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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Intractable Pain

Intervention / Treatment
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* Drug: Intraspinal Gabapentin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |