Botulinum Toxin Type A for Neuropathic Pain in Patients With Diabetic Peripheral Polyneuropathy

Catholic University of Korea Saint Paul's Hospital1 site in 1 country9 target enrollmentMay 2015

ConditionsNeuralgia

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: Neuralgia
Sponsor: Catholic University of Korea Saint Paul's Hospital
Enrollment: 9
Locations: 1
Primary Endpoint: Pain intensity using numeric rating scale
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether botulinum toxin A is effective in the treatment of neuropathic pain in patients with diabetic peripheral polyneuropathy.

Registry

clinicaltrials.gov

Start Date

May 2015

End Date

December 31, 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Catholic University of Korea Saint Paul's Hospital

Responsible Party

Principal Investigator

Myung Eun Chung, MD, PhD

Catholic University of Korea Saint Paul's Hospital

Eligibility Criteria

Inclusion Criteria

•• more than twenty years of age
•patients should have 4 or more items positive among the 10 items of the DN4 questionnaire.
•persistence of neuropathic pain for more than three months or remission and recurrence of neuropathic pain for more than six months
•a pain score of 4 or more on the numeric rating scale

Exclusion Criteria

•• neuropathic pain caused by confounding factors other than diabetic neuropathic pain
•contraindicated for botulinum toxin type A
•a change in pain medication one month prior to study enrollment
•a condition involving neuromuscular junction (Ex. Eaton Lambert disease, myasthenia gravis)
•person who received botulinum toxin type A within three months prior to study enrollment