drugset / Trial / NCT05059418

Burning Mouth Syndrome - New Diagnostic Criteria and Treatment

NCT05059418

RandomizedSequentialTriple-blindTreatment

Summary

The first part of this study is to optimize diagnostic criteria for BMS, i.e. not a clinical trial, and will not be covered in this application. The second part will compare topical treatment with clonazepam, capsaicin and placebo in a n-of-1 study design regarding effects of pain, pain-related disability, somatosensory changes in the trigeminal nerve and patient experience in patients with primary BMS or other oral mucosal pain. The patients will be treated for two weeks with each drug, with a one-week wash-out period in between. After the last washed-out period, the patients will be able to chose the treatment that they prefer the most and continue with that treatment during 6 months.

Timeline

Start
2021-11-01
Primary completion
2023-12-31
Completion
2024-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capsaicin Small molecule Topical
Comparator Clonazepam Small molecule 0.5 mg Topical