Levetiracetam in spinal cord injury pain: a randomized controlled trial

• Published in: Spinal cord Vol. 47; no. 12; pp. 861 - 867
• Main Authors: Finnerup, N B, Grydehøj, J, Bing, J, Johannesen, I L, Biering-Sørensen, F, Sindrup, S H, Jensen, T S
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 01-12-2009; Nature Publishing Group
• Subjects: Adult; Afferent Pathways - drug effects; Afferent Pathways - injuries; Afferent Pathways - physiopathology; Aged; Analgesics - therapeutic use; Anatomy; Anticonvulsants - administration & dosage; Biological and medical sciences; Biomedical and Life Sciences; Biomedicine; Cerebrospinal fluid. Meninges. Spinal cord; Cross-Over Studies; Double-Blind Method; Female; Human Physiology; Humans; Injuries of the nervous system and the skull. Diseases due to physical agents; Male; Medical sciences; Middle Aged; Nervous system (semeiology, syndromes); Neurochemistry; Neurology; Neuropsychology; Neurosciences; original-article; Outcome Assessment (Health Care) - methods; Pain Measurement - methods; Pain, Intractable - drug therapy; Pain, Intractable - etiology; Pain, Intractable - prevention & control; Parasympatholytics - therapeutic use; Piracetam - administration & dosage; Piracetam - analogs & derivatives; Spasm - drug therapy; Spasm - etiology; Spasm - prevention & control; Spinal Cord - drug effects; Spinal Cord - physiopathology; Spinal Cord Injuries - complications; Spinal Cord Injuries - drug therapy; Traumas. Diseases due to physical agents; Treatment Failure; spinal cord injury; neuropathic; pain; central pain; allodynia; levetiracetam; Allodynia; Nervous system diseases; Pain; Vertebral canal; Spinal cord trauma; Central nervous system disease; Spinal cord disease; Levetiracetam
• ISSN: 1362-4393; 1476-5624
• DOI: 10.1038/sc.2009.55

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.