabilitation Research; ClinicalTrials.gov number, NCT00970944.).

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Keywords

2 weeks
 
2-week washout period
 
4 weeks
 
4-week treatment period
 
ClinicalTrials.gov number
 
Disability Rating Scale
 
DRS scores
 
greater disability
 
higher scores
 
inpatient rehabilitation
 
minimally conscious state
 
minimally conscious state 4
 
mixed-effects regression models
 
Preliminary studies
 
prespecified subgroup analysis
 
primary outcome measure
 
serious adverse events
 
traumatic brain injury
 
treatment effect
 
vegetative state