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

Catholic University of Korea Saint Paul's Hospital

Status and phase: Terminated; Early Phase 1

Conditions: Neuralgia

Treatments: Other: Normal saline; Biological: Botulinum toxin type A

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02460107

CatholicUKSPH

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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9 participants in 3 patient groups, including a placebo group

Normal saline

Placebo Comparator group

Description:

Normal saline

Treatment:

Other: Normal saline

Botulinum toxin type A 50U

Active Comparator group

Description:

Botulinum toxin 50U

Treatment:

Biological: Botulinum toxin type A

Botulinum toxin type A 100U

Active Comparator group

Description:

Botulinum toxin 100U

Treatment:

Biological: Botulinum toxin type A