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

NCT02460107 | Terminated Early Phase 1 DMC

• 1 other identifier: CatholicUKSPH
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuralgia

Outcome Measures

Primary Outcomes (1)

• Pain intensity using numeric rating scale

  4 weeks after intervention

Secondary Outcomes (2)

• Pain intensity using numeric rating scale

  1, 8, 12, 24 weeks after intervention

• Quality of life using WHOQOL

  4,8,12 weeks after intervention

Study Arms (3)

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

Botulinum toxin type A BIOLOGICAL

Botulinum toxin type A 100U; Botulinum toxin type A 50U

Normal saline OTHER

Placebo

Normal saline

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of Korea Saint Paul's Hospital: lead
• Medy-Tox: collaborator

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Botulinum Toxins, Type A; Saline Solution

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Catholic University of Korea Saint Paul's Hospital

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 2, 2015
• Study Start: May 1, 2015
• Primary Completion: November 30, 2016
• Study Completion: December 31, 2016
• Last Updated: August 8, 2017

Record last verified: 2017-08

Locations

KR (1)