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

TerminatedPhase 2NCT05162027
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Erenumab as a Therapeutic Approach for the Management of Painful Chronic Temporomandibular Disorders (TMD)
Interventions
Sponsor
University of Maryland, Baltimore
Collaborators
Amgen
Start date
2022-05-26
Primary completion
2023-01-03
Sex
All
Age range
from 18 Years to 65 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 throughou…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05162027