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

• Sponsor: AbbVie (prior sponsor, Abbott) (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01589432
• Collaborator: (none)
• Enrollment: 39
• Location: 1
• Arms: 3
• Duration (Months): 7
• Patients Per Site Per Month: 5.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Neuropathic Pain	Drug: ABT-639; Drug: Placebo; Drug: Lidocaine	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: 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
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ABT-639	Drug: ABT-639; two 50 mg oral capsules
Placebo Comparator: Placebo	Drug: Placebo; 2 placebo capsules
Active Comparator: Lidocaine	Drug: Lidocaine; 3mg/kg infusion over 30 minutes

Outcome Measures

Primary Outcome Measures

1. Spontaneous activity in peripheral c-nociceptors [10 minute intervals over 180 minutes]

   Spontaneous activity in peripheral c-nociceptor measured through microneurography

Secondary Outcome Measures

1. Pain intensity measurements [hourly for 4 hours]

   Pain intensity reported on a numerical rating scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 68882	London		United Kingdom	SE1 3XF

Sponsors and Collaborators

• AbbVie (prior sponsor, Abbott)

Investigators

• Study Director: Rita Jain, MD, AbbVie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AbbVie (prior sponsor, Abbott)
• ClinicalTrials.gov Identifier: NCT01589432
• Other Study ID Numbers: M13-383; 2011-005127-40
• First Posted: May 2, 2012
• Last Update Posted: Jan 3, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by AbbVie (prior sponsor, Abbott): Diabetic peripheral neuropathy
• Additional relevant MeSH terms: Neuralgia; Peripheral Nervous System Diseases; Lidocaine

Study Results

No Results Posted as of Jan 3, 2013