Neuropathic Pain Study With Botulinum Toxin A in Spinal Cord Injury Patients

NCT01579500 | Completed Phase 4 DMC

• 3 other identifiers: PC12MIMV000520120007154suyon 2011-131
• Study Type: interventional
• Target: 40
• 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 spinal cord injury patients.

Conditions

Spinal Cord Injury; Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale

  4 weeks after intervention

Study Arms (2)

botulinum toxin A

ACTIVE COMPARATOR

Drug: Botulinum toxin type A

normal saline

PLACEBO COMPARATOR

Drug: normal saline

Interventions

Botulinum toxin type A DRUG

Subcutaneous injection of botulinum toxin type A

botulinum toxin A

normal saline DRUG

Subcutaneous injection of normal saline

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
• paraplegic or tetraplegic due to cervical and thoracic spinal cord injury
• more than 12 months since spinal cord injury and ASIA impairment scale unchanged for more than 6 months
• 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 40mm or more on the visual analogue scale

You may not qualify if:

• neuropathic pain caused by confounding factors other than spinal cord injury
• 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
• National Health Insurance Service Ilsan Hospital: collaborator
• Medy-Tox: collaborator

Study Sites (1)

Catholic University Saint Paul's Hospital; National Health Insurance Corporation Ilsan Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Neuralgia

Interventions

Botulinum Toxins, Type A; Saline Solution

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Peripheral Nervous System Diseases; Neuromuscular 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: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical assistant proffessor

Study Record Dates

• First Submitted: April 16, 2012
• First Posted: April 18, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 25, 2013

Record last verified: 2013-04

Locations

KR (1)