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

A Randomized Double Blind, Placebo-controlled, Dose Response Study of Intraspinal Gabapentin (MDT2004) in Subjects With Chronic, Intractable Pain.

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Intractable Pain
• Intervention / Treatment: Drug: Intraspinal Gabapentin

• Study Type: Interventional
• Enrollment (Actual): 254
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Innovative Spine Care
  • California
    • Napa, California, United States, 94558
      • Napa Pain Institute
  • Florida
    • Sarasota, Florida, United States, 34238
      • Sarasota Pain Medicine Research
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • WK River Cities Clinical Research Center
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • MAPS Applied Research Center
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • Buffalo, New York, United States, 14203
      • U B Neurosurgery, Inc.
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Pain Research of Oregon, LLC
    • Portland, Oregon, United States, 97201
      • Oregon Health & Science University, Neurosurgery Department
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital Center for Pain Management
  • Texas
    • Dallas, Texas, United States, 75240
      • Pinnacle Pain Medicine
    • Tyler, Texas, United States, 75701
      • Axis Spine Care/Texas Spine & Joint
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Lifetree Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo (0mg/day); Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system	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.
Active Comparator: Gabapentin Low (1mg/day); Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose	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.
Active Comparator: Gabapentin Medium (6mg/day); Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose	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.
Active Comparator: Gabapentin High (30mg/day); Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Post-randomization Day 22
Number of Participants With Treatment-emergent Adverse Events	Evaluation of adverse event profiles between placebo and active treatment groups.	Randomization to Post-randomization Day 29 (includes dose reduction)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to Post-randomization Day 22

Collaborators and Investigators

• Sponsor: MedtronicNeuro

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: December 20, 2006
• First Submitted That Met QC Criteria: December 20, 2006
• First Posted (Estimate): December 21, 2006

Study Record Updates

• Last Update Posted (Estimate): August 23, 2013
• Last Update Submitted That Met QC Criteria: August 19, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pain, Intractable; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: 1622