A 16 Week Study Evaluating Levetiracetam in the Treatment of Post Herpetic Neuralgia (PHN)
This study has been completed.
Sponsor:
UCB, Inc.
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00160511
First received: September 8, 2005
Last updated: September 14, 2009
Last verified: September 2009
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Shingles
Drug Information available for:
Levetiracetam
U.S. FDA Resources
Further study details as provided by UCB, Inc.:
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
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00160511 History of Changes |
| Other Study ID Numbers: | N01087 |
| Study First Received: | September 8, 2005 |
| Last Updated: | September 14, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by UCB, Inc.:
|
Postherpetic Neuralgia (PHN) Levetiracetam Keppra Nerve Pain |
Additional relevant MeSH terms:
|
Neuralgia Neuralgia, Postherpetic Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Etiracetam |
Piracetam Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Nootropic Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013