Overview
Sponsor-declared trial summary
Burning mouth syndrome
The project will be divided into two studies: The objective of the sub-studies will be: 1. Investigate the effect of topical treatment with clonazepam on pain intensity, Consequences of pain, sensory changes and jaw function in patients with BMS for two weeks. In particular, patients' own preference, experience of th…
Key facts
- Sponsor
- Malmoe Universitet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Stomatognathic Diseases [C07]
- Trial duration
- 16 Jun 2025 → ongoing
- Decision date (initial)
- 2024-04-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Region Skåne (OFRS-medel)
External identifiers
- EU CT number
- 2023-509727-40-00
- ClinicalTrials.gov
- NCT05059418
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
The project will be divided into two studies:
The objective of the sub-studies will be:
1. Investigate the effect of topical treatment with clonazepam on pain intensity,
Consequences of pain, sensory changes and jaw function in patients
with BMS for two weeks. In particular, patients' own preference,
experience of the treatment will be studied in relation to
respective treatment effect.
2. Long-term follow-up (6 months) of treatment with clonazepam or control where the participants blindly choose the preferred treatment. All the factors examined in the first
study will be followed up.
Secondary objectives 1
- The effect of topical treatment with clonazepam in relation to somatosensory changes, taste changes, and salivary flow rate prior to and after treatment.
Conditions and MedDRA coding
Burning mouth syndrome
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Diagnosis BMS according to International Classification of Orofacial Pain (ICOP)
Exclusion criteria 1
- Se exklusionskriterier i protokollet
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Pain intensity [ Time Frame: will be assessed immediately before start of treatment as well as one, two and three weeks after treatment start ] Overall oral mucosa pain intensity. Will be assessed using the subscale "Characteristic pain intensity" (three numerical rating scales 0 - 10 assessing current pain. intensity as well as worst and average pain intensity during the last two weeks) in the Graded Chronic Pain Scale
- Patient global impression of change (PGIC)
- Pain related disability
Secondary endpoints 4
- Somatosensory changes including taste changes
- Jaw function limitation using JFLS-20
- Stress using PSS-10
- Pain catastrophizing using PCS
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB06728MIG · Substance
- Active substance
- Clonazepam
- Pharmaceutical form
- TABLET
- Route of administration
- TOPICAL
- Max daily dose
- 1.5 mg milligram(s)
- Max total dose
- 0.5 mg milligram(s)
- Max treatment duration
- 26 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Produkten i sig är inte modifierad utan endast administrationen, där topikal användning studeras istället för systemisk användning.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Malmoe Universitet
- Sponsor organisation
- Malmoe Universitet
- Address
- Bassanggatan 2
- City
- Malmo
- Postcode
- 211 19
- Country
- Sweden
Scientific contact point
- Organisation
- Malmoe Universitet
- Contact name
- Odontologiska Fakulteten
Public contact point
- Organisation
- Malmoe Universitet
- Contact name
- Odontologiska Fakulteten
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Sweden | 2025-06-16 | 2025-06-20 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-23 | Sweden | Acceptable 2024-04-10
|
2024-04-22 |