Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bristol-Myers Squibb
Allocation: Randomized Stratified; Intervention Model: Cross-over Versus Comparator + Placebo
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | Diabetic Peripheral Neuropathic Pain (DPNP)
