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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01589432

Enrollment

Registered

2012-05-02

Start date

2012-04-30

Completion date

2012-11-30

Last updated

2013-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathic Pain

Keywords

Diabetic peripheral neuropathy

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.

Interventions

DRUGABT-639

two 50 mg oral capsules

DRUGPlacebo

2 placebo capsules

DRUGLidocaine

3mg/kg infusion over 30 minutes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Spontaneous activity in peripheral c-nociceptors	10 minute intervals over 180 minutes	Spontaneous activity in peripheral c-nociceptor measured through microneurography

Secondary

Measure	Time frame	Description
Pain intensity measurements	hourly for 4 hours	Pain intensity reported on a numerical rating scale

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026