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

• Status: Terminated
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedtronicNeuro
• Treatments: Gabapentin; gamma-Aminobutyric Acid

Criteria

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.