Clinical trial • Phase IV • Musculoskeletal
Botulinum toxin (ATC M03AX01) for Myogenous temporomandibular disorders (TMDM)
Phase IV trial of Botulinum toxin (ATC M03AX01) for Myogenous temporomandibular disorders (TMDM). Randomised, comparator (isotonic saline)-controlled.
Overview
- Trial Therapeutic Area
- Musculoskeletal
- Trial Disease
- Myogenous temporomandibular disorders (TMDM)
- Trial Stage
- Phase IV
- Drug Modality
- Peptide/protein/enzyme|Other
Key dates
- Initial CTIS Submission Date
- 10-06-2024
- First CTIS Authorization Date
- 20-06-2024
Trial design
Randomised, comparator (isotonic saline)-controlled Phase IV trial across 1 site in Sweden.
- Randomised
- Yes
- Comparator
- Comparator (isotonic saline)
- Target Sample Size
- 40
Eligibility
Recruits 40 Vulnerable population selected (isVulnerablePopulationSelected = true). No further information on consent/assent procedures is provided in the record..
- Pregnancy Exclusion
- Pregnancy or nursing
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). No further information on consent/assent procedures is provided in the record.
Inclusion criteria
- {"criterion_text":"- A diagnosis of myalgia or myofascial pain with referral according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) axix I\n- Female aged 20 – 45 years\n- A characteristic pain intensity of > 40/100\n- Pain upon digital palpation of at least one of the masseter muscles"}
Exclusion criteria
- {"criterion_text":"- Difficulties understanding the Swedish language\n- Known allergy to botulinum toxin or antibiotics\n- Use of muscle relaxants, antidepressant, neuropsychiatric, or anticoagulant drugs\n- Use of analgesic or anti-inflammatory medication during the 48 hours preceding biopsy\n- Previous treatment with BTX during the last 12 months\n- Infection at the injection site\n- Systemic inflammatory connective tissue diseases (e.g. rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) c) widespread pain (e.g. fibromyalgia)\n- Widespread pain (e.g. fibromyalgia)\n- Neuromuscular disorders (e.g. craniomandibular dystonia, myasthenia gravis)\n- Diagnosed or severe psychiatric disease (e.g. schizophrenia, bipolar disorder)\n- Neuropathic pain\n- Pain of dental origin\n- History of trauma to the face, head or neck (incl. orthognathic surgery)\n- Pregnancy or nursing"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The change of gene expressions, epigenetic signatures, and cells plasticity in the masseter muscle","definition_or_measurement_approach":"No specific definition or measurement approach provided in the record."}
Secondary endpoints
- {"endpoint_text":"- The change of jaw muscle pain intensity after treatment","definition_or_measurement_approach":"No specific definition or measurement approach provided in the record."}
Recruitment
- Planned Sample Size
- 40
- Recruitment Window Months
- 17
- Consent Approach
- Not specified. An exclusion criterion 'Difficulties understanding the Swedish language' is listed, implying consent will be conducted in Swedish; no details on assent, age-specific documents or languages are provided.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 40
Sweden
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 20-06-2024
- Processing Time Days
- 17
- Number Of Sites
- 1
- Number Of Participants
- 40
Sites
- Site Name
- Alfred Nobels Alle 8, Flemingsberg
- Department Name
- Department of Dental Medicine
- Principal Investigator Name
- Malin Ernberg
- Principal Investigator Email
- malin.ernberg@ki.se
- Contact Person Name
- Malin Ernberg
- Contact Person Email
- malin.ernberg@ki.se
- Number Of Participants
- 40
Sponsor
Primary sponsor
- Full Name
- Karolinska Institutet
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- BOTULINUM TOXIN
- Active Substance
- Botulinum toxin (ATC M03AX01)
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAMUSCULAR INJECTION
- Route
- Intramuscular injection
- Authorisation Status
- prodAuthStatus=2; marketingAuthorisationNumber='-'
- Maximum Dose
- 100 U unit(s)
- Investigational Product Name
- Isotonic saline (comparator solution)
- Active Substance
- -
- Modality
- Other
- Routes Of Administration
- INTRAMUSCULAR INJECTION
- Route
- Intramuscular injection
- Authorisation Status
- prodAuthStatus=2; miaNumber=11123; marketingAuthorisationNumber='-'
- Starting Dose
- 1 ml
- Dose Levels
- 1 ml
- Maximum Dose
- 1 ml
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