Overview
Crossover Post-herpetic Neuralgia (PHN)
Status:
Completed
Completed
Trial end date:
2012-06-01
2012-06-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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).Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Bristol-Myers Squibb
Criteria
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.