Neuropathic pain following spinal cord injury
Conditions
Interventions
Product Name: Levetiracetam
Product Code: ucb L059
Pharmaceutical Form: Tablet
INN or Proposed INN: Levetiracetam
CAS Number: 102767-28-2
Current Sponsor code: ucb L059
Other descriptive name: S-enati
Sponsors
Danish Pain Research Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: aged 18 or more neuropathic pain after a spinal cord injury (other reasons for pain is either excluded or considered highly unlikely) with a pain intensity of at least 4 on a 0-10 point numeric rating scale Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: known cerebral damage or dementia significant pain other than neuropathic pain due to spinal cord inury pregnancy or lactation allergy to levetiracetam or pyrrolidon derivates epilepsy, depression and psychiatric disorders decreased kidney function severe lever dysfunction patients who cannot cooperate due to alcohol or substance abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of levetiracetam on chronic neuropathic pain after spinal cord injury;Secondary Objective: To examine its effect on spasms and evoked pain and to study whether evoked pain is predictive of pain response;Primary end point(s): the change in median intensity of ongoing pain/unpleasantness (measured on a 10 point numeric rating scale) from baseline week to last week of treatment | — |
Countries
Denmark
Outcome results
None listed