Purpose: To evaluate the efficacy and safety of levetiracetam on chronic neuropathic pain after spinal cord injury, and to examine its effect on spasms and evoked pain.
Study design: Randomized double-blind cross-over study of levetiracetam (Keppra) against corresponding placebo with a 1 week baseline period followed by 2 x 5 weeks treatment periods separated by a 1 week wash-out period. Methodology: Levetiracetam and corresponding placebo is gradually increased during two weeks from 500 mg x 2 daily to 1500 mg x 2 daily (1000 mg x 2 daily is allowed if 1500 mg x 2 is not tolerated), and kept on that dose for three weeks. The study will be monitored by the GCP units of Aarhus and Copenhagen University.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Tablets 2000-3000 mg per day
Danish Pain Research Center, Aarhus University Hospital
Aarhus, Denmark
Clinic for Spinal Cord Injuries, Rigshospitalet
Hornbæk, Denmark
The Spinal Cord Unit, Dept of Rheumatology
Viborg, Denmark
Change in median pain intensity (measured daily on a 10 point NRS) of spontaneous pain from baseline week to last week of treatment.
Time frame: Last week of each 5-week treatment period
Spasms and spasticity; pain relief for total, at- and below-level pain; evoked pain; escape medication; NPSI; predictive value of the presence of evoked pain; Global impression of change; sleep disturbance.
Time frame: Last day of each 5-week treatment period
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