A Safety and Effectiveness Study of Intraspinal Gabapentin (MDT2004) for the Treatment of Chronic Pain

A Randomized Double Blind, Placebo-controlled, Dose Response Study of Intraspinal Gabapentin (MDT2004) in Subjects With Chronic, Intractable Pain.

The purpose of this study is to determine the safety and minimum effective dose of intraspinal gabapentin when delivered through an implanted drug infusion system.

Inclusion Criteria:

• Chronic pain below the neck present for a minimum of one year.

• Diagnosis of at least one of the following:

  • back pain with or without leg pain,
  • post-herpetic neuralgia,
  • complex regional pain syndrome (CRPS) 1 or 2,
  • diabetic neuropathy,
  • or a general neuropathic condition; medically stable and able to undergo surgery for implantation of the drug infusion system.