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

AbbVie

Status and phase: Terminated; Phase 2

Conditions: Diabetic Neuropathic Pain

Treatments: Drug: ABT-652 12 mg - 18 mg; Drug: ABT-652 12 mg; Drug: Duloxetine; Drug: Placebo; Drug: ABT-652 6 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01579279

M11-210

2011-003939-56 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 1 patient

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1 participants in 5 patient groups, including a placebo group

ABT-652 6 mg

Experimental group

Description:

ABT-652 capsules - twice daily

Treatment:

Drug: ABT-652 6 mg

ABT-652 12 mg

Experimental group

Description:

ABT-652 capsules twice daily

Treatment:

Drug: ABT-652 12 mg

ABT-652 12 mg - 18 mg

Experimental group

Description:

ABT-652 capsules twice daily

Treatment:

Drug: ABT-652 12 mg - 18 mg

Placebo

Placebo Comparator group

Description:

Placebo capsules twice daily

Treatment:

Drug: Placebo

Duloxetine

Active Comparator group

Description:

Duloxetine capsules once daily

Treatment:

Drug: Duloxetine