Diabetic Peripheral Neuropathic Pain
Conditions
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
Interventions
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo. | Up to 10 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). | Screening/Baseline Phase: Baseline |
| Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. | Double-blind Treatment Phase: Week 1 |
| 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. | Screening/Baseline Phase: Baseline |
Countries
France, United States
Outcome results
None listed