Botulinum Toxin in Burning Mouth Syndrome

Burning Mouth Syndrome Clinical Trial

Official title:

Botulinum Toxin in Burning Mouth Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02964728
• Other study ID #: BMS-1
• Status: Completed
• Phase: Phase 2
• First received: November 12, 2016
• Last updated: December 5, 2016
• Start date: November 2015
• Est. completion date: May 2016

Study information

• Verified date: December 2016
• Source: Presidio Ospedaliero Garibaldi-Centro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• burning mouth syndrome

Exclusion Criteria:

• any other mouth disorder

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burning Mouth Syndrome
• Burns
• Syndrome

Intervention

Drug:
• Botulinum Neurotoxin Type A
topical injection

Other:
• Normal saline
topical injection

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Presidio Ospedaliero Garibaldi-Centro	Carlo Besta Neurological Institute, University of Catania, University of Padova

References & Publications (3)

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):332-7. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	0-100 mm Visual Analog Scale (VAS) improvement		1 month	Yes