Levetiracetam in Chronic Neuropathic Pain Following Spinal Cord Injury
Primary Purpose
Injuries, Spinal Cord, Pain
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Levetiracetam
Sponsored by
About this trial
This is an interventional treatment trial for Injuries, Spinal Cord focused on measuring Spinal cord injury, Neuropathic pain, Spasms
Eligibility Criteria
Inclusion Criteria: 1. age 18 or more 2. neuropathic pain (that have lasted at least 3 month) after a spinal cord injury with a pain intensity of at least 4 on a 0-10 point numeric rating scale Exclusion Criteria: 1. pregnancy or lactation 2. allergy to levetiracetam 3. alcohol or substance abuse, mental disease, epilepsy, depression and psychiatric disorders, severe liver disease, decreased kidney function, and known concomitant cerebral damage
Sites / Locations
- Danish Pain Research Center, Aarhus University Hospital
- Clinic for Spinal Cord Injuries, Rigshospitalet
- The Spinal Cord Unit, Dept of Rheumatology
Arms of the Study
Arm 1
Arm Type
Placebo Comparator
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Change in median pain intensity (measured daily on a 10 point NRS) of spontaneous pain from baseline week to last week of treatment.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00252954
First Posted
November 14, 2005
Last Updated
August 19, 2009
Sponsor
Danish Pain Research Center
Collaborators
UCB Nordic A/S
1. Study Identification
Unique Protocol Identification Number
NCT00252954
Brief Title
Levetiracetam in Chronic Neuropathic Pain Following Spinal Cord Injury
Official Title
Effects of Levetiracetam on Chronic Neuropathic Pain Following Spinal Cord Injury: a Randomized, Double-blind, Placebo-controlled, Cross-over, Multi-center Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Danish Pain Research Center
Collaborators
UCB Nordic A/S
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injuries, Spinal Cord, Pain
Keywords
Spinal cord injury, Neuropathic pain, Spasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Intervention Description
Tablets 2000-3000 mg per day
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. age 18 or more
2. neuropathic pain (that have lasted at least 3 month) after a spinal cord injury with a pain intensity of at least 4 on a 0-10 point numeric rating scale
Exclusion Criteria:
1. pregnancy or lactation
2. allergy to levetiracetam
3. alcohol or substance abuse, mental disease, epilepsy, depression and psychiatric disorders, severe liver disease, decreased kidney function, and known concomitant cerebral damage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nanna B Finnerup, MD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Pain Research Center, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Clinic for Spinal Cord Injuries, Rigshospitalet
City
Hornbaek
ZIP/Postal Code
3100
Country
Denmark
Facility Name
The Spinal Cord Unit, Dept of Rheumatology
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
19506571
Citation
Finnerup NB, Grydehoj J, Bing J, Johannesen IL, Biering-Sorensen F, Sindrup SH, Jensen TS. Levetiracetam in spinal cord injury pain: a randomized controlled trial. Spinal Cord. 2009 Dec;47(12):861-7. doi: 10.1038/sc.2009.55. Epub 2009 Jun 9.
Results Reference
derived
Learn more about this trial
Levetiracetam in Chronic Neuropathic Pain Following Spinal Cord Injury
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