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Intraoral Administration of Botox in Patients With Dentoalveolar Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT03848143
Recruitment Status : Not yet recruiting
First Posted : February 20, 2019
Last Update Posted : February 25, 2019
Sponsor:
Collaborator:
Allergan Sales, LLC
Information provided by (Responsible Party):
Isabel Moreno Hay, University of Kentucky

Brief Summary:

Onabotulinum toxin type A (BoNT-A) is a potent neurotoxin that has been reported to have an effect on afferent (sensory) neurons independent of its action on muscle tone and secretory glands at the periphery.In human studies, the use of BoNT-A has proven to reduce the severity and intensity of attacks in chronic tension type headaches and chronic neck pain. The PREEMPT study concluded that BoNT-A could be used as a preventive therapy in chronic migraine patients and FDA approval was obtained. According to the International Association for the Study of Pain (IASP), BoNT-A is recommended for the management of peripheral neuropathic pain with subcutaneous administration of 50-200 units (50-200U) to onabotulinum toxin A to the painful neuropathic area every 3 months as a third line of treatment. To our knowledge, there are no clinical trials published investigating the effect of intraoral administration of BoNT-A in continuous dentoalveolar neuropathic pain. The aim of this pilot study is to investigate the potential therapeutic effect of intraoral administration of BoNT-A in patients suffering from continuous neuropathic pain.

HYPOTHESIS:

There will be statistically significant differences in reported pain intensity after the intraoral administration of BOTOX® in patients suffering from chronic continuous dentoalveolar neuropathic pain.

A single subject experiment will be conducted with 10 patients where 50 U of BonT-A will be injected into the painful dentoalveolar area. Eligible subjects will complete a pain diary indicating their pain intensity by means of a visual analog scale during one month to establish a baseline. After the first injection, subjects will continue to monitor the VAS daily for 3 months and the infiltration will be repeated a second time following the same protocol. Patient's response will be monitored with the daily pain diary.


Condition or disease Intervention/treatment Phase
Neuropathic Pain Drug: onabotulinum toxin A Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single subject experimental design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intraoral Administration of Onabotulinum Toxin A for Continuous Neuropathic Pain: a Single Subject Experimental Design
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: BOTOX

Onabotulinum toxin A is distributed in 50 unit (50U) vacuum-dried powder bottles by Allergan (BOTOX (R)) for reconstitution only with sterile, preservative-free 0.9% Sodium Chloride Injection prior to injection.

1 mL of diluent will be drawn up to obtain a resulting dose of 10 U per 0.2 mL and injected into the vial. The BOTOX(R) will then be gently mixed with the saline by rotating the vial. The date and time of reconstitution will be recorded on the package on the label. BOTOX should be administered within 24 hours after reconstitution and stored in a refrigerator (2-8 °C).

Each patient will receive 50 U of onabotulinum toxin A.

Drug: onabotulinum toxin A
Each subject will receive 50 units (50 U) of BoNT-A constituted in 1 mL of saline solution injected intraorally to the painful area divided in at least 3 sites, 0.5 to 1.0 cm apart depending on the size of the painful area and following a checkerboard pattern.
Other Name: BOTOX




Primary Outcome Measures :
  1. Pain Intensity [ Time Frame: Over 7 months ]
    Patient will record the pain intensity by means of a visual analogue scale (VAS, from 0-10 being 0 no pain and 10 the worst possible pain)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of continuous dentoalveolar pain with clinically evident positive (hyperalgesia, allodynia) and/or negative (hypoaesthesia, hypoalgesia) signs of trigeminal nerve dysfunction and where other possible pain sources have been ruled out.
  • Intractable pain to conventional oral and/or topical pharmacotherapy for neuropathic pain according to the recommendations published by NeuPSIG (Neuropathic Pain Special Interest Group) including anticonvulsants, SNRIs (serotonin and norepinephrine reuptake inhibitors) and/or tricyclic antidepressants.
  • Subject consent to participate in the study.

Exclusion Criteria:

  • hypersensitive to any onabotulinum toxin preparation or any component in the formulation.
  • systemic nerve or muscle disorders
  • bleeding disorders
  • dysphagia
  • breathing problems
  • pregnancy or breastfeeding
  • previous treatment with botulinum toxin in the last 4 months.

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): NCT03848143


Contacts
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Contact: Isabel Moreno Hay, DDS PhD 8593233440 imo226@uky.edu

Locations
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United States, Kentucky
Orofacial Pain Center
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Isabel Moreno Hay
Allergan Sales, LLC
Investigators
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Study Director: Jeffrey P Okeson, DMD Associate Professor

Publications:

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Responsible Party: Isabel Moreno Hay, Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT03848143     History of Changes
Other Study ID Numbers: 45231
IIT-10247 ( Other Identifier: Allergan Sales LLC )
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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