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

• ClinicalTrials.gov Identifier: NCT00160511
• Recruitment Status: Completed
• First Posted: September 12, 2005
• Last Update Posted: November 26, 2013
• Sponsor: UCB Pharma
• Information provided by: UCB Pharma

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Neuralgia, Postherpetic	Drug: Levetiracetam	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 170 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• 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
• Study Start Date: April 2004
• Actual Primary Completion Date: August 2005
• Actual Study Completion Date: September 2005

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

UCB Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center; UCB Pharma

More Information

• ClinicalTrials.gov Identifier: NCT00160511
• Other Study ID Numbers: N01087
• First Posted: September 12, 2005
• Last Update Posted: November 26, 2013
• Last Verified: September 2009

Keywords provided by UCB Pharma:

Postherpetic Neuralgia (PHN); Levetiracetam; Keppra; Nerve Pain

Additional relevant MeSH terms:

Neuralgia; Neuralgia, Postherpetic; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Levetiracetam; Anticonvulsants; Nootropic Agents