Pain Clinical Trial
Official title:
Effects of Levetiracetam on Chronic Neuropathic Pain Following Spinal Cord Injury: a Randomized, Double-blind, Placebo-controlled, Cross-over, Multi-center Study
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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