- Patients require a diagnosis of post-traumatic peripheral neuropathic pain (NeP),
including post-surgical NeP and NeP due to peripheral nerve injury, which has lasted
at least 3 months following the traumatic event.
- Patients during the screening week must have completed ≥ 4 daily pain scores and have
an average daily pain score ≥ 4.
- Female patients of childbearing potential must have a negative urine pregnancy test at
Screening and be practicing an acceptable form of contraception.
- Patients with neuropathic pain (NeP) that is not due to trauma; e.g. patients with
trigeminal neuralgia, central pain, complex region pain syndrome type I, phantom limb
pain, radiculopathy, painful diabetic neuropathy or post-herpetic neuralgia or
patients with any other co-existing pain which cannot be differentiate from NeP of
peripheral origin.
- Patients who have previously failed to respond to pregabalin at a total daily dose of
equal to or greater than 300 mg or are intolerant to those doses.
- Patients who have previously failed to respond to gabapentin at a total daily dose of
equal to or greater than 1800 mg.
- Patients with any type or history of malignancy, except either where there has been no
ongoing treatment for at least 6 months or all basal cell carcinomas; all patients
with a history of brain or spinal tumors will be excluded.
- Patients who currently have ongoing litigation related to any injury affecting their
pain symptomatology.