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

NCT00160511 | Completed Phase 2

• 1 other identifier: N01087
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Neuralgia, Postherpetic

Keywords

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

Outcome Measures

Primary Outcomes (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 Outcomes (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.

Interventions

Levetiracetam DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UCB Pharma: lead

MeSH Terms

Conditions

Neuralgia, Postherpetic; Neuralgia

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• UCB Clinical Trial Call Center

  UCB Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: April 1, 2004
• Primary Completion: August 1, 2005
• Study Completion: September 1, 2005
• Last Updated: November 26, 2013

Record last verified: 2009-09