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).
Drug: Placebo matching BMS-954561
Drug: Placebo matching Pregabalin
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01314222
Ages eligible for Study
18 Years to 85 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.
All locations for NCT01314222
United States (21)
Birmingham, Alabama, United States, 35216
Arizona Research Center
Phoenix, Arizona, United States, 85023
Torrance Clinical Research
Lomita, California, United States, 90717
Office Of Richard S. Cherlin, Md
Los Gatos, California, United States, 95032
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
Brain Matters Research
Delray Beach, Florida, United States, 33445
Renstar Medical Research
Ocala, Florida, United States, 34471
Compass Research, Llc
Orlando, Florida, United States, 32806
Comprehensive Clinical Development, Inc.
St Petersburg, Florida, United States, 33716
Northwest Neurology Ltd.
Lake Barrington, Illinois, United States, 60010
Commonwealth Biomedical Research, Llc
Madisonville, Kentucky, United States, 42431
The Center For Pharmaceutical Research. Pc
Kansas City, Missouri, United States, 64114
Mercy Health Research
St. Louis, Missouri, United States, 63141
Finger Lakes Clinical Research
Rochester, New York, United States, 14618
Physicians East P.A.
Greenville, North Carolina, United States, 27834
Pmg Research Of Winston-Salem
Winston-Salem, North Carolina, United States, 27103
Radiant Research, Inc.
Akron, Ohio, United States, 44311
Neurology & Neuroscience Center Of Ohio
Toledo, Ohio, United States, 43623
Clinical Research Associates, Inc.
Nashville, Tennessee, United States, 37203
Dallas Diabetes & Endocrine Center
Dallas, Texas, United States, 75230
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States, 77566
Dijon Cedex, France, 21079
Nantes Cedex 1, France, 44093
Nice Cedex 1, France, 06003
View full eligibility
Tris trial is registered with FDA with number: NCT01314222. The sponsor of the trial is Bristol-Myers Squibb and it is looking for 178 volunteers for the current phase.
Official trial 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)
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