Burning Mouth SyndromePhase 2NCT02964728
Botulinum Toxin in Burning Mouth Syndrome
A Phase 2 study testing Botulinum Neurotoxin Type A and Normal saline in people with Burning Mouth Syndrome, run by Presidio Ospedaliero Garibaldi-Centro.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burning Mouth Syndrome
- What is being tested?
- Botulinum Neurotoxin Type A and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to May 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- burning mouth syndrome
Who cannot join
- any other mouth disorder
About this study
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.
- Conditions
- Burning Mouth Syndrome
- Being tested
- Botulinum Neurotoxin Type A, Normal saline
- Medical subject headings
- Burning Mouth Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Neurotoxin Type ADrug
topical injection
Normal salineOther
topical injection
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin type A | Experimental | Botulinum neurotoxin injections Receives: Drug: Botulinum Neurotoxin Type A |
| Placebo | Placebo comparator | Normal saline solution injections Receives: Other: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
0-100 mm Visual Analog Scale (VAS) improvement
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startNov 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Burning Mouth SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Presidio Ospedaliero Garibaldi-Centro
- Sponsor type
- University, hospital or other
- Collaborators
- Carlo Besta Neurological Institute, University of Catania, University of Padova
- Responsible party
- Principal investigator, Domenico Antonio Restivo, Presidio Ospedaliero Garibaldi-Centro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964728
- Sponsor's protocol ID
- BMS-1
- Status last verified
- Dec 2016
- First submitted
- 12 Nov 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 15911160Ranoux 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.
PubMed 18546285Restivo 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.
PubMed 12963779
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin in Burning Mouth Syndrome
- ClinicalTrials.gov ID
- NCT02964728
- Acronym / sponsor ID
- BMS-1
- Conditions
- Burning Mouth Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Presidio Ospedaliero Garibaldi-CentroUniversity, hospital or other
- Collaborators
- Carlo Besta Neurological Institute, University of Catania, University of Padova
- Study start
- Nov 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 16 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin type A | Experimental | Drug: Botulinum Neurotoxin Type ABotulinum neurotoxin injections |
| Placebo | Placebo comparator | Other: Normal salineNormal saline solution injections |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- burning mouth syndrome
Key exclusion criteria (1 listed)
- any other mouth disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Neurotoxin Type Atopical injection | Drug | Botulinum toxin type A |
| Normal salinetopical injection | Other | Placebo |
Primary outcome
0-100 mm Visual Analog Scale (VAS) improvement
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
- Results publication: PubMed 15911160Lauria 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 publication: PubMed 18546285Ranoux 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.
- Results publication: PubMed 12963779Restivo 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.
- Individual participant dataSharing planned: No
Related trials for Burning Mouth Syndrome
Not yet recruiting
Improving Prescribing Quality for Oral Mucosal Disorders Using a Pharmacist-Led Model
Oral Lichen Planus, Recurrent Aphthous Stomatitis
Recruiting
MucoLock™ for Treatment of Stomatitis
Stomatitis, Pain
RecruitingObservational study
Reducing Patient Memory Recall in the Burning Mouth Patient Population
Burning Mouth Syndrome
Active, not recruiting
Photobiomodulation Therapy vs. Alpha-Lipoic Acid in Burning Mouth Syndrome Treatment
Burning Mouth Syndrome, Low Level Laser Therapy
Not yet recruiting
Burning Mouth Syndrome: Effects of Occlusal Splint Therapy
Burning Mouth Syndrome, Orofacial Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum Neurotoxin Type A and Normal saline in people with Burning Mouth Syndrome, run by Presidio Ospedaliero Garibaldi-Centro.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
0-100 mm Visual Analog Scale (VAS) improvement (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02964728, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2016.