title: An open-label, long-term study examining the safety and tolerability of pregabalin in Japanese patients with central neuropathic pain.
abstract: Studies of pregabalin for the treatment of central neuropathic pain have been limited to double-blind trials of 4-17 weeks in duration. The purpose of this study was to assess the long-term safety and tolerability of pregabalin in Japanese patients with central neuropathic pain. The efficacy of pregabalin was also assessed as a secondary measure.
  
  
  
  This was a 53-week, multicenter, open-label trial of pregabalin (150-600 mg/day) in Japanese patients with central neuropathic pain due to spinal cord injury, multiple sclerosis, or cerebral stroke.
  
  
  
  A total of 103 patients received pregabalin (post-stroke =60; spinal cord injury =38; and multiple sclerosis =5). A majority of patients (87.4%) experienced one or more treatment-related adverse events, most commonly somnolence, weight gain, dizziness, or peripheral edema. The adverse event profile was similar to that seen in other indications of pregabalin. Most treatment-related adverse events were mild (89.1%) or moderate (9.2%) in intensity. Pregabalin treatment improved total score, sensory pain, affective pain, visual analog scale (VAS), and present pain intensity scores on the Short-Form McGill Pain Questionnaire (SF-MPQ) and ten-item modified Brief Pain Inventory (mBPI-10) total score at endpoint compared with baseline. Improvements in SF-MPQ VAS and mBPI-10 total scores were evident in all patient subpopulations. Mean changes from baseline in SF-MPQ VAS and mBPI-10 scores at endpoint were -20.1 and -1.4, respectively.
  
  
  
  These findings demonstrate that pregabalin is generally well tolerated and provides sustained efficacy over a 53-week treatment period in patients with chronic central neuropathic pain.
authors.affiliation: Aida Memorial Rehabilitation Hospital, Moriya, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Onouchi
authors.affiliation: Kumamoto Rehabilitation Hospital, Kikuchi-Gun, Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Koga
authors.affiliation: Department of Neurology, Juntendo University School of Medicine, Tokyo, Japan.
authors.forename: Kazumasa
authors.initials: K
authors.lastname: Yokoyama
authors.affiliation: Pfizer Japan Inc., Tokyo, Japan.
authors.forename: Tamotsu
authors.initials: T
authors.lastname: Yoshiyama
keywords: cerebral stroke; clinical trial; multiple sclerosis; spinal cord injury
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