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

PHASE2TerminatedINTERVENTIONAL
Enrollment

254

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

December 31, 2009

Study Completion Date

August 31, 2010

Conditions
Chronic Intractable Pain
Interventions
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.

Trial Locations (14)

14203

U B Neurosurgery, Inc., Buffalo

18103

Lehigh Valley Hospital Center for Pain Management, Allentown

27103

The Center for Clinical Research, Winston-Salem

34238

Sarasota Pain Medicine Research, Sarasota

55435

MAPS Applied Research Center, Edina

55905

Mayo Clinic, Rochester

71105

WK River Cities Clinical Research Center, Shreveport

72205

Innovative Spine Care, Little Rock

75240

Pinnacle Pain Medicine, Dallas

75701

Axis Spine Care/Texas Spine & Joint, Tyler

84106

Lifetree Clinical Research, Salt Lake City

94558

Napa Pain Institute, Napa

97201

Oregon Health & Science University, Neurosurgery Department, Portland

97401

Pain Research of Oregon, LLC, Eugene

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MedtronicNeuro

INDUSTRY