Crossover Post-herpetic Neuralgia (PHN)

Completed · Phase 2 · Has a placebo group

Conditions studied: Post-Herpetic Neuralgia (PHN)

In brief

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).

Key facts

Study ID

NCT01305538

Run by

Bristol-Myers Squibb

People needed

100

Starts

2011-03-01

Expected to finish

2012-06-01

Last updated by the study team

2015-12-07

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arizona Research Center — Phoenix, Arizona, United States
• Torrance Clinical Research — Lomita, California, United States
• Alpine Clinical Research Center — Boulder, Colorado, United States
• Brain Matters Research — Delray Beach, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Compass Research, Llc — Orlando, Florida, United States
• Comprehensive Clinical Development, Inc. — St. Petersburg, Florida, United States
• Drug Studies America — Marietta, Georgia, United States
• Commonwealth Biomedical Research, Llc — Madisonville, Kentucky, United States
• Analgesic Solutions — Natick, Massachusetts, United States
• Quest Research Institute — Farmington Hills, Michigan, United States
• The Center For Pharmaceutical Research. Pc — Kansas City, Missouri, United States
• Medex Healthcare Research, Inc — St Louis, Missouri, United States
• Finger Lakes Clinical Research — Rochester, New York, United States
• Wake Research Associates, Llc — Raleigh, North Carolina, United States
• Pmg Research Of Winston-Salem — Winston-Salem, North Carolina, United States
• Radiant Research, Inc. — Akron, Ohio, United States
• Cor Clinical Research — Oklahoma City, Oklahoma, United States
• Futuresearch Trials Of Neurology — Austin, Texas, United States
• Local Institution — Bordeaux, France
• Local Institution — Boulogne-Billancourt, France
• Local Institution — Nice, France
• Local Institution — Saint-Priest-en-Jarez, France

Full record on ClinicalTrials.gov

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