Overview
Sponsor-declared trial summary
Temporomandibular disorder
The aim of this project is to investigate if injections with BTX in the masseter- and temporal muscle is an efficient treatment in patient with myogenous temporomandibular disorders (TMD) and if the effect of BTX is dose dependent
Key facts
- Sponsor
- Region Stockholm Folktandvarden
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Stomatognathic Diseases [C07], Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 1 May 2025 → ongoing
- Decision date (initial)
- 2024-02-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Folktandvården Stockholm AB
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The aim of this project is to investigate if injections with BTX in the masseter- and temporal muscle is an efficient treatment in patient with myogenous temporomandibular disorders (TMD) and if the effect of BTX is dose dependent
Conditions and MedDRA coding
Temporomandibular disorder
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- a) Female gender b) age 18-45 years c) diagnos of myalgia, myofacial pain or myofascial pain with refered pain according to DC/TMD d) an average pain due to NRS ≥ 3 for more than three months e) treatment for orofacial pain > three months ago.f) with adequate contraceptives and a negative pregnancy test. Patients will still be included even if they have one or more co-diagnoses 1) Discdisplacement with or without reduction according to DC/TMD 2) degenerative joint disease 3) arthralgia
Exclusion criteria 1
- 1) treatment with BTX during the last six months 2) treatment for orofacial pain within the last 3 months. 3) systemic inflammatory diseases (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis) 4) fibromyalgia 5) neuropathic pain 6) neurologic disease (myastenia gravis) 7) pain of dental origin 8) use of muscle relaxants or aminoglycoside antibiotics 9) pregnancy or nursing 10) hypersensitivity to BTX 11) neuropsychiatric conditions.12) difficulties understanding the Swedish language.13) Trauma to head, neck or face, including orthognatic surgery
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Changes in pain and if the dose matters for pain relief is the primary outcome.
Secondary endpoints 1
- Changes in quality of life according to OHIP. Treatment outcome in sub-groups of myogenous TMD. Maximum jaw opening with and without pain between doses and subgroups. The patient´s changes psychosocially, how the jawfunction is affected according to changes in Axis II and changes in PPT.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Clostridium Botulinum Neurotoxin Type a (150KD), Free of Complexing Proteins
SUB26174 · Substance
- Active substance
- Clostridium Botulinum Neurotoxin Type a (150KD), Free of Complexing Proteins
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- DENTAL USE
- Max daily dose
- 100 U unit(s)
- Max total dose
- 100 U unit(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Stockholm Folktandvarden
- Sponsor organisation
- Region Stockholm Folktandvarden
- Address
- Magnus Ladulasgatan 65, Katarina Katarina
- City
- Stockholm
- Postcode
- 118 27
- Country
- Sweden
Scientific contact point
- Organisation
- Region Stockholm Folktandvarden
- Contact name
- clinical trial information desk
Public contact point
- Organisation
- Region Stockholm Folktandvarden
- Contact name
- clinical trial information desk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 1 | 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 | 2025-05-01 | 2025-05-01 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-26 | Sweden | Acceptable 2024-02-02
|
2024-02-05 |