Clinical Trial: Levetiracetam for Painful Polyneuropathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Double-blind, Randomised, Placebo-controlled Trial of the Effect of Levetiracetam on Painful Polyneuropathy

Brief Summary: Polyneuropathy of different etiologies is often associated with pain. The standard treatment of this pain is anticonvulsants or antidepressants, but none of these treatment are effective or tolerable for all patients. Levetiracetam is a newer anticonvulsant and it is the hypothesis is that it could relieve neuropathic pain in polyneuropathy. This is a randomised, double-blind, placebo-controlled, cross-over trial on the effect of levetiracetam 3.000 mg/day on pain in polyneuropathy

Detailed Summary:
Sponsor: Odense University Hospital

Current Primary Outcome: Pain relief rated on a 0 to 10 point numeric rating scale (median value for last treatment week in each period) [ Time Frame: Daily ]

Original Primary Outcome: Pain relief rated on a 0 to 10 point numeric rating scale (median value for last treatment week in each period)

Current Secondary Outcome:

  • Pain rated on 0 to 10 point numeric rating scales [ Time Frame: Daily ]
  • Pain subtypes rated on 0 to 10 point numeric rating scales [ Time Frame: Daily ]
  • Bruch-evoked pain [ Time Frame: Baseline and end of each treament period ]
  • Pin-prick evoked pain [ Time Frame: Baseline and end of each treatment period ]
  • Cold evoked pain [ Time Frame: Baseline and end of each treatment period ]
  • Health related quality of life(SF-36) [ Time Frame: Baseline and end of each treatment period ]
  • Pain related sleep disturbance [ Time Frame: Daily ]
  • Use of escape medication [ Time Frame: Daily ]


Original Secondary Outcome:

  • Pain rated on 0 to 10 point numeric rating scales
  • Pain subtypes rated on 0 to 10 point numeric rating scales
  • Bruch-evoked pain
  • Pin-prick evoked pain
  • Cold evoked pain
  • Health related quality of life(SF-36)
  • Pain related sleep disturbance
  • Use of escape medication


Information By: Odense University Hospital

Dates:
Date Received: February 1, 2006
Date Started: January 2006
Date Completion:
Last Updated: December 17, 2009
Last Verified: January 2006