Back to resultsA 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
Primary Purpose
Diabetic Neuropathic Pain
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
ABT-639
Placebo
Lidocaine
Sponsored by
About this trial
This is an interventional basic science trial for Diabetic Neuropathic Pain focused on measuring Diabetic peripheral neuropathy
Eligibility Criteria
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.
Sites / Locations
- Site Reference ID/Investigator# 68882
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
ABT-639
Placebo
Lidocaine
Arm Description
Outcomes
Primary Outcome Measures
Spontaneous activity in peripheral c-nociceptors
Spontaneous activity in peripheral c-nociceptor measured through microneurography
Secondary Outcome Measures
Pain intensity measurements
Pain intensity reported on a numerical rating scale
Full Information
NCT ID
NCT01589432
First Posted
April 30, 2012
Last Updated
January 2, 2013
Sponsor
AbbVie (prior sponsor, Abbott)
1. Study Identification
Unique Protocol Identification Number
NCT01589432
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathic Pain
Keywords
Diabetic peripheral neuropathy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABT-639
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Lidocaine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ABT-639
Intervention Description
two 50 mg oral capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 placebo capsules
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
3mg/kg infusion over 30 minutes
Primary Outcome Measure Information:
Title
Spontaneous activity in peripheral c-nociceptors
Description
Spontaneous activity in peripheral c-nociceptor measured through microneurography
Time Frame
10 minute intervals over 180 minutes
Secondary Outcome Measure Information:
Title
Pain intensity measurements
Description
Pain intensity reported on a numerical rating scale
Time Frame
hourly for 4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita Jain, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 68882
City
London
ZIP/Postal Code
SE1 3XF
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
26035253
Citation
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.
Results Reference
derived
Learn more about this trial
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
We'll reach out to this number within 24 hrs