A Randomized, Double-blind, Placebo- and Active-controlled Study of the Electric Current Effects of ABT-639 on the Spontaneous Activity of Pain Sensory Receptors in Patients With Diabetic Peripheral Neuropathy

Study Overview
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Brief Summary
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People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.

Official Title
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A Randomized, Double-blind, Placebo and Active-controlled Study of the Electrophysiological Effects of ABT-639 on Spontaneous Activity in C-Nociceptors in Patients With Painful Diabetic Peripheral Neuropathy

Conditions
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Diabetic Neuropathic Pain

Intervention / Treatment
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* Drug: ABT-639
* Drug: Placebo
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subject is between the ages of 18 to 75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months. Subject must have an average score of greater than or equal to 4 on the 24 hour average pain score (0-10 numerical rating scale) collected over approximately 7 days prior to the Baseline Visit. Exclusion Criteria Subject has clinically symptomatic neuropathic pain conditions that can not be distinguished from diabetic neuropathic pain or interfere with the pain assessments of diabetic neuropathic pain. A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with diabetic neuropathic pain assessments or other functions. Subject has clinically significant abnormalities in clinical laboratory tests.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABT-639<br> | Drug: ABT-639<br>* two 50 mg oral capsules<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 2 placebo capsules<br>|
| Active Comparator: Lidocaine<br> | Drug: Lidocaine<br>* 3mg/kg infusion over 30 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous activity in peripheral c-nociceptors | Spontaneous activity in peripheral c-nociceptor measured through microneurography | 10 minute intervals over 180 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity measurements | Pain intensity reported on a numerical rating scale | hourly for 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic peripheral neuropathy