A Multicenter Study Comparing the Analgesic Effects and Safety of ABT-639 Compared to Placebo in Subjects With Diabetic Neuropathic Pain

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 Multicenter, Randomized, Double-Blind, Placebo and Active Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-639 to Placebo in Subjects With Diabetic Neuropathic Pain

Conditions
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Diabetic Neuropathic Pain

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


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 (DNP) or interfere with the pain assessments of DNP. A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with DNP 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABT-639<br>ABT-639 twice daily for 6 weeks | Drug: ABT-639<br>* ABT-639 Twice Daily for six weeks.<br>|
| Active Comparator: pregabalin<br>pregabalin starting dose twice daily for week one then titrated up to maintenance dose twice daily for duration of the study | Drug: pregabalin<br>* pregabalin starting dose twice daily for 1 week then titrated to maintenance dose twice daily for the remainder of the study.<br>* Other names: Lyrica;|
| Placebo Comparator: Placebo<br>Placebo twice daily for 6 weeks | Drug: Placebo<br>* Placebo twice daily for 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary | Daily questions asked on a hand held diary | Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Global Impression of Change | Paper questionnaire | Week 2, Week 4 and Week 6 (End of Study) | 
| Brief Pain Inventory (BPI) (short form) including Severity and Interference | Paper questionnaire | At each visit up to Week 6 (end of Study) | 
| Neuropathic Pain Symptom Inventory (NPSI) | Paper questionnaire | Baseline, Week 2, Week 4 and Week 6 (end of Study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Asymmetric Polyneuropathy, Symmetric Diabetic Proximal Motor Neuropathy, Diabetic Mononeuropathy Simplex,, Diabetic Autonomic Neuropathy,, Diabetic Amyotrophy, Mononeuropathy, Diabetic Neuropathy, Asymmetric Diabetic Proximal Motor Neuropathy, Diabetic Polyneuropathy, Painful, Diabetic Mononeuropathy, Neuralgia