A Safety and Effectiveness Study of Intraspinal Gabapentin (MDT2004) for the Treatment of Chronic Pain
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 254
-
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.
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)
Sarasota Pain Medicine Research
🇺🇸Sarasota, Florida, United States
Oregon Health & Science University, Neurosurgery Department
🇺🇸Portland, Oregon, United States
Lifetree Clinical Research
🇺🇸Salt Lake City, Utah, United States
Pinnacle Pain Medicine
🇺🇸Dallas, Texas, United States
Pain Research of Oregon, LLC
🇺🇸Eugene, Oregon, United States
Innovative Spine Care
🇺🇸Little Rock, Arkansas, United States
WK River Cities Clinical Research Center
🇺🇸Shreveport, Louisiana, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
MAPS Applied Research Center
🇺🇸Edina, Minnesota, United States
U B Neurosurgery, Inc.
🇺🇸Buffalo, New York, United States
Lehigh Valley Hospital Center for Pain Management
🇺🇸Allentown, Pennsylvania, United States
Napa Pain Institute
🇺🇸Napa, California, United States
Axis Spine Care/Texas Spine & Joint
🇺🇸Tyler, Texas, United States
The Center for Clinical Research
🇺🇸Winston-Salem, North Carolina, United States