NCT00252954

Levetiracetam in Chronic Neuropathic Pain Following Spinal Cord Injury

Effects of Levetiracetam on Chronic Neuropathic Pain Following Spinal Cord Injury: a Randomized, Double-blind, Placebo-controlled, Cross-over, Multi-center Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Danish Pain Research Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Injuries, Spinal Cord
• Pain

Interventions

Type	Name	Description
DRUG	Levetiracetam	Tablets 2000-3000 mg per day

Timeline

• Start date: 2005-11-01
• Primary completion: 2008-03-01
• Completion: 2008-12-01
• First posted: 2005-11-15
• Last updated: 2009-08-20

Locations

3 sites across 1 country: Denmark