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

  • End date
    Apr 14, 2025
  • participants needed
  • sponsor
    University of Maryland, Baltimore
Updated on 14 May 2022


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.


Chronic TMD is a considerable burden and affects significantly the quality of life of the sufferer. For some patients, TMD has a tendency to remit or improve pain symptomatology over time but for others, TMD have the potential to become chronic and to lead to persistent dysfunction.

Different classes of medications from anti-inflammatories, muscle relaxants, anxiolytics, antidepressants, anticonvulsants and a β-blocker have indicated to be beneficial for some patients as well as in clinical studies, but tolerability and side effects may be present for some patients. Furthermore, the indications of these drugs are for other disorders, so it is unclear their mechanism of action in TMD pathophysiology. Currently there is no medication specifically indicated for the management of TMD based on its molecular pathophysiology. However, there is evidence showing that CGRP has a role in TMD pathophysiology. CGRP is a key molecule in migraine pathophysiology. Erenumab-aooe is the first antibody therapeutic targeting the CGRP and has shown efficacy, to be well tolerated and with a safety profile similar to placebo for the prevention of migraine. The scientific premise for this study is that inhibiting CGRP in chronic TMD will decrease pain, pain related outcomes and improve TMJ biomechanics (function) in a safe and well tolerated manner for this patient population.

Potential participants will be pre-screened at the Brotman Facial Pain clinic and the Oral and Maxillofacial Surgery Clinic both at the University of Maryland, School of Dentistry or by telephone; those willing to participate will be scheduled for a screening and baseline visit (Visit 0). During this visit potential participants will be evaluated for eligibility (meeting the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications) of chronic TMD (myalgia +/- arthralgia) and written informed consent will be obtained.

The screening and baseline procedures include medical history review, clinical examinations, tests and administration of questionnaires. After screening, eligible participants will start Visit 0/Day 0 which is the start of the baseline period with a duration of 28 days/4 weeks. Instructions will be given for the completion of a Daily Symptom Diary (DSD) and other questionnaires at home or online. Participants who show 80% compliance with the DSD and who meet the pain score (inclusion criteria) during the baseline period, will be randomly assigned to one of two groups either the investigational drug or placebo and will be scheduled for Visit 1. Visit 1 can occur within 7 days/1 week after the baseline period (+/- 7 days).

The study drug is erenumab-aooe 70mg, SC injection. Participants will attend 6 clinic visits (Visit 0-Visit 5) over a period of 21 weeks (20 +/- 1 weeks) or 140 +/- 7 days. After randomization and on Visit 1 (Week 4/Day 28), the participant will receive the drug or placebo. This same treatment will be administered once a month for 3 months (3 cycles/12 weeks). It will be administered on Visit 1/Day 28/Week 4; Visit 2/Day 56/Week 8; and Visit 3/Day 84/week 12. On Visit 0 (baseline) and on Visit 1, Visit 2, Visit 3, Visit 4/Day 112/Week 16 and visit 5/Day 140/Week 20, visits will include review of compliance with inclusion criteria, medical history review, review and collection of any adverse event, clinical examinations, questionnaires, tests, blood sample collection on Baseline/Visit 0 and Visit 4; and instruction to complete the DSD and questionnaires.

Condition Temporomandibular Disorders
Treatment Placebo, Erenumab-Aooe 70 MG in 1 mL Prefilled Syringe
Clinical Study IdentifierNCT05162027
SponsorUniversity of Maryland, Baltimore
Last Modified on14 May 2022


How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note