Original Article
Spinal Cord advance online publication 9 June 2009; doi: 10.1038/sc.2009.55
Levetiracetam in spinal cord injury pain: a randomized controlled trial
N B Finnerup1,2, J Grydehøj2, J Bing3, I L Johannesen2, F Biering-Sørensen3,4, S H Sindrup5 and T S Jensen1,6
- 1Danish Pain Research Center, University of Aarhus, Aarhus, Denmark
- 2The Spinal Cord Injury Unit, Viborg Hospital, Viborg, Denmark
- 3Clinic for Spinal Cord Injuries, The Neuroscience Centre, Rigshospitalet, Denmark
- 4Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark
- 5Department of Neurology, Odense University Hospital, Odense, Denmark
- 6Department of Neurology, Aarhus University Hospital, Aarhus, Denmark
Correspondence: Professor NB Finnerup, Danish Pain Research Center, University of Aarhus, Building 1A, Noerrebrogade 44, Aarhus C, DK-8000, Denmark. E-mail: finnerup@ki.au.dk
Received 16 October 2008; Revised 9 April 2009; Accepted 17 April 2009; Published online 9 June 2009.
Abstract
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 500 mg b.i.d. to a maximum of 1500 mg 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.
Keywords:
levetiracetam, spinal cord injury, pain, neuropathic, central pain, allodynia
