Levetiracetam in spinal cord injury pain: a randomized controlled trial

Study design: A randomized, double-blind, placebo-controlled, crossover, multicenter trial. A 1-week baseline period was followed by two treatment periods of 5 weeks duration with levetiracetam increased from 500mg b.i.d. to a maximum of 1500mg b.i.d. separated by a 1-week washout period. Objectives: The objective of the study was primarily to evaluate the efficacy of the anticonvulsant levetiracetam in patients with spinal cord injury (SCI) at-and below-level pain and secondarily to evaluate the effect on spasm severity. Setting: Outpatients at two spinal cord units and a pain center. Methods: Patients were allowed to continue their usual pain treatment at a constant dose. The primary outcome measure was the change in median daily pain score (on a 0-10 point numeric rating scale) from 1-week baseline period to the last week of each treatment period. Secondary outcome measures included pain relief of at-and below-level pain, allodynia, spasms and spasticity. Results: A total of 36 patients with SCI at-and or below-level pain were enrolled. Of these, 24 patients completed the trial. We found no effect of levetiracetam on the primary (P = 0.46) or any of the secondary outcome measures. Only two patients continued levetiracetam treatment following the trial, and one patient was still in levetiracetam treatment at the 6-month follow-up. Levetiracetam was generally well tolerated with no serious adverse events. Conclusions: Levetiracetam does not relieve neuropathic pain or spasm severity following spinal cord injury. Spinal Cord (2009) 47, 861-867; doi:10.1038/sc.2009.55; published online 9 June 2009