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Trial record 79 of 720 for:    Botulinum Toxins, Type A

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

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ClinicalTrials.gov Identifier: NCT02460107
Recruitment Status : Terminated (Enrolling failure (lack of participants))
First Posted : June 2, 2015
Last Update Posted : August 8, 2017
Sponsor:
Collaborator:
Medy-Tox
Information provided by (Responsible Party):
Myung Eun Chung, MD, PhD, Catholic University of Korea Saint Paul's Hospital

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.

Condition or disease Intervention/treatment Phase
Neuralgia Biological: Botulinum toxin type A Other: Normal saline Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Botulinum Toxin Type A for Neuropathic Pain in Patients With Diabetic Peripheral Polyneuropathy
Study Start Date : May 2015
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Placebo Comparator: Normal saline
Normal saline
Other: Normal saline
Placebo

Active Comparator: Botulinum toxin type A 50U
Botulinum toxin 50U
Biological: Botulinum toxin type A
Active Comparator: Botulinum toxin type A 100U
Botulinum toxin 100U
Biological: Botulinum toxin type A



Primary Outcome Measures :
  1. Pain intensity using numeric rating scale [ Time Frame: 4 weeks after intervention ]

Secondary Outcome Measures :
  1. Pain intensity using numeric rating scale [ Time Frame: 1, 8, 12, 24 weeks after intervention ]
  2. Quality of life using WHOQOL [ Time Frame: 4,8,12 weeks after intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02460107


Locations
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Korea, Republic of
St. Paul's Hospital, The Catholic University of Korea
Seoul, Korea, Republic of
Sponsors and Collaborators
Catholic University of Korea Saint Paul's Hospital
Medy-Tox

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Responsible Party: Myung Eun Chung, MD, PhD, Catholic University of Korea Saint Paul's Hospital
ClinicalTrials.gov Identifier: NCT02460107     History of Changes
Other Study ID Numbers: CatholicUKSPH
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
Neuralgia
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents