Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
40
Countries
1
Sites
1
Myogenous temporomandibular disorders (TMDM)
To investigate if treatment with BTX alter gene expressions, epigenetic signatures, and cells plasticity in the masseter muscle of patients with TMDM
Key facts
- Sponsor
- Karolinska Institutet
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 20 Jun 2024 → ongoing
- Decision date (initial)
- 2024-06-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514739-12-00
- EudraCT number
- 2022-002999-37
- ClinicalTrials.gov
- NCT05720065
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To investigate if treatment with BTX alter gene expressions, epigenetic signatures, and cells plasticity in the masseter muscle of patients with TMDM
Secondary objectives 1
- To assess the effects by BTX on pain characteristics (intensity, frequency, and sensibility) and other variables in patients with TMDM as well as correlations between significantly changed expression of biomarkers and other variables
Conditions and MedDRA coding
Myogenous temporomandibular disorders (TMDM)
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | PR1 Test drug (botulinum toxin)
|
Randomised Controlled | Double | [{"id":63323,"code":2,"name":"Investigator"},{"id":63322,"code":1,"name":"Subject"}] | PR2: Comparator (isotonic saline) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- A diagnosis of myalgia or myofascial pain with referral according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) axix I
- Female aged 20 – 45 years
- A characteristic pain intensity of > 40/100
- Pain upon digital palpation of at least one of the masseter muscles
Exclusion criteria 14
- Difficulties understanding the Swedish language
- Systemic inflammatory connective tissue diseases (e.g. rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) c) widespread pain (e.g. fibromyalgia)
- Widespread pain (e.g. fibromyalgia)
- Neuromuscular disorders (e.g. craniomandibular dystonia, myasthenia gravis)
- Diagnosed or severe psychiatric disease (e.g. schizophrenia, bipolar disorder)
- Neuropathic pain
- Pain of dental origin
- History of trauma to the face, head or neck (incl. orthognathic surgery)
- Pregnancy or nursing
- Known allergy to botulinum toxin or antibiotics
- Use of muscle relaxants, antidepressant, neuropsychiatric, or anticoagulant drugs
- Use of analgesic or anti-inflammatory medication during the 48 hours preceding biopsy
- Previous treatment with BTX during the last 12 months
- Infection at the injection site
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The change of gene expressions, epigenetic signatures, and cells plasticity in the masseter muscle
Secondary endpoints 1
- The change of jaw muscle pain intensity after treatment
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
—
SCP1061961 · ATC
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 100 U unit(s)
- Max total dose
- 100 U unit(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01 — BOTULINUM TOXIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
-
V07AB · Product
- Pharmaceutical form
- PHF00017MIG
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 1 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Karolinska Institutet
- Sponsor organisation
- Karolinska Institutet
- Address
- Nobels Vag 6
- City
- Solna
- Postcode
- 171 65
- Country
- Sweden
Scientific contact point
- Organisation
- Karolinska Institutet
- Contact name
- Malin Ernberg
Public contact point
- Organisation
- Karolinska Institutet
- Contact name
- Malin Ernberg
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 40 | 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 | 2024-06-20 | 2024-06-20 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-10 | Sweden | Acceptable 2024-06-20
|
2024-06-20 |