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

Phase 2

Terminated

• Conditions: Chronic Intractable Pain
• Interventions: Drug: Intraspinal Gabapentin

• Registration Number: NCT00414466
• Lead Sponsor: MedtronicNeuro

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-20
• Study First Submitted QC: 2006-12-20
• Study First Posted: 2006-12-21
• Primary Completion: 2009-12
• Study Completion: 2010-08
• Results First Submitted: 2010-12-22
• Results First Submitted QC: 2011-05-06
• Results First Posted: 2011-06-08
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-19
• Last Update Posted: 2013-08-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 254

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (0mg/day)	Intraspinal Gabapentin	Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
Gabapentin Low (1mg/day)	Intraspinal Gabapentin	Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose
Gabapentin Medium (6mg/day)	Intraspinal Gabapentin	Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose
Gabapentin High (30mg/day)	Intraspinal Gabapentin	Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose

Primary Outcome Measures

Name	Time	Method
Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment.	Baseline and Post-randomization Day 22	Average pain score calculated over last 7 days of baseline minus average pain score calculated over last 7 days of follow-up using the Numeric Pain Rating Scale where 0=no pain, 10=worst possible pain.
Number of Participants With Treatment-emergent Adverse Events	Randomization to Post-randomization Day 29 (includes dose reduction)	Evaluation of adverse event profiles between placebo and active treatment groups.

Secondary Outcome Measures

Name	Time	Method
Responder Analysis Between Active Treatment and Placebo Groups.	Baseline to Post-randomization Day 22	Responders were subjects that reported at least a 30% decrease in average daily pain scores between baseline and Day 22.

Trial Locations

Locations (14)

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

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