Diabetic Peripheral Neuropathic Pain (DPNP)

Phase 2

Completed

Conditions: Diabetic Peripheral Neuropathic Pain

Interventions: Drug: BMS-954561
Drug: Pregabalin
Drug: Placebo matching Pregabalin
Drug: Placebo matching BMS-954561

Registration Number: NCT01314222

Lead Sponsor: Bristol-Myers Squibb

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 178

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 3: Pregabalin 100mg	Placebo matching Pregabalin	Pregabalin 100mg TID to Placebo OR Placebo to 100mg TID Active to Placebo or Placebo to Active (cross-over)
Arm 1: BMS-954561 40mg or 80mg	BMS-954561	BMS-954561 40mg or 80mg TID to Placebo OR Placebo to 40mg or 80mg TID Active to Placebo or Placebo to Active (cross-over)
Arm 3: Pregabalin 100mg	Pregabalin	Pregabalin 100mg TID to Placebo OR Placebo to 100mg TID Active to Placebo or Placebo to Active (cross-over)
Arm 1: BMS-954561 40mg or 80mg	Placebo matching BMS-954561	BMS-954561 40mg or 80mg TID to Placebo OR Placebo to 40mg or 80mg TID Active to Placebo or Placebo to Active (cross-over)
Arm 2: BMS-954561 150mg or 300mg	Placebo matching BMS-954561	BMS-954561 150mg or 300mg TID to Placebo OR Placebo to 150mg or 300mg TID Active to Placebo or Placebo to Active (cross-over)
Arm 2: BMS-954561 150mg or 300mg	BMS-954561	BMS-954561 150mg or 300mg TID to Placebo OR Placebo to 150mg or 300mg TID Active to Placebo or Placebo to Active (cross-over)

Primary Outcome Measures

Name	Time	Method
The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo.	Up to 10 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (22): Comprehensive Clinical Development, Inc.
🇺🇸
St Petersburg, Florida, United States
Local Institution
🇫🇷
Nice Cedex 1, France
Office Of Richard S. Cherlin, Md
🇺🇸
Los Gatos, California, United States
Finger Lakes Clinical Research
🇺🇸
Rochester, New York, United States
Arizona Research Center
🇺🇸
Phoenix, Arizona, United States
Brain Matters Research
🇺🇸
Delray Beach, Florida, United States
Clinical Research Associates, Inc.
🇺🇸
Nashville, Tennessee, United States
Renstar Medical Research
🇺🇸
Ocala, Florida, United States
Achieve Clinical Research, Llc
🇺🇸
Birmingham, Alabama, United States
Compass Research, Llc
🇺🇸
Orlando, Florida, United States
Pmg Research Of Winston-Salem
🇺🇸
Winston-Salem, North Carolina, United States
Torrance Clinical Research
🇺🇸
Lomita, California, United States
Diablo Clinical Research, Inc.
🇺🇸
Walnut Creek, California, United States
Commonwealth Biomedical Research, Llc
🇺🇸
Madisonville, Kentucky, United States
Northwest Neurology Ltd.
🇺🇸
Lake Barrington, Illinois, United States
Mercy Health Research
🇺🇸
St. Louis, Missouri, United States
Radiant Research, Inc.
🇺🇸
Akron, Ohio, United States
Physicians East P.A.
🇺🇸
Greenville, North Carolina, United States
Neurology & Neuroscience Center Of Ohio
🇺🇸
Toledo, Ohio, United States
R/D Clinical Research, Inc.
🇺🇸
Lake Jackson, Texas, United States
Dallas Diabetes & Endocrine Center
🇺🇸
Dallas, Texas, United States
The Center For Pharmaceutical Research. Pc
🇺🇸
Kansas City, Missouri, United States