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

Primary Purpose

Neuralgia

Status
Terminated
Phase
Early Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Botulinum toxin type A
Normal saline
Sponsored by
Catholic University of Korea Saint Paul's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuralgia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Normal saline

Botulinum toxin type A 50U

Botulinum toxin type A 100U

Arm Description

Normal saline

Botulinum toxin 50U

Botulinum toxin 100U

Outcomes

Primary Outcome Measures

Pain intensity using numeric rating scale

Secondary Outcome Measures

Pain intensity using numeric rating scale
Quality of life using WHOQOL

Full Information

First Posted
May 29, 2015
Last Updated
August 6, 2017
Sponsor
Catholic University of Korea Saint Paul's Hospital
Collaborators
Medy-Tox
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1. Study Identification

Unique Protocol Identification Number
NCT02460107
Brief Title
Botulinum Toxin Type A for Neuropathic Pain in Patients With Diabetic Peripheral Polyneuropathy
Acronym
BTXADMPPNP
Official Title
Botulinum Toxin Type A for Neuropathic Pain in Patients With Diabetic Peripheral Polyneuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Enrolling failure (lack of participants)
Study Start Date
May 2015 (undefined)
Primary Completion Date
November 30, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of Korea Saint Paul's Hospital
Collaborators
Medy-Tox

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Normal saline
Arm Title
Botulinum toxin type A 50U
Arm Type
Active Comparator
Arm Description
Botulinum toxin 50U
Arm Title
Botulinum toxin type A 100U
Arm Type
Active Comparator
Arm Description
Botulinum toxin 100U
Intervention Type
Biological
Intervention Name(s)
Botulinum toxin type A
Intervention Type
Other
Intervention Name(s)
Normal saline
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Pain intensity using numeric rating scale
Time Frame
4 weeks after intervention
Secondary Outcome Measure Information:
Title
Pain intensity using numeric rating scale
Time Frame
1, 8, 12, 24 weeks after intervention
Title
Quality of life using WHOQOL
Time Frame
4,8,12 weeks after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
St. Paul's Hospital, The Catholic University of Korea
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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