Diabetic Peripheral Neuropathic Pain (DPNP)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Diabetic Peripheral Neuropathic Pain

Treatments: Drug: Pregabalin; Drug: Placebo matching BMS-954561; Drug: BMS-954561; Drug: Placebo matching Pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01314222

CN169-001

2010-023042-70 (EudraCT Number)

Details and patient eligibility

About

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).

Full description

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

Enrollment: 178 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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178 participants in 3 patient groups

Arm 1: BMS-954561 40mg or 80mg

Other group

Description:

BMS-954561 40mg or 80mg TID to Placebo OR Placebo to 40mg or 80mg TID Active to Placebo or Placebo to Active (cross-over)

Treatment:

Drug: Placebo matching BMS-954561

Drug: BMS-954561

Arm 2: BMS-954561 150mg or 300mg

Other group

Description:

BMS-954561 150mg or 300mg TID to Placebo OR Placebo to 150mg or 300mg TID Active to Placebo or Placebo to Active (cross-over)

Treatment:

Drug: Placebo matching BMS-954561

Drug: BMS-954561

Arm 3: Pregabalin 100mg

Other group

Description:

Pregabalin 100mg TID to Placebo OR Placebo to 100mg TID Active to Placebo or Placebo to Active (cross-over)

Treatment:

Drug: Pregabalin

Drug: Placebo matching Pregabalin