CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS for Temporomandibular disorder

Inclusion criteria

• {"criterion_text":"- a) Female gender\n- b) age 18-45 years\n- c) diagnos of myalgia, myofacial pain or myofascial pain with refered pain according to DC/TMD\n- d) an average pain due to NRS ≥ 3 for more than three months\n- e) treatment for orofacial pain > three months ago.\n- 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

• {"criterion_text":"- 1) treatment with BTX during the last six months\n- 2) treatment for orofacial pain within the last 3 months.\n- 3) systemic inflammatory diseases (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis)\n- 4) fibromyalgia\n- 5) neuropathic pain\n- 6) neurologic disease (myastenia gravis)\n- 7) pain of dental origin\n- 8) use of muscle relaxants or aminoglycoside antibiotics\n- 9) pregnancy or nursing\n- 10) hypersensitivity to BTX\n- 11) neuropsychiatric conditions.\n- 12) difficulties understanding the Swedish language.\n- 13) Trauma to head, neck or face, including orthognatic surgery"}

Primary endpoints

• {"endpoint_text":"- Changes in pain and if the dose matters for pain relief is the primary outcome.","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":""}

Sweden

Earliest CTIS Part Ii Submission Date

17-01-2024

Latest Decision Or Authorization Date

05-02-2024

Processing Time Days

19

Number Of Sites

1

Number Of Participants

1

Primary sponsor

Full Name

Region Stockholm Folktandvarden

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden