Botulinum Toxin Type A for Neuropathic Pain in Patients W... | NCT02460107

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

NCT02460107

Sponsor

Catholic University of Korea Saint Paul's Hospital

Status

Terminated

Last Update Posted

Aug 8, 2017Actual

Enrollment

9Actual

Phase

Early Phase 1

Conditions

Neuralgia

Interventions

Botulinum toxin type A
Normal saline

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Enrolling failure (lack of participants)

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Nov 30, 2016Actual

Completion Date

Dec 31, 2016Actual

First Submitted Date

May 29, 2015

First Submission Date that Met QC Criteria

Jun 1, 2015

First Posted Date

Jun 2, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2017

Last Update Posted Date

Aug 8, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Myung Eun Chung, MD, PhD, Catholic University of Korea Saint Paul's Hospital, Catholic University of Korea Saint Paul's HospitalPrincipal Investigator

Lead Sponsor

Catholic University of Korea Saint Paul's HospitalOTHER

Collaborators

Name	Class
Medy-Tox	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal saline	Placebo Comparator	Normal saline	Other: Normal saline
Botulinum toxin type A 50U	Active Comparator	Botulinum toxin 50U	Biological: Botulinum toxin type A
Botulinum toxin type A 100U	Active Comparator	Botulinum toxin 100U	Biological: Botulinum toxin type A

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Botulinum toxin type A	Biological		Botulinum toxin type A 100U Botulinum toxin type A 50U
Normal saline

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Paul's Hospital, The Catholic University of Korea		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D009437	Neuralgia

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019274	Botulinum Toxins, Type A
D000077330	Saline Solution

Ancestor Terms

ID	Term
D001905	Botulinum Toxins
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided