NCT00414466

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.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 254 (actual)
• Sponsor: MedtronicNeuro · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Intractable Pain

Interventions

Type	Name	Description
DRUG	Intraspinal Gabapentin	Surgical implantation of a drug infusion system with intrathecal (spinal) delivery of active drug (1 of 3 possible dose levels) or placebo (saline) for 22 days followed by 7 days of infusion at half dose level. Subjects may then continue in open-label treatment with study drug. Dosage in open-label may be adjusted to meet subject needs.

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-12-01
• Completion: 2010-08-01
• First posted: 2006-12-21
• Last updated: 2013-08-23
• Results posted: 2011-06-08

Locations

14 sites across 1 country: United States