- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00160511
A 16 Week Study Evaluating Levetiracetam in the Treatment of Post Herpetic Neuralgia (PHN)
November 25, 2013 updated by: UCB Pharma
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
16 week trial assessing the efficacy, safety, and tolerability of levetiracetam compared with placebo in the treatment of postherpetic neuralgia.
Study Overview
Study Type
Interventional
Enrollment
170
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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
Outcome Measure |
---|
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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2004
Primary Completion (ACTUAL)
August 1, 2005
Study Completion (ACTUAL)
September 1, 2005
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 8, 2005
First Posted (ESTIMATE)
September 12, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
November 26, 2013
Last Update Submitted That Met QC Criteria
November 25, 2013
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N01087
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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