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Intraoral Administration of Botox in Patients With Dentoalveolar Neuropathic Pain

Sponsor
Isabel Moreno Hay (Other)
Overall Status
Recruiting
CT.gov ID
NCT03848143
Collaborator
Allergan Sales, LLC (Industry)
10
Enrollment
1
Location
1
Arm
39.7
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: onabotulinum toxin A
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single subject experimental designSingle 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
Actual Study Start Date :
Sep 11, 2019
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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 Names:
  • BOTOX

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain Intensity [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Orofacial Pain Center Lexington Kentucky United States 40536

    Sponsors and Collaborators

    • Isabel Moreno Hay
    • Allergan Sales, LLC

    Investigators

    • Study Director: Jeffrey P Okeson, DMD, Associate Professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Isabel Moreno Hay, Assistant Professor, University of Kentucky
    ClinicalTrials.gov Identifier:
    NCT03848143
    Other Study ID Numbers:
    • 45231
    • IIT-10247
    First Posted:
    Feb 20, 2019
    Last Update Posted:
    Dec 10, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Neuralgia

    Study Results

    No Results Posted as of Dec 10, 2021