NCT06941636 Botulinumtoxin A as a Treatment for Myalgia and Myofacial Pain in Patient With Temporomandibulardisorders
| NCT ID | NCT06941636 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Region Stockholm |
| Condition | Temporomandibular Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 90 participants in total. It began in 2025-05-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Both patients and remitters ask for treatment with Botulinumtoxin A (BTX) with the hope that it will be an effective aid for pain, but little is known regarding if the effect is dose dependent. 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.
Eligibility Criteria
Inclusion Criteria: * Has given a written consent * Diagnose of myalgia, myofacial pain or myofascial pain with referred pain according * Average pain due to NRS ≥ 3 for more than three months * Palpationpain in masseter or temporalis. * Eventual treatment for orofacial pain \> three months ago. * Adequate contraceptives and a negative pregnancy test. Patients will still be included even if they have one or more co-diagnoses * Discdisplacement with or without reduction * Degenerative joint disease * Arthralgia Exclusion Criteria: * Treatment with BTX during the last 12 months * Treatment for orofacial pain within the last 3 months. * Systemic inflammatory diseases (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis) * Widespread pain e.g., fibromyalgia * Neuropathic pain * Neurologic disease (myasthenia gravis) * Pain of dental origin * Use of muscle relaxants, or aminoglycoside antibiotics * Pregnancy or nursing * Hypersensitivity to BTX * Neuropsychiatric conditions. * Difficulties understanding the Swedish language
Contact & Investigator
Veronica de Flon
PRINCIPAL INVESTIGATOR
Region Stockholm
Frequently Asked Questions
Who can join the NCT06941636 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Temporomandibular Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06941636 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 90 participants.
Is NCT06941636 currently recruiting?
Yes, NCT06941636 is actively recruiting participants. Contact the research team at veronica.deflon@regionstockholm.se for enrollment information.
Where is the NCT06941636 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT06941636 clinical trial?
NCT06941636 is sponsored by Region Stockholm. The principal investigator is Veronica de Flon at Region Stockholm. The trial plans to enroll 90 participants.