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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
Danish Pain Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Injuries, Spinal Cord focused on measuring Spinal cord injury, Neuropathic pain, Spasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 14, 2005
Last Updated
August 19, 2009
Sponsor
Danish Pain Research Center
Collaborators
UCB Nordic A/S
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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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