Back to resultsA Safety and Effectiveness Study of Intraspinal Gabapentin (MDT2004) for the Treatment of Chronic Pain
Primary Purpose
Chronic Intractable Pain
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intraspinal Gabapentin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Intractable Pain
Eligibility 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.
Sites / Locations
- Innovative Spine Care
- Napa Pain Institute
- Sarasota Pain Medicine Research
- WK River Cities Clinical Research Center
- MAPS Applied Research Center
- Mayo Clinic
- U B Neurosurgery, Inc.
- The Center for Clinical Research
- Pain Research of Oregon, LLC
- Oregon Health & Science University, Neurosurgery Department
- Lehigh Valley Hospital Center for Pain Management
- Pinnacle Pain Medicine
- Axis Spine Care/Texas Spine & Joint
- Lifetree Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Placebo (0mg/day)
Gabapentin Low (1mg/day)
Gabapentin Medium (6mg/day)
Gabapentin High (30mg/day)
Arm Description
Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose
Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose
Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose
Outcomes
Primary Outcome Measures
Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment.
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
Evaluation of adverse event profiles between placebo and active treatment groups.
Secondary Outcome Measures
Responder Analysis Between Active Treatment and Placebo Groups.
Responders were subjects that reported at least a 30% decrease in average daily pain scores between baseline and Day 22.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00414466
Brief Title
A Safety and Effectiveness Study of Intraspinal Gabapentin (MDT2004) for the Treatment of Chronic Pain
Official Title
A Randomized Double Blind, Placebo-controlled, Dose Response Study of Intraspinal Gabapentin (MDT2004) in Subjects With Chronic, Intractable Pain.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Why Stopped
Study closed and subject follow-up completed following analysis of blinded study data.
Study Start Date
December 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedtronicNeuro
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Intractable Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
254 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo (0mg/day)
Arm Type
Placebo Comparator
Arm Description
Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
Arm Title
Gabapentin Low (1mg/day)
Arm Type
Active Comparator
Arm Description
Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose
Arm Title
Gabapentin Medium (6mg/day)
Arm Type
Active Comparator
Arm Description
Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose
Arm Title
Gabapentin High (30mg/day)
Arm Type
Active Comparator
Arm Description
Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose
Intervention Type
Drug
Intervention Name(s)
Intraspinal Gabapentin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment.
Description
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.
Time Frame
Baseline and Post-randomization Day 22
Title
Number of Participants With Treatment-emergent Adverse Events
Description
Evaluation of adverse event profiles between placebo and active treatment groups.
Time Frame
Randomization to Post-randomization Day 29 (includes dose reduction)
Secondary Outcome Measure Information:
Title
Responder Analysis Between Active Treatment and Placebo Groups.
Description
Responders were subjects that reported at least a 30% decrease in average daily pain scores between baseline and Day 22.
Time Frame
Baseline to Post-randomization Day 22
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Innovative Spine Care
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Napa Pain Institute
City
Napa
State/Province
California
ZIP/Postal Code
94558
Country
United States
Facility Name
Sarasota Pain Medicine Research
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34238
Country
United States
Facility Name
WK River Cities Clinical Research Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
MAPS Applied Research Center
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
U B Neurosurgery, Inc.
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
The Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Pain Research of Oregon, LLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Oregon Health & Science University, Neurosurgery Department
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Lehigh Valley Hospital Center for Pain Management
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Pinnacle Pain Medicine
City
Dallas
State/Province
Texas
ZIP/Postal Code
75240
Country
United States
Facility Name
Axis Spine Care/Texas Spine & Joint
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Lifetree Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23835590
Citation
Rauck R, Coffey RJ, Schultz DM, Wallace MS, Webster LR, McCarville SE, Grigsby EJ, Page LM. Intrathecal gabapentin to treat chronic intractable noncancer pain. Anesthesiology. 2013 Sep;119(3):675-86. doi: 10.1097/ALN.0b013e3182a10fbf.
Results Reference
derived
Learn more about this trial
A Safety and Effectiveness Study of Intraspinal Gabapentin (MDT2004) for the Treatment of Chronic Pain
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