Diabetic Peripheral Neuropathic Pain (DPNP)

NCT01314222 | Completed Phase 2

• 2 other identifiers: CN169-0012010-023042-70
• Study Type: interventional
• Target: 178
• Locations: 2 countries
• Sites: 24

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).

Conditions

Diabetic Peripheral Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

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

  Up to 10 weeks

Secondary Outcomes (50)

• 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 using the Brief Pain Inventory-short form (BPI-SF).

  Double-blind Treatment Phase: Week 1

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

  Double-blind Treatment Phase: Week 2

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

  Double-blind Treatment Phase: Week 3

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

  Double-blind Treatment Phase: Week 4

Study Arms (3)

Arm 1: BMS-954561 40mg or 80mg

OTHER

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

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

Arm 2: BMS-954561 150mg or 300mg

OTHER

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

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

Arm 3: Pregabalin 100mg

OTHER

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

Drug: Pregabalin; Drug: Placebo matching Pregabalin

Interventions

BMS-954561 DRUG

Arm 1: BMS-954561 40mg or 80mg; Arm 2: BMS-954561 150mg or 300mg

Pregabalin DRUG

Arm 3: Pregabalin 100mg

Placebo matching BMS-954561 DRUG

Arm 1: BMS-954561 40mg or 80mg; Arm 2: BMS-954561 150mg or 300mg

Placebo matching Pregabalin DRUG

Arm 3: Pregabalin 100mg

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (24)

Achieve Clinical Research, Llc

Birmingham, Alabama, 35216, United States

Location

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Torrance Clinical Research

Lomita, California, 90717, United States

Location

Office Of Richard S. Cherlin, Md

Los Gatos, California, 95032, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Brain Matters Research

Delray Beach, Florida, 33445, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Compass Research, Llc

Orlando, Florida, 32806, United States

Location

Comprehensive Clinical Development, Inc.

St. Petersburg, Florida, 33716, United States

Location

Northwest Neurology Ltd.

Lake Barrington, Illinois, 60010, United States

Location

Commonwealth Biomedical Research, Llc

Madisonville, Kentucky, 42431, United States

Location

The Center For Pharmaceutical Research. Pc

Kansas City, Missouri, 64114, United States

Location

Mercy Health Research

St Louis, Missouri, 63141, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

Physicians East P.A.

Greenville, North Carolina, 27834, United States

Location

Pmg Research Of Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Radiant Research, Inc.

Akron, Ohio, 44311, United States

Location

Neurology & Neuroscience Center Of Ohio

Toledo, Ohio, 43623, United States

Location

Clinical Research Associates, Inc.

Nashville, Tennessee, 37203, United States

Location

Dallas Diabetes & Endocrine Center

Dallas, Texas, 75230, United States

Location

R/D Clinical Research, Inc.

Lake Jackson, Texas, 77566, United States

Location

Local Institution

Dijon, 21079, France

Location

Local Institution

Nantes, 44093, France

Location

Local Institution

Nice, 06003, France

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2011
• First Posted: March 14, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: July 1, 2012
• Last Updated: December 7, 2015

Record last verified: 2015-11

Locations

US (21); FR (3)