Clinical Trial: A 16 Week Study Evaluating Levetiracetam in the Treatment of Post Herpetic Neuralgia (PHN)

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

Official Title: A Double-blind, Randomized, Placebo-controlled, Parallel-group, 16 Week, Multicenter Trial Evaluating the Efficacy and Safety of Levetiracetam 500 mg Tablets in Bid Administration (Daily Dose Ranging

Brief Summary: 16 week trial assessing the efficacy, safety, and tolerability of levetiracetam compared with placebo in the treatment of postherpetic neuralgia.

Detailed Summary:
Sponsor: UCB Pharma

Current Primary Outcome: Assess efficacy of levetiracetam in the treatment of Post Herpetic Neuralgia by measuring the absolute change in the average weekly Pain Intensity Scale (PIS).

Original Primary Outcome: To assess efficacy of levetiracetam in the treatment of Post Herpetic Neuralgia by measuring the absolute change in the average weekly Pain Intensity Scale (PIS) from the baseline period to the last 7 days of the evaluation period

Current Secondary Outcome: Assess the efficacy, safety and tolerability of levetiracetam in the treatment of Post Herpetic Neuralgia; Reduction in the mean PIS over the last week of the evaluation period compared to the baseline period.

Original Secondary Outcome:

  • • To assess the efficacy, safety and tolerability of levetiracetam in the treatment of Post Herpetic Neuralgia by measuring :
  • • Reduction of at least 30%/50% in the mean PIS over the last week of the evaluation period compared to the baseline period (30%/50% Responder).
  • • Percent change in the mean PIS from the baseline week to each weekly mean.
  • • Changes from the baseline week to each weekly mean, and to the last week of evaluation period, in the SIS.
  • • Absolute changes from the randomization visit to each evaluation period/early discontinuation visit, in each score of the SF-MPQ.


Information By: UCB Pharma

Dates:
Date Received: September 8, 2005
Date Started: April 2004
Date Completion:
Last Updated: November 25, 2013
Last Verified: September 2009