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

NCT01589432 | Completed Phase 2

• 2 other identifiers: M13-3832011-005127-40
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Neuropathic Pain

Keywords

Diabetic peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• Spontaneous activity in peripheral c-nociceptors

  Spontaneous activity in peripheral c-nociceptor measured through microneurography

  10 minute intervals over 180 minutes

Secondary Outcomes (1)

• Pain intensity measurements

  hourly for 4 hours

Study Arms (3)

ABT-639

EXPERIMENTAL

Drug: ABT-639

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Lidocaine

ACTIVE COMPARATOR

Drug: Lidocaine

Interventions

ABT-639 DRUG

two 50 mg oral capsules

ABT-639

Placebo DRUG

2 placebo capsules

Placebo

Lidocaine DRUG

3mg/kg infusion over 30 minutes

Lidocaine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (1)

Site Reference ID/Investigator# 68882

London, SE1 3XF, United Kingdom

Location

Related Publications (1)

• Serra J, Duan WR, Locke C, Sola R, Liu W, Nothaft W. Effects of a T-type calcium channel blocker, ABT-639, on spontaneous activity in C-nociceptors in patients with painful diabetic neuropathy: a randomized controlled trial. Pain. 2015 Nov;156(11):2175-2183. doi: 10.1097/j.pain.0000000000000249.

  PMID: 26035253 DERIVED

MeSH Terms

Interventions

4-chloro-2-fluoro-N-(2-fluorophenyl)-5-(hexahydropyrrolo(1,2-a)pyrazin-2(1H)-ylcarbonyl)benzenesulfonamide; Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Rita Jain, MD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 2, 2012
• Study Start: April 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 3, 2013

Record last verified: 2013-01

Locations

GB (1)