Crossover Post-herpetic Neuralgia (PHN)



Status:Completed
Conditions:Postherpatic Neuralgia
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 85
Updated:4/21/2016
Start Date:March 2011
End Date:June 2012

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A Randomized, Multicenter, Double-blind, Placebo-controlled, Cross-over Study of the Efficacy and Safety of BMS-954561 in Patients With Post-herpetic Neuralgia (PHN)

The purpose of the study is to evaluate the efficacy of study drug (BMS-954561) as compared
to placebo in the treatment of patients with post-herpetic neuralgia (PHN).

Allocation: Randomized Stratified

Interventional model: Cross-over Placebo Controlled

Inclusion Criteria:

- Patient with Post-Herpetic Neuralgia (PHN) as defined as pain present for more than 6
months after the onset of a herpes zoster skin rash affecting the trigeminal,
cervical, thoracic, lumbar, or sacral regions.

- Based on patient diary information collected during the Baseline week (day -7 to
randomization Day 1), patient has completed at least 5 diary entries and has an
average weekly pain rating of at least 4 on the 11-point pain rating scale.

- The patient is able to satisfactorily complete, in the Investigator's judgment, the
Cognitive Battery.

- Male or female, 18-85 years of age.

Exclusion Criteria:

- Other severe pain that may potentially confound pain assessment.

- History of complete lack of response to pregabalin (at least 300 mg qd for 4 weeks)
or gabapentin (at least 1800 mg qd for 4 weeks).

- Hemoglobin A1c > 9%

- Hemoglobin ≤ 9 g/dL.

- Active herpes zoster or known viral infection.

- Previous neurolytic or neurosurgical therapy for PHN.

- Estimated glomerular filtration rate (eGFR) according to the re-expressed abbreviated
(four-variable) Modification of Diet in Renal Disease (MDRD) Study equation ≤
40ml/min/1.73m2.

- Patients who have been on a stable dose of anticonvulsant,anticholinergic, antiviral
medications, nicotine replacements, or any other smoking cessation medications for <4
weeks prior to randomization. Patients who are on stable doses for => 4 weeks prior
to randomization are allowed, however, there should be no adjustments to the dose of
these medications during study.

- Patients currently on more than one drug for treatment of neuropathic pain (low dose
opioids, antidepressants, or anticonvulsants). Patients are allowed to participate if
on a stable dose for at least 4 weeks prior to randomization (Day1) and should remain
stable during course of study.
We found this trial at
20
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Bordeaux Cedex, 33076
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1000 Alpine
Boulder, Colorado 80304
303-443-7229
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Boulder, CO
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240 East Ayr Parkway
Madisonville, Kentucky 42431
888-569-8930
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Madisonville, KY
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400 Tower Rd Ne
Marietta, Georgia 30060
678-581-5252
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Marietta, GA
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104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
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Ocala, FL
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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Orlando, FL
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Akron, Ohio 44311
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Austin, Texas 78703
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Delray Beach, Florida 33445
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Farmington Hills, Michigan 48334
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Kansas City, Missouri 64114
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Lomita, California 90717
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Natick, Massachusetts 01760
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Natick, MA
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Oklahoma City, Oklahoma 73103
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Phoenix, Arizona 85023
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Rochester, New York 14618
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St Petersburg, Florida 33716
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St. Louis, Missouri 63117
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1901 S Hawthorne Rd #306
Winston-Salem, North Carolina 27103
(336) 768-8062
PMG Research of Winston-Salem PMG Research of Winston-Salem, founded in 1979, occupies a 10,000 square...
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