Levetiracetam in Chronic Neuropathic Pain Following Spinal Cord Injury
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Effects of Levetiracetam on Chronic Neuropathic Pain Following Spinal Cord Injury: a Randomized, Double-blind, Placebo-controlled, Cross-over, Multi-center Study|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2005|
|Study Completion Date:||December 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252954
|Danish Pain Research Center, Aarhus University Hospital|
|Aarhus, Denmark, 8000|
|Clinic for Spinal Cord Injuries, Rigshospitalet|
|Hornbaek, Denmark, 3100|
|The Spinal Cord Unit, Dept of Rheumatology|
|Viborg, Denmark, 8800|
|Principal Investigator:||Nanna B Finnerup, MD||Aarhus University Hospital|