Neuralgia, Postherpetic Clinical Trial
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
Verified date | September 2009 |
Source | UCB Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
16 week trial assessing the efficacy, safety, and tolerability of levetiracetam compared with placebo in the treatment of postherpetic neuralgia.
Status | Completed |
Enrollment | 170 |
Est. completion date | September 2005 |
Est. primary completion date | August 2005 |
Accepts healthy volunteers | |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
UCB Pharma |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. |
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