• Diana D Cardenas, Edward C Nieshoff, Kota Suda, Shin-Ichi Goto, Luis Sanin, Takehiko Kaneko, Jonathan Sporn, Bruce Parsons, Matt Soulsby, Ruoyong Yang, Ed Whalen, Joseph M Scavone, Makoto M Suzuki, and Lloyd E Knapp.
• Department of Rehabilitation Medicine, The Leonard M. Miller School of Medicine, University of Miami, FL, USA. dcardenas@med.miami.edu
• Neurology. 2013 Feb 5;80(6):533-9.

ObjectiveTo assess the efficacy and tolerability of pregabalin for the treatment of central neuropathic pain after spinal cord injury (SCI).MethodsPatients with chronic, below-level, neuropathic pain due to SCI were randomized to receive 150 to 600 mg/d pregabalin (n = 108) or matching placebo (n = 112) for 17 weeks. Pain was classified in relation to the neurologic level of injury, defined as the most caudal spinal cord segment with normal sensory and motor function, as above, at, or below level. The primary outcome measure was duration-adjusted average change in pain. Key secondary outcome measures included the change in mean pain score from baseline to end point, the percentage of patients with ≥30% reduction in mean pain score at end point, patient global impression of change scores at end point, and the change in mean pain-related sleep interference score from baseline to end point. Additional outcome measures included the medical outcomes study-sleep scale and the Hospital anxiety and depression scale.ResultsPregabalin treatment resulted in statistically significant improvements over placebo for all primary and key secondary outcome measures. Significant pain improvement was evident as early as week 1 and was sustained throughout the treatment period. Adverse events were consistent with the known safety profile of pregabalin and were mostly mild to moderate in severity. Somnolence and dizziness were most frequently reported.ConclusionsThis study demonstrates that pregabalin is effective and well tolerated in patients with neuropathic pain due to SCI.Classification Of EvidenceThis study provides class I evidence that pregabalin, 150 to 600 mg/d, is effective in reducing duration-adjusted average change in pain compared with baseline in patients with SCI over a 16-week period (p = 0.003, 95% confidence interval = -0.98, -0.20).

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