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Completed

NCT Number: NCT01314222

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).

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Key information

Conditions

Diabetic Peripheral Neuropathic Pain

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Dijon, France

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-954561

Drug

Pregabalin

Drug

Placebo matching BMS-954561

Drug

Placebo matching Pregabalin

Drug

Primary outcomes

  1. The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo.

    Time frame: Up to 10 weeks

Secondary outcomes

  1. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).

    Time frame: Screening/Baseline Phase: Baseline

  2. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).

    Time frame: Double-blind Treatment Phase: Week 1

  3. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).

    Time frame: Double-blind Treatment Phase: Week 2

  4. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).

    Time frame: Double-blind Treatment Phase: Week 3

  5. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).

    Time frame: Double-blind Treatment Phase: Week 4

  6. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).

    Time frame: Double-blind Treatment Phase: Week 5

  7. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).

    Time frame: Double-blind Treatment Phase: Week 6

  8. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).

    Time frame: Double-blind Treatment Phase: Week 7

  9. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).

    Time frame: Double-blind Treatment Phase: Week 8

  10. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).

    Time frame: Double-blind Treatment Phase: Week 9

  11. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).

    Time frame: Double-blind Treatment Phase: Week 10

  12. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).

    Time frame: Open-Label Phase: Week 2

  13. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).

    Time frame: Open-Label Phase: Week 4

  14. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).

    Time frame: Open-Label Phase: Week 8

  15. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).

    Time frame: Open-Label Phase: Week 12

  16. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).

    Time frame: Open-Label Phase: Week 16

  17. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).

    Time frame: Open-Label Phase: Week 20

  18. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.

    Time frame: Double-blind Treatment Phase: Week 1

  19. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.

    Time frame: Double-blind Treatment Phase: Week 2

  20. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.

    Time frame: Double-blind Treatment Phase: Week 3

  21. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.

    Time frame: Double-blind Treatment Phase: Week 4

  22. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.

    Time frame: Double-blind Treatment Phase: Week 5

  23. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.

    Time frame: Double-blind Treatment Phase: Week 6

  24. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.

    Time frame: Double-blind Treatment Phase: Week 7

  25. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.

    Time frame: Double-blind Treatment Phase: Week 8

  26. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.

    Time frame: Double-blind Treatment Phase: Week 9

  27. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.

    Time frame: Double-blind Treatment Phase: Week 10

  28. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.

    Time frame: Open-Label Phase: Week 2

  29. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.

    Time frame: Open-Label Phase: Week 4

  30. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.

    Time frame: Open-Label Phase: Week 8

  31. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.

    Time frame: Open-Label Phase: Week 12

  32. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.

    Time frame: Open-Label Phase: Week 16

  33. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.

    Time frame: Open-Label Phase: Week 20

  34. 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.

    Time frame: Screening/Baseline Phase: Baseline

  35. 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.

    Time frame: Double-blind Treatment Phase: Week 1

  36. 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.

    Time frame: Double-blind Treatment Phase: Week 2

  37. 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.

    Time frame: Double-blind Treatment Phase: Week 3

  38. 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.

    Time frame: Double-blind Treatment Phase: Week 4

  39. 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.

    Time frame: Double-blind Treatment Phase: Week 5

  40. 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.

    Time frame: Double-blind Treatment Phase: Week 6

  41. 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.

    Time frame: Double-blind Treatment Phase: Week 7

  42. 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.

    Time frame: Double-blind Treatment Phase: Week 8

  43. 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.

    Time frame: Double-blind Treatment Phase: Week 9

  44. 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.

    Time frame: Double-blind Treatment Phase: Week 10

  45. 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.

    Time frame: Open-Label Phase: Week 2

  46. 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.

    Time frame: Open-Label Phase: Week 4

  47. 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.

    Time frame: Open-Label Phase: Week 8

  48. 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.

    Time frame: Open-Label Phase: Week 12

  49. 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.

    Time frame: Open-Label Phase: Week 16

  50. 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.

    Time frame: Open-Label Phase: Week 20

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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)

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 14, 2011
Registry last updated
Dec 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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