Crossover Post-herpetic Neuralgia (PHN)

• Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Screening/Baseline Phase: Baseline ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Weeks 1 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Weeks 2 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Weeks 3 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Weeks 4 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Weeks 5 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Weeks 6 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Weeks 7 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Weeks 8 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Weeks 9 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Weeks 10 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Open-Label Phase: Weeks 2 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Open-Label Phase: Weeks 4 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Open-Label Phase: Weeks 8 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Open-Label Phase: Weeks 12 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Open-Label Phase: Weeks 16 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Open-Label Phase: Weeks 20 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Weeks 1 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Weeks 2 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Weeks 3 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Weeks 4 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Weeks 5 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Weeks 6 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Weeks 7 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Weeks 8 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Weeks 9 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Weeks 10 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Open-Label Phase: Weeks 2 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Open-Label Phase: Weeks 4 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Open-Label Phase: Weeks 8 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Open-Label Phase: Weeks 12 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Open-Label Phase: Weeks 16 ] [ Designated as safety issue: No ]
• Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Open-Label Phase: Weeks 20 ] [ Designated as safety issue: No ]
• Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Screening/Baseline Phase: Baseline ] [ Designated as safety issue: Yes ]
• Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Double-blind Treatment Phase: Weeks 1 ] [ Designated as safety issue: Yes ]
• Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Double-blind Treatment Phase: Weeks 2 ] [ Designated as safety issue: Yes ]
• Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Double-blind Treatment Phase: Weeks 3 ] [ Designated as safety issue: Yes ]
• Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Double-blind Treatment Phase: Weeks 4 ] [ Designated as safety issue: Yes ]
• Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Double-blind Treatment Phase: Weeks 5 ] [ Designated as safety issue: Yes ]
• Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Double-blind Treatment Phase: Weeks 6 ] [ Designated as safety issue: Yes ]
• Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Double-blind Treatment Phase: Weeks 7 ] [ Designated as safety issue: Yes ]
• Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Double-blind Treatment Phase: Weeks 8 ] [ Designated as safety issue: Yes ]
• Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Double-blind Treatment Phase: Weeks 9 ] [ Designated as safety issue: Yes ]
• Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Double-blind Treatment Phase: Weeks 10 ] [ Designated as safety issue: Yes ]
• Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Open-Label Phase: Weeks 2 ] [ Designated as safety issue: Yes ]
• Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Open-Label Phase: Weeks 4 ] [ Designated as safety issue: Yes ]
• Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Open-Label Phase: Weeks 8 ] [ Designated as safety issue: Yes ]
• Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Open-Label Phase: Weeks 12 ] [ Designated as safety issue: Yes ]
• Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Open-Label Phase: Weeks 16 ] [ Designated as safety issue: Yes ]
• Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Open-Label Phase: Weeks 20 ] [ Designated as safety issue: Yes ]

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

• Drug: BMS-954561
  Capsule, Oral, 40mg or 80mg, Three times daily (TID), 10 weeks (double-blind) + 20 weeks (open-label BMS-954561)
  Other Name: BMS-954561
• Drug: BMS-954561
  Capsule, Oral, 150mg or 300 mg, Three times daily (TID), 10 weeks (double-blind) + 20 weeks (open-label BMS-954561)
  Other Name: BMS-954561
• Drug: Placebo
  Capsule, Oral, 0.0 mg, Three times daily (TID), 10 weeks (double-blind) + 20 weeks (open-label)

• Arm 1 BMS-954561 40mg or 80mg

  Arm description: BMS-954561 40mg or 80mg three times daily (TID) to Placebo OR Placebo to 40mg or 80mg TID.

  Arm type: Active to Placebo or Placebo to Active (cross-over)

  Interventions:

  • Drug: BMS-954561
  • Drug: Placebo
• Arm 2 BMS-954561 150mg or 300mg

  Arm description: BMS-954561 150mg or 300mg TID to Placebo OR Placebo to 150mg or 300mg TID

  Arm type: Active to Placebo or Placebo to Active(cross-over)

  Interventions:

  • Drug: BMS-954561
  • Drug: Placebo

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.