Levetiracetam in spinal cord injury pain: a randomized controlled trial

TY - JOUR

T1 - Levetiracetam in spinal cord injury pain: a randomized controlled trial

AU - Finnerup, N B

AU - Grydehøj, J

AU - Bing, J

AU - Johannesen, I L

AU - Biering-Sørensen, F

AU - Sindrup, S H

AU - Jensen, T S

N1 - Keywords: Adult; Afferent Pathways; Aged; Analgesics; Anticonvulsants; Cross-Over Studies; Double-Blind Method; Female; Humans; Male; Middle Aged; Outcome Assessment (Health Care); Pain Measurement; Pain, Intractable; Parasympatholytics; Piracetam; Spasm; Spinal Cord; Spinal Cord Injuries; Treatment Failure

PY - 2009

Y1 - 2009

N2 - 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.

AB - 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.

U2 - 10.1038/sc.2009.55

DO - 10.1038/sc.2009.55

M3 - Journal article

C2 - 19506571

SN - 1362-4393

VL - 47

SP - 861

EP - 867

JO - Spinal Cord

JF - Spinal Cord

IS - 12

ER -