Diabetic Peripheral Neuropathic Pain (DPNP)

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Peripheral Neuropathic Pain

In brief

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).

Key facts

Study ID: NCT01314222
Run by: Bristol-Myers Squibb
People needed: 178
Starts: 2011-03-01
Expected to finish: 2012-07-01
Last updated by the study team: 2015-12-07

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.