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Botulinum Toxin in Burning Mouth Syndrome

NCT ID: NCT02964728

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Burning Mouth Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Botulinum toxin type A

Botulinum neurotoxin injections

Group Type EXPERIMENTAL

Botulinum Neurotoxin Type A

Intervention Type DRUG

topical injection

Placebo

Normal saline solution injections

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type OTHER

topical injection

Interventions

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Botulinum Neurotoxin Type A

topical injection

Intervention Type DRUG

Normal saline

topical injection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* burning mouth syndrome

Exclusion Criteria

* any other mouth disorder
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carlo Besta Neurological Institute

OTHER

Sponsor Role collaborator

University of Catania

OTHER

Sponsor Role collaborator

University of Padova

OTHER

Sponsor Role collaborator

Presidio Ospedaliero Garibaldi-Centro

OTHER

Sponsor Role lead

Responsible Party

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Domenico Antonio Restivo

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type RESULT
PMID: 15911160 (View on PubMed)

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.

Reference Type RESULT
PMID: 18546285 (View on PubMed)

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.

Reference Type RESULT
PMID: 12963779 (View on PubMed)

Other Identifiers

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BMS-1

Identifier Type: -

Identifier Source: org_study_id