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

NCT ID: NCT02460107

Last Updated: 2017-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Normal saline

Normal saline

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type OTHER

Placebo

Botulinum toxin type A 50U

Botulinum toxin 50U

Group Type ACTIVE_COMPARATOR

Botulinum toxin type A

Intervention Type BIOLOGICAL

Botulinum toxin type A 100U

Botulinum toxin 100U

Group Type ACTIVE_COMPARATOR

Botulinum toxin type A

Intervention Type BIOLOGICAL

Interventions

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Botulinum toxin type A

Intervention Type BIOLOGICAL

Normal saline

Placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medy-Tox

INDUSTRY

Sponsor Role collaborator

Catholic University of Korea Saint Paul's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Myung Eun Chung, MD, PhD

Catholic University of Korea Saint Paul's Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CatholicUKSPH

Identifier Type: -

Identifier Source: org_study_id

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