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

August 6, 2017 updated by: Myung Eun Chung, MD, PhD, Catholic University of Korea Saint Paul's Hospital
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • St. Paul's Hospital, The Catholic University of Korea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Normal saline
Other: Normal saline
Placebo
ACTIVE_COMPARATOR: Botulinum toxin type A 50U
Botulinum toxin 50U
Biological: Botulinum toxin type A
ACTIVE_COMPARATOR: Botulinum toxin type A 100U
Botulinum toxin 100U
Biological: Botulinum toxin type A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain intensity using numeric rating scale
Time Frame: 4 weeks after intervention
4 weeks after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain intensity using numeric rating scale
Time Frame: 1, 8, 12, 24 weeks after intervention
1, 8, 12, 24 weeks after intervention
Quality of life using WHOQOL
Time Frame: 4,8,12 weeks after intervention
4,8,12 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of Korea Saint Paul's Hospital

Collaborators

Medy-Tox

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ACTUAL)

November 30, 2016

Study Completion (ACTUAL)

December 31, 2016

Study Registration Dates

First Submitted

May 29, 2015

First Submitted That Met QC Criteria

June 1, 2015

First Posted (ESTIMATE)

June 2, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 8, 2017

Last Update Submitted That Met QC Criteria

August 6, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CatholicUKSPH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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