Use of Topical Lidocaine to Reduce Pain in Patients With Diabetic Neuropathy

NCT01086150 | Completed Phase 2 Results

• 1 other identifier: ENDO
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if an investigational drug known as the lidocaine 5% patch is safe and effective in reducing the symptoms of diabetic neuropathy, to examine how topical lidocaine affects the nerve endings, and to determine whether treatment with the lidocaine patch can prevent the potential progression to chronic diabetic neuropathy pain in subjects who did not report pain at the start of the study.

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Pain Scores From Composite Visual Analog Scale

  Scores range from 0 to 10 with higher scores indicating higher levels of pain.

  baseline, 4 weeks

Secondary Outcomes (1)

• Keratinocyte Immunoreactivity of Nav1.6, Nav1.7, CGRP

  Baseline, 4 weeks

Study Arms (3)

Healthy control patients

OTHER

Subjects 18 to 70 years of age, non-diabetic with no nervous system disease. Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study.

Procedure: Skin biopsy; Drug: Lidocaine 5% patches

Type I or Type II diabetes with painful diabetic neuropathy

OTHER

18 to 70 years old with significantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study.

Procedure: Skin biopsy; Drug: Lidocaine 5% patches

patients with non-painful diabetic peripheral neuropathy

OTHER

18-70 years of age with Type I or Type II diabetes with non-painful or insignificantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at baseline, 4 weeks, and end of study.

Procedure: Skin biopsy; Drug: Lidocaine 5% patches

Interventions

Skin biopsy PROCEDURE

Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes.

Healthy control patients; Type I or Type II diabetes with painful diabetic neuropathy; patients with non-painful diabetic peripheral neuropathy

Lidocaine 5% patches DRUG

Subject will apply patches to affected area QD for 12 hours then remove.

Healthy control patients; Type I or Type II diabetes with painful diabetic neuropathy; patients with non-painful diabetic peripheral neuropathy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Group 1: 18-70 years of age, non-diabetic with no nervous system disease (healthy control group)
• Group 2: 18-70 years of age with Type I or Type II diabetes with significantly painful diabetic neuropathy (VAS \> 40mm at Baseline)
• Group 3: 18-70 years of age with Type I or Type II diabetes with non- painful or insignificantly painful diabetic neuropathy (VAS \< 40mm at Baseline)

You may not qualify if:

• Allergy to lidocaine
• Unwillingness to sign informed consent or any other reasons for which the investigator feels the subject cannot complete the study
• Women who are pregnant, breastfeeding or trying to become pregnant
• History of slow-healing diabetic foot ulcers
• Current skin or soft tissue lesions on the foot that will interfere with application of the lidocaine patch and or skin biopsies
• Subjects taking Class I antiarrhythmics
• HgA1c \> 11%
• Active cancer within the previous two years except treated basal cell carcinoma of the skin
• Co-morbidities that can produce neuropathy
• Subjects taking sodium channel blockers within one week of study treatment and throughout the study
• Subjects taking any other experimental drugs within 30 days prior to Screening Visit (Visit 1)
• Application of lidocaine patch to either foot within two weeks of Screening Visit (Visit 1)

Sponsors & Collaborators

• Albany Medical College: lead
• Endo Pharmaceuticals: collaborator

Study Sites (1)

Albany Medical College

Albany, New York, 12208, United States

Location

MeSH Terms

Interventions

Lidocaine; Transdermal Patch

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Equipment and Supplies

Results Point of Contact

• Title: Charles E. Argoff, MD
• Organization: Albany Medical College

argoffc@mail.amc.edu

518 262-0034

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 12, 2010
• Study Start: October 1, 2009
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: June 11, 2020
• Results First Posted: June 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)