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

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

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 Type : Interventional  (Clinical Trial)
Estimated 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
Primary Completion Date : August 2005
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles
U.S. FDA Resources

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.

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00160511

Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center UCB Pharma

Additional Information:
ClinicalTrials.gov Identifier: NCT00160511     History of Changes
Other Study ID Numbers: N01087
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: September 2009

Keywords provided by UCB Pharma:
Postherpetic Neuralgia (PHN)
Nerve Pain

Additional relevant MeSH terms:
Neuralgia, Postherpetic
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs