- Diagnosis of diabetes mellitus (high blood sugar) with HbA1c levels of ≤11% at
Screening, and on a stable anti-diabetic medication regimen for the 30 days prior to
- Diagnosis of diabetic peripheral neuropathy pain in the legs or feet with decreased
sensation in the feet or decreased/absent ankle jerk/ reflexes.
- Presence of ongoing pain due to diabetic peripheral neuropathy for at least 3 months.
- A pain score of greater than or equal to (≥) 4 for from diabetic peripheral neuropathy
on the Numerical Rating Scale (NRS), a 11-point scale with 0 meaning no pain and 10
meaning worst pain at Screening.
- Be willing to stop all pain medications for diabetic peripheral neuropathy except for
the limited use of acetaminophen (Tylenol) or ibuprofen-like (Motrin) medications
between Screening and Baseline and not use prohibited pain medications throughout the
duration of the study except as permitted by the study guidelines.
- Painful neuropathies other than diabetic peripheral neuropathy.
- Other types of diabetic neuropathies.
- Patients with a past history of carpal tunnel syndrome (CTS) with signs or symptoms of
CTS in the one year prior to Screening are not eligible for participation.
- Patients with fibromyalgia, regional pain caused by lumbar or cervical compression
with radiculopathy or other moderate to severe pain.
- Patients with a present (current) history of sciatica are not eligible for
- The presence of pain conditions that cannot be distinguished from diabetic peripheral
neuropathy such as peripheral vascular disease.
- Amputations dues to diabetes.
- Patient with any clinically significant medical condition or laboratory abnormalities.
- History, diagnosis, or signs and symptoms of clinically significant neurological
diseases (such as Alzheimer's disease, head trauma, epilepsy or stroke).
- History, diagnosis, or signs and symptoms of clinically significant psychiatric
diseases (such as bipolar disorder or schizophrenia).
- History of known alcohol, analgesic or drug abuse within 2 years of Screening.
- Pregnant women, lactating mothers, women suspected of being pregnant, and women who
wish to be pregnant during the course of clinical study.