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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01589432
Recruitment Status : Completed
First Posted : May 2, 2012
Last Update Posted : January 3, 2013
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

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 Type : Interventional  (Clinical Trial)
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 : April 2012
Primary Completion Date : November 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Lidocaine
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Spontaneous activity in peripheral c-nociceptors [ Time Frame: 10 minute intervals over 180 minutes ]
    Spontaneous activity in peripheral c-nociceptor measured through microneurography

Secondary Outcome Measures :
  1. Pain intensity measurements [ Time Frame: hourly for 4 hours ]
    Pain intensity reported on a numerical rating scale

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01589432

United Kingdom
Site Reference ID/Investigator# 68882
London, United Kingdom, SE1 3XF
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Study Director: Rita Jain, MD AbbVie

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AbbVie (prior sponsor, Abbott) Identifier: NCT01589432     History of Changes
Other Study ID Numbers: M13-383
2011-005127-40 ( EudraCT Number )
First Posted: May 2, 2012    Key Record Dates
Last Update Posted: January 3, 2013
Last Verified: January 2013

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Diabetic peripheral neuropathy

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action