Status:
COMPLETED
A 16 Week Study Evaluating Levetiracetam in the Treatment of Post Herpetic Neuralgia (PHN)
Lead Sponsor:
UCB Pharma
Conditions:
Neuralgia, Postherpetic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
16 week trial assessing the efficacy, safety, and tolerability of levetiracetam compared with placebo in the treatment of postherpetic neuralgia.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00160511
Start Date
April 1 2004
End Date
September 1 2005
Last Update
November 26 2013
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