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

• Status: Not yet recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluate erenumab- aooe efficacy as a therapeutic approach, for the management of painful chronic temporomandibular disorders (TMD).

The study will be a randomized, double blind, placebo-controlled trial comparing erenumab-aooe vs Placebo.

A total of 60 patients (30 per each arm) aged 18-65 years old of either sex, and any race or ethnicity presenting chronic temporomandibular disorders (TMD), (meeting the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications of chronic TMD (myalgia +/- arthralgia) will be randomly assigned in a 1:1 parallel, double-blind clinical trial, to receive either erenumab-aooe or placebo. Participants will attend 6 clinic visits (Visit 0-Visit 5) over a period of 21 weeks (20 +/- 1 weeks). Changes in pain intensity and other pain outcomes related to TMD will be assessed. Blood samples will be collected, and participants will need to keep a daily symptom diary and answer some other questionnaires.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland, Baltimore
• Collaborator: Amgen
• Treatments: Erenumab

Criteria

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

Exclusion Criteria:

1. Participants with a history of congestive heart failure, rheumatoid arthritis or uncontrolled diabetes.

2. Participants with serious hepatic, respiratory, hematologic or immunologic illnesses, an unstable cardiovascular disease, or any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or Erenumab or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the participant inappropriate for entry into this trial

3. Participants with high blood pressure, history of abnormal electrocardiograms, history of heart conductance defects, malignant disease, chronic constipation, IBSc or any other severe acute or chronic medical or psychiatric condition or laboratory finding that may increase the risk associated with trial participation with Erenumab

4. Participants with active malignancy of any type or a history a malignancy (with exception of participants with malignancy surgically removed with no evidence of recurrence within 5 years before enrollment.

5. History of facial trauma or orofacial or orthognathic surgery within the previous 6 months

6. Patients with dental pain

7. Patients with trigeminal neuralgia or other neuropathic pain in the craniofacial area

8. Patients with degenerative joint disease in the TMJs, rheumatoid arthritis or any systemic arthritis

9. Patients with chronic migraine with and w/o aura following the ICHD-3 criteria treated or not treated with medication

• Without excluding headache attributed to TMD

10. Participants currently taking or have previously taken Erenumab or other CGRP monoclonal antibody (mAmb) or currently taking a CGRP-Receptor antagonist (gepants) for migraine prevention. CGRP-Receptor antagonist (gepants) for acute use for migraine are allowed.

11. Patients with hypersensitivity to Erenumab

12. Patients who have received the Botox injection protocol in the masseters and/or Migraine protocol within 3 months prior screening and baseline visit.

13. Used injections for management of TMD (trigger point injections, steroid injections) within 2 weeks prior to the Screening and Baseline Visit

14. Has commenced a new daily prescription medication for the management of pain within 30 days prior to the Screening and Baseline Visit

15. Has commenced intraoral appliance therapy for the management of facial pain within 30 days prior to the Screening and Baseline Visit

16. Patient currently undergoing active orthodontic treatment (passive retainers are permitted)

17. Treatment for drug or alcohol abuse within the last year

18. Has been treated with another investigational drug or treatment within 30 days prior to the Screening and Baseline Visit

19. Patients sensitive to Latex

20. Patient is pregnant, planning to become pregnant or breastfeeding

21. Anything that, in the opinion of the investigator, would place the participant at increased risk or impede the participant's full compliance with or completion of the study.