Diabetic Peripheral Neuropathic Pain (DPNP)

A Randomized, Multicenter, Double-blind, Placebo and Active-controlled, Cross-over Study of the Efficacy and Safety of BMS-954561 in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

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 diabetic peripheral neuropathic pain (DPNP).

Allocation: Randomized Stratified; Intervention Model: Cross-over Versus Comparator + Placebo

Inclusion Criteria:

• Type I or Type II diabetes with painful, distal, symmetrical, sensory-motor neuropathy attributed to diabetes, of at least 6 months duration.
• Score of ≥3 on Michigan Neuropathy Screening Instrument
• The patient is able to satisfactorily complete, in the Investigator's judgment, the Cognitive Battery.
• Based on patient diary information collected during the Screening/Baseline period, the patient has completed at least 5 of 7 daily diary entries and has an average weekly pain rating of at least 4 on the 11-point pain rating scale, in the week immediately prior to randomization (Baseline Visit).
• Male or female, 18-85 years of age.

Exclusion Criteria:

• 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).
• Other severe pain that may potentially confound pain assessment.
• Hemoglobin A1c > 9%
• Hemoglobin ≤ 9 g/dL
• Estimated glomerular filtration rate (eGFR) according to the re-expressed abbreviated (four-variable) Modification of Diet in Renal Disease (MDRD) Study equation ≤ 50ml/min/1.73m2
• Patients who have been on a stable dose of anticonvulsant, anticholinergic, diabetic meds, nicotine replacements, or any other smoking cessation meds 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 or antidepressants). Patients are allowed to participate if on a stable dose of for at least 4 weeks prior to randomization (Day1) and should remain stable during study.