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A 16 Week Study Evaluating Levetiracetam in the Treatment of Post Herpetic Neuralgia (PHN)
This study has been completed.
Sponsored by: UCB
Information provided by: UCB
ClinicalTrials.gov Identifier: NCT00160511
  Purpose

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


Condition Intervention Phase
Neuralgia, Postherpetic
Drug: Levetiracetam
Phase II

MedlinePlus related topics: Shingles
Drug Information available for: Levetiracetam
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Double-Blind, Placebo Control, 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

Further study details as provided by UCB:

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.

Estimated Enrollment: 170
Study Start Date: April 2004
Study Completion Date: September 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00160511

Sponsors and Collaborators
UCB
Investigators
Study Director: F Tonner, MD UCB
  More Information

Study ID Numbers: N01087
Study First Received: September 8, 2005
Last Updated: March 7, 2008
ClinicalTrials.gov Identifier: NCT00160511  
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Neuralgia, Postherpetic
Signs and Symptoms
Neuromuscular Diseases
Neuralgia
Peripheral Nervous System Diseases
Piracetam
Neurologic Manifestations
Etiracetam
Pain

Additional relevant MeSH terms:
Nootropic Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Protective Agents
Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009