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Botulinum Toxin in Burning Mouth Syndrome

Primary Purpose

Burning Mouth Syndrome

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Botulinum Neurotoxin Type A
Normal saline
Sponsored by
Presidio Ospedaliero Garibaldi-Centro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burning Mouth Syndrome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • burning mouth syndrome

Exclusion Criteria:

  • any other mouth disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Botulinum toxin type A

    Placebo

    Arm Description

    Botulinum neurotoxin injections

    Normal saline solution injections

    Outcomes

    Primary Outcome Measures

    0-100 mm Visual Analog Scale (VAS) improvement

    Secondary Outcome Measures

    Full Information

    First Posted
    November 12, 2016
    Last Updated
    December 5, 2016
    Sponsor
    Presidio Ospedaliero Garibaldi-Centro
    Collaborators
    Carlo Besta Neurological Institute, University of Catania, University of Padova
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02964728
    Brief Title
    Botulinum Toxin in Burning Mouth Syndrome
    Official Title
    Botulinum Toxin in Burning Mouth Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Presidio Ospedaliero Garibaldi-Centro
    Collaborators
    Carlo Besta Neurological Institute, University of Catania, University of Padova

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The effect of botulinum neurotoxin type A intradermal injection in will be evaluated in 4 patients with clinical diagnosis of burning mouth syndrome involving the anterior two-thirds of the tongue and the lower lip for at least 6 months, refractory to common pharmacological treatments. Pain severity will be measured by the visual analog scale (VAS) indicating average week pain before injection. Each patient will be injected with a total dose of 16 units (dilution: 2 ml saline) of incobotulinumA: 4 units into each side of the lower lip and 4 units into each antero-lateral side of the tongue. In order to determine if a placebo effect may be involved, we will inject 2 additional patients with saline solution using the same volumes and the same injection sites. Patients will be evaluated at 48 hours and then at 4, 8, 12, 16 and 20 weeks after the treatment. Patients treated with placebo will be treated after 4 weeks with incobotulinumA with the same dose reported above.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Burning Mouth Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    6 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Botulinum toxin type A
    Arm Type
    Experimental
    Arm Description
    Botulinum neurotoxin injections
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Normal saline solution injections
    Intervention Type
    Drug
    Intervention Name(s)
    Botulinum Neurotoxin Type A
    Intervention Description
    topical injection
    Intervention Type
    Other
    Intervention Name(s)
    Normal saline
    Intervention Description
    topical injection
    Primary Outcome Measure Information:
    Title
    0-100 mm Visual Analog Scale (VAS) improvement
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: burning mouth syndrome Exclusion Criteria: any other mouth disorder

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    15911160
    Citation
    Lauria G, Majorana A, Borgna M, Lombardi R, Penza P, Padovani A, Sapelli P. Trigeminal small-fiber sensory neuropathy causes burning mouth syndrome. Pain. 2005 Jun;115(3):332-337. doi: 10.1016/j.pain.2005.03.028.
    Results Reference
    result
    PubMed Identifier
    18546285
    Citation
    Ranoux D, Attal N, Morain F, Bouhassira D. Botulinum toxin type A induces direct analgesic effects in chronic neuropathic pain. Ann Neurol. 2008 Sep;64(3):274-83. doi: 10.1002/ana.21427. Erratum In: Ann Neurol. 2009 Mar;65(3):359.
    Results Reference
    result
    PubMed Identifier
    12963779
    Citation
    Restivo DA, Tinazzi M, Patti F, Palmeri A, Maimone D. Botulinum toxin treatment of painful tonic spasms in multiple sclerosis. Neurology. 2003 Sep 9;61(5):719-20. doi: 10.1212/01.wnl.0000080081.74117.e4. No abstract available.
    Results Reference
    result

    Learn more about this trial

    Botulinum Toxin in Burning Mouth Syndrome

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