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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Chronic Intractable Pain

In brief

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.

Key facts

Study ID

NCT00414466

Run by

MedtronicNeuro

People needed

254

Starts

2006-12-01

Expected to finish

2010-08-01

Last updated by the study team

2013-08-23

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Innovative Spine Care — Little Rock, Arkansas, United States
• Napa Pain Institute — Napa, California, United States
• Sarasota Pain Medicine Research — Sarasota, Florida, United States
• WK River Cities Clinical Research Center — Shreveport, Louisiana, United States
• MAPS Applied Research Center — Edina, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• U B Neurosurgery, Inc. — Buffalo, New York, United States
• The Center for Clinical Research — Winston-Salem, North Carolina, United States
• Pain Research of Oregon, LLC — Eugene, Oregon, United States
• Oregon Health & Science University, Neurosurgery Department — Portland, Oregon, United States
• Lehigh Valley Hospital Center for Pain Management — Allentown, Pennsylvania, United States
• Pinnacle Pain Medicine — Dallas, Texas, United States
• Axis Spine Care/Texas Spine & Joint — Tyler, Texas, United States
• Lifetree Clinical Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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