A Safety and Effectiveness Study of Intraspinal Gabapentin (MDT2004) for the Treatment of Chronic Pain
TerminatedPhase 2NCT00414466
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- A Randomized Double Blind, Placebo-controlled, Dose Response Study of Intraspinal Gabapentin (MDT2004) in Subjects With Chronic, Intractable Pain.
- Conditions
- Chronic Intractable Pain
- Interventions
- Drug: Intraspinal Gabapentin
- Sponsor
- MedtronicNeuro
- Start date
- 2006-12
- Primary completion
- 2009-12
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 14
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00414466