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)
Overview
- Phase
- Phase 2
- Intervention
- BMS-954561
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 178
- Locations
- 22
- Primary Endpoint
- The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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 diabetic peripheral neuropathic pain (DPNP).
Detailed Description
Allocation: Randomized Stratified; Intervention Model: Cross-over Versus Comparator + Placebo
Investigators
Eligibility Criteria
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.
Arms & Interventions
Arm 1: BMS-954561 40mg or 80mg
BMS-954561 40mg or 80mg TID to Placebo OR Placebo to 40mg or 80mg TID Active to Placebo or Placebo to Active (cross-over)
Intervention: BMS-954561
Arm 1: BMS-954561 40mg or 80mg
BMS-954561 40mg or 80mg TID to Placebo OR Placebo to 40mg or 80mg TID Active to Placebo or Placebo to Active (cross-over)
Intervention: Placebo matching BMS-954561
Arm 2: BMS-954561 150mg or 300mg
BMS-954561 150mg or 300mg TID to Placebo OR Placebo to 150mg or 300mg TID Active to Placebo or Placebo to Active (cross-over)
Intervention: BMS-954561
Arm 2: BMS-954561 150mg or 300mg
BMS-954561 150mg or 300mg TID to Placebo OR Placebo to 150mg or 300mg TID Active to Placebo or Placebo to Active (cross-over)
Intervention: Placebo matching BMS-954561
Arm 3: Pregabalin 100mg
Pregabalin 100mg TID to Placebo OR Placebo to 100mg TID Active to Placebo or Placebo to Active (cross-over)
Intervention: Pregabalin
Arm 3: Pregabalin 100mg
Pregabalin 100mg TID to Placebo OR Placebo to 100mg TID Active to Placebo or Placebo to Active (cross-over)
Intervention: Placebo matching Pregabalin
Outcomes
Primary Outcomes
The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo.
Time Frame: Up to 10 weeks
Secondary Outcomes
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).(Open-Label Phase: Week 20)
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.(Open-Label Phase: Week 20)
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.(Open-Label Phase: Week 20)