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| Sponsors and Collaborators: |
Danish Pain Research Center UCB NORDIC A/S |
| Information provided by: | Danish Pain Research Center |
| ClinicalTrials.gov Identifier: | NCT00252954 |
Purpose
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.
| Condition | Intervention | Phase |
|
Injuries, Spinal Cord Pain |
Drug: Levetiracetam |
Phase IV |
| MedlinePlus related topics: | Spinal Cord Injuries |
| ChemIDplus related topics: | Levetiracetam |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
| Official Title: | Effects of Levetiracetam on Chronic Neuropathic Pain Following Spinal Cord Injury: a Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Center Study |
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | June 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1: Placebo Comparator |
Drug: Levetiracetam
Tablets 2000-3000 mg per day
|
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Denmark | |||||
| Danish Pain Research Center, Aarhus University Hospital | |||||
| Aarhus, Denmark, 8000 | |||||
| The Spinal Cord Unit, Dept of Rheumatology | |||||
| Viborg, Denmark, 8800 | |||||
| Clinic for Spinal Cord Injuries, Rigshospitalet | |||||
| Hornbaek, Denmark, 3100 | |||||
| Danish Pain Research Center |
| UCB NORDIC A/S |
| Principal Investigator: | Nanna B Finnerup, MD | Aarhus University Hospital |
More Information
Danish Pain Research Center 
  |
| Responsible Party: | Danish Pain Research Center ( Nanna Brix Finnerup ) |
| Study ID Numbers: | LEV-2005 |
| First Received: | November 14, 2005 |
| Last Updated: | May 20, 2008 |
| ClinicalTrials.gov Identifier: | NCT00252954 |
| Health Authority: | Denmark: Danish Medicines Agency |
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