Document Detail


Placebo-controlled trial of amantadine for severe traumatic brain injury.
MedLine Citation:
PMID:  22375973     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.).
Authors:
Joseph T Giacino; John Whyte; Emilia Bagiella; Kathleen Kalmar; Nancy Childs; Allen Khademi; Bernd Eifert; David Long; Douglas I Katz; Sooja Cho; Stuart A Yablon; Marianne Luther; Flora M Hammond; Annette Nordenbo; Paul Novak; Walt Mercer; Petra Maurer-Karattup; Mark Sherer
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, U.S. Gov't, Non-P.H.S.    
Journal Detail:
Title:  The New England journal of medicine     Volume:  366     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-03-01     Completed Date:  2012-03-08     Revised Date:  2012-06-21    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  819-26     Citation Subset:  AIM; IM    
Affiliation:
JFK Johnson Rehabilitation Institute, Edison, NJ, USA. jgiacino@partners.org
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00970944
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MeSH Terms
Descriptor/Qualifier:
Adult
Amantadine / adverse effects,  therapeutic use*
Brain Injuries / complications,  drug therapy*
Coma, Post-Head Injury / drug therapy*
Disability Evaluation
Dopamine Agents / adverse effects,  therapeutic use*
Female
Glasgow Coma Scale
Humans
Male
Persistent Vegetative State / drug therapy,  etiology
Recovery of Function
Chemical
Reg. No./Substance:
0/Dopamine Agents; 768-94-5/Amantadine
Comments/Corrections
Comment In:
N Engl J Med. 2012 Jun 21;366(25):2427; author reply 2427-8   [PMID:  22716987 ]
N Engl J Med. 2012 Jun 21;366(25):2427; author reply 2427-8   [PMID:  22716986 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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