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

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

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.

Study Overview

• Status: Terminated
• Conditions: Diabetic Neuropathic Pain
• Intervention / Treatment: Drug: Placebo; Drug: ABT-652 6 mg; Drug: ABT-652 12 mg; Drug: ABT-652 12 mg - 18 mg; Drug: Duloxetine

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Site Reference ID/Investigator# 62887
    • Walnut Creek, California, United States, 94598
      • Site Reference ID/Investigator# 62824
  • Connecticut
    • Milford, Connecticut, United States, 06460
      • Site Reference ID/Investigator# 63710
  • Florida
    • DeLand, Florida, United States, 32720
      • Site Reference ID/Investigator# 62884
    • Orlando, Florida, United States, 32806
      • Site Reference ID/Investigator# 62826
  • Massachusetts
    • Brockton, Massachusetts, United States, 02301
      • Site Reference ID/Investigator# 63703
  • Mississippi
    • Olive Branch, Mississippi, United States, 38654
      • Site Reference ID/Investigator# 73913
  • Texas
    • Dallas, Texas, United States, 75231
      • Site Reference ID/Investigator# 62886

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AbbVie (prior sponsor, Abbott)

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: April 16, 2012
• First Submitted That Met QC Criteria: April 16, 2012
• First Posted (Estimate): April 17, 2012

Study Record Updates

• Last Update Posted (Estimate): September 26, 2013
• Last Update Submitted That Met QC Criteria: September 24, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Diabetic neuropathic pain; Active controlled phase 2 study
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Duloxetine Hydrochloride
• Other Study ID Numbers: M11-210; 2011-003939-56 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No