Levetiracetam in spinal cord injury pain: a randomized controlled trial.
METHODS
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.


OBJECTIVE
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.


METHODS
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.
Finnerup
N B
NB
Danish Pain Research Center, University of Aarhus, Aarhus, Denmark. finnerup@ki.au.dk
Grydehøj
J
J
Bing
J
J
Johannesen
I L
IL
Biering-Sørensen
F
F
Sindrup
S H
SH
Jensen
T S
TS
D000328:Adult; D000344:Afferent Pathways / Q000187:drug effects / Q000293:injuries / Q000503:physiopathology; D000368:Aged; D000700:Analgesics / Q000627:therapeutic use; D000927:Anticonvulsants / Q000008:administration & dosage*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000077287:Levetiracetam; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000379:methods; D010147:Pain Measurement / Q000379:methods; D010148:Intractable Pain / Q000188:drug therapy* / Q000209:etiology / Q000517:prevention & control; D010276:Parasympatholytics / Q000627:therapeutic use; D010889:Piracetam / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013035:Spasm / Q000188:drug therapy / Q000209:etiology / Q000517:prevention & control; D013116:Spinal Cord / Q000187:drug effects / Q000503:physiopathology; D013119:Spinal Cord Injuries / Q000150:complications / Q000188:drug therapy*; D017211:Treatment Failure
D000700:Analgesics; D000927:Anticonvulsants; D010276:Parasympatholytics; D000077287:Levetiracetam; D010889:Piracetam