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

Neuralgia Clinical Trial

— BTXADMPPNP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02460107
• Other study ID #: CatholicUKSPH
• Status: Terminated
• Phase: Early Phase 1
• First received: May 29, 2015
• Last updated: August 6, 2017
• Start date: May 2015
• Est. completion date: December 31, 2016

Study information

• Verified date: August 2017
• Source: Catholic University of Korea Saint Paul's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: December 31, 2016
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Polyneuropathies

Intervention

Biological:
• Botulinum toxin type A

Other:
• Normal saline
Placebo

Locations

Country	Name	City	State
Korea, Republic of	St. Paul's Hospital, The Catholic University of Korea	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Catholic University of Korea Saint Paul's Hospital	Medy-Tox

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity using numeric rating scale		4 weeks after intervention
Secondary	Pain intensity using numeric rating scale		1, 8, 12, 24 weeks after intervention
Secondary	Quality of life using WHOQOL		4,8,12 weeks after intervention