Erenumab-aooe for Temporomandibular Disorders Management: TMD Cgrp Antibody RElief (TMD CARE)

Inclusion Criteria

• •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• •1. Provide signed and dated informed consent form
• •2. Is between 18 and 65 years of age (inclusive; male or female and any race or ethnicity)
• •3. Meets diagnostic criteria for TMD: Myalgia with or without arthralgia
• •• The participant must meet 2 criteria relating: 1) reported pain, ache or tenderness in the face, jaw/mandible, pre-auricular area, inside the ear or temple that it is modified by TMJ biomechanics. 2) finding(s) of TMD myalgia according to the classification DC/TMD criteria.
• •4. Has experienced facial pain and/or pain with TMJ biomechanics for the last 3 months episodically or unremitting
• •5. Has experienced facial pain for at least 10 days of the last 30 days prior to Baseline Visit (Visit 0)
• •6. Prior to randomization, has been compliant 80% with the entries in the Daily Symptom Diary within the baseline period and reported an average pain level ≥30 on a numerical rating scale (0-100) in the DSD, or has experienced a pain level ≥30 on the same scale for at least 3 days in the week prior to Visit 1.
• •7. If taking a prescription medication daily for the management of pain (taken for at least 30 days before baseline), agrees to continue the daily use of the medication throughout the study at the same dosage.
• •8. If taking prescription medication, opioid medication or OTC medications as needed or episodically for the management of TMD pain agrees to discontinue its use prior to the Screening and Baseline Visit.
• •* Rescue medications will be defined as allowable over-the-counter analgesics used for treatment of TMD pain. In case a patient presents pain during the study, only it is allowed the use of OTC medications as a "rescue" and as described on section 6.6.3: Participants use of short-acting non-prescription analgesics such as NSAIDs, acetaminophen or aspirin during the study, will be recorded and quantified at each visit, and the usage will be classified as either episodic or daily. Episodic use of non-prescription analgesics will be defined as use for no more than 2 consecutive days and for no more than 18 days from baseline to visit 4.
• •* This type of analgesics should not be used for more than 2 days a week prior to Baseline and a week prior to visit 4, when the exploratory outcome is assessed (cytokine release assay).
• •9. If taking OTC pain medications daily agrees to continue its daily use at the same dosage throughout the study.
• •• If a participant is taking an over-the-counter medication daily for management of other type of pain or for prophylaxis of myocardial infarction or stroke, the participant will be encouraged to continue the same usage of that medication throughout the study.
• •10. Agrees to not start any new prescription medication for the management of pain throughout the study
• •11. Agrees to not start any injection therapy for the management of TMD (trigger point injections, steroid injections, Botox) during the course of the study
• •12. Agrees to not use acupuncture for the management of pain during the course of the study
• •13. Agrees to not have Physical therapy for the management of TMD during the course of the study.
• •14. Agrees to not start intraoral appliance therapy during the course of the study. If the patient has used a nightguard for more than one month before the study, agrees to continue use it only at night.
• •15. Females of childbearing potential agree to use one of the following methods of contraception throughout the study: licensed hormonal method, intrauterine device, female or male condoms with contraceptive foam, abstinence, bilateral tubal ligation/occlusion, or vasectomy in partner (if postmenopausal, must not have menstruated for at least 12 consecutive months)
• •16. Willing and able to understand and comply with all study procedures and be available for the duration of the study