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”

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

Study Type: Interventional

Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment

Study Primary Completion Date: August 2005

Intervention(s) in this Clinical Trial

• Drug: Levetiracetam

Primary 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 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.

Inclusion Criteria:

• male or female outpatient greater than or equal to 18 years of age.
• suffering presently from neuralgia, which has been present for at least 3 months since healing of acute herpes zoster skin rash.
• PHN pain at entry into the study must meet the following criteria: a VAS of at least 40 mm at visit 2 (to assess pain intensity during the past week) and with an average daily score of at least 4 on the PIS during the baseline period as evaluated on a minimum of 4 days.
• an estimated creatinine clearance of at least 50 ml/min.

Exclusion Criteria:

• receiving professional psychological support (such as cognitive behavioral therapy) currently or within 2 weeks prior to visit 1 specifically for coping with PHN.
• previous neurolytic or neurosurgical therapy for PHN, at any time in the subject's history or treatment with TENS (transelectroneuro stimulation) currently or within the past 2 weeks.
• known co-existent source of pain or painful peripheral neuropathy.
• known significant neurological disorder other than the study disease or a condition which can mimic stroke with distal neurological deficit (amyotrophy, radiculopathy, history of TIAs, multiple sclerosis, or any amputations).
• conditions known to be associated with immunosuppressive states.
• clinically significant major depression defined as a Beck Depression Inventory Score >
• 21 at selection including those with a history of Bipolar Disorder.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

F Tonner, MD Study Director UCB  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00160511

Study ID Number: N01087

ClinicalTrials.gov Identifier: NCT00160511

Health Authority: United States: Food and Drug Administration