A 16 Week Study Evaluating Levetiracetam in the Treatment of Post Herpetic Neuralgia (PHN)
This study has been completed.
Information provided by:
First received: September 8, 2005
Last updated: September 14, 2009
Last verified: September 2009
16 week trial assessing the efficacy, safety, and tolerability of levetiracetam compared with placebo in the treatment of postherpetic neuralgia.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
|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 From 1000 mg to 3000 mg), in Adults (≥ 18 Years of Age) Suffering From Postherpetic Neuralgia|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- Assess efficacy of levetiracetam in the treatment of Post Herpetic Neuralgia by measuring the absolute change in the average weekly Pain Intensity Scale (PIS).
Secondary Outcome Measures:
- 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.
|Study Start Date:||April 2004|
|Study Completion Date:||September 2005|
|Primary Completion Date:||August 2005 (Final data collection date for primary outcome measure)|
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