A Study Comparing the Efficacy and Safety of ABT-652 to Placebo in Subjects With Diabetic Neuropathic Pain

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of ABT-652 compared to Placebo in subjects with diabetic neuropathic pain. 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.

Detailed Description
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A double blind, randomized, active- and placebo-controlled 13-week study. Duloxetine is added to evaluate assay sensitivity.

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-652 to Placebo in Subjects With Diabetic Neuropathic Pain

Conditions
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Diabetic Neuropathic Pain

Intervention / Treatment
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* Drug: ABT-652 6 mg
* Drug: ABT-652 12 mg
* Drug: ABT-652 12 mg - 18 mg
* Drug: Placebo
* Drug: Duloxetine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is between the ages of 18-75 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 a mean average score of greater than 4 on the 24 hour average pain score (0-10 numerical rating scale) prior to the Baseline Visit. Subject has been on a medication for diabetic neuropathic pain for the past 3 months. Exclusion Criteria: Subject has clinically symptomatic neuropathic pain conditions that cannot 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. Subject has taken an opioid chronically, excluding tramadol within the last 3 months prior to Screening.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABT-652 6 mg<br>ABT-652 capsules - twice daily | Drug: ABT-652 6 mg<br>* 6 mg capsules<br>|
| Experimental: ABT-652 12 mg<br>ABT-652 capsules twice daily | Drug: ABT-652 12 mg<br>* 12 mg capsules<br>|
| Experimental: ABT-652 12 mg - 18 mg<br>ABT-652 capsules twice daily | Drug: ABT-652 12 mg - 18 mg<br>* 12 mg - 18 mg capsules<br>|
| Placebo Comparator: Placebo<br>Placebo capsules twice daily | Drug: Placebo<br>* Placebo capsules<br>|
| Active Comparator: Duloxetine<br>Duloxetine capsules once daily | Drug: Duloxetine<br>* Duloxetine capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour Average Pain Score | Weekly mean of 24-hour average pain score measured by a 11-point Numeric Rating Scale completed on subject's daily diary. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropathic Pain Symptom Inventory | Measures severity of common neuropathic pain qualities (burning, pressure, squeezing) | 12 weeks | 
| Patient Global Impression of Change | Captures the subject's evaluation of his/her overall general impression of feeling since beginning study medication | 12 weeks | 
| Brief Pain Inventory | Capture the subject's severity of pain and interference | 12 weeks | 
| Neuropathic Pain Impact on Quality of Life Questionnaire | Captures the subject's assessment of neuropathic pain and the effect it has on the quality of daily life | 12 weeks | 
| EuroQuality of Life - 5 Dimension -5 Level | Capture's the subject's mobility, self-care, usual activity, pain/discomfort and anxiety/depression | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic neuropathic pain, Active controlled phase 2 study