A Safety and Effectiveness Study of Intraspinal MDT2004 for the Treatment of Chronic Pain - Full Text View

Purpose

The purpose of this study is to determine the safety and minimum effective dose of intraspinal MDT2004 when delivered through an implanted drug infusion system.

Condition	Intervention	Phase
Chronic Intractable Pain	Drug: Intraspinal MDT2004	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized Double Blind, Placebo-controlled, Dose Response Study of Intraspinal MDT2004 in Subjects With Chronic, Intractable Pain.

Resource links provided by NLM:

MedlinePlus related topics: Chronic Pain

U.S. FDA Resources

Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:

Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment. [ Time Frame: Baseline and Post-randomization Day 22 ] [ Designated as safety issue: No ]
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.
Treatment-emergent Adverse Events [ Time Frame: Randomization to Post-randomization Day 29 (includes dose reduction) ] [ Designated as safety issue: Yes ]
Evaluation of adverse event profiles between placebo and active treatment groups.

Secondary Outcome Measures:

Responder Analysis Between Active Treatment and Placebo Groups. [ Time Frame: Baseline to Post-randomization Day 22 ] [ Designated as safety issue: No ]
Responders were subjects that reported at least a 30% decrease in average daily pain scores between baseline and Day 22.

Enrollment:	254
Study Start Date:	December 2006
Study Completion Date:	August 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system	Drug: Intraspinal MDT2004 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: MDT2004 Low Intraspinal MDT2004 Low delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose	Drug: Intraspinal MDT2004 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: MDT2004 Medium Intraspinal MDT2004 Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose	Drug: Intraspinal MDT2004 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: MDT2004 High Intraspinal MDT2004 High delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose	Drug: Intraspinal MDT2004 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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414466

Locations

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

Sponsors and Collaborators

MedtronicNeuro

More Information

No publications provided

Responsible Party:	Medtronic Neuromodulation, Medtronic, Inc.
ClinicalTrials.gov Identifier:	NCT00414466 History of Changes
Other Study ID Numbers:	1622
Study First Received:	December 20, 2006
Results First Received:	December 22, 2010
Last Updated:	May 6, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Pain, Intractable
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013