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

Chronic Intractable Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00414466
• Other study ID #: 1622
• Status: Terminated
• Phase: Phase 2
• First received: December 20, 2006
• Last updated: August 19, 2013
• Start date: December 2006
• Est. completion date: August 2010

Study information

• Verified date: August 2013
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 254
• Est. completion date: August 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Intractable Pain
• Pain, Intractable

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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)	Yes
Secondary	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	No