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.

Conditions: Diabetec Neuropathic Pain
MedDRA version: 14.1Level: LLTClassification code 10012683Term: Diabetic peripheral neuropathySystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2011-005127-40-GB

Lead Sponsor: Abbott GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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 = 4 on the 24 hour average pain score (0-10 numerical rating scale) collected over approximately 7 days prior to the Baseline Visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

Subject has clinically symptomatic neuropathic pain conditions that can not be distinguished from 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effect of single dose of ABT-639 on spontaneous activity in peripheral C nociceptors measured through microneurography in subjects with painful diabetic peripheral neuropathy (DPN) compared to placebo and lidocaine.;Secondary Objective: To assess the safety, tolerability, and pharmacokinetics of a single dose of ABT 639.;Primary end point(s): Number of Significant Latency Increases (SLI) per minute.<br><br>Maximum Increase: the largest individual SLI expressed as a percentage of baseline latency.<br><br>Total Increase: sum of individual SLI increases.<br><br>Total spikes<br><br>Spikes/min;Timepoint(s) of evaluation of this end point: Recordings for 10 minute intervals after the oral dose for each C fiber for which microneurography recording is done. Note that recording may be done for a subject on more than one C fiber.

Secondary Outcome Measures