Safety and Efficacy of Erenumab-aooe in Patients With Temporomandibular Disorder (NCT04884763) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of Erenumab-aooe in Patients With Temporomandibular Disorder
United States30 participantsStarted 2021-11-15
Plain-language summary
The purpose of this proof of concept study is to evaluate the safety and efficacy of the off-label use of Aimovig® (EREN) in reducing Temporomandibular Disorder (TMD) pain compared to placebo.
Who can participate
Age range
18 Years – 59 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed the informed consent;
. Have pain-related TMD myalgia assessed by history and clinical examination as established by the DC/TMD;
. Age 18 years and younger than 60 years;
. Have a good knowledge of the English language;
. Able to understand and comply with the study requirements;
. Have had TMD myalgia for 6 months or longer; and
. If taking pain medications, the dose regimen must be stable for at least 4 weeks prior to the screening visit.
Exclusion criteria
. Lacking stable bilateral posterior occlusion;
. Currently uses a complete maxillary or mandibular prosthetic denture;
. Currently pregnant or plan to become pregnant;
. Breastfeeding or plan to breastfeed;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Brief Pain Inventory (BPI) Pain Severity at 20 Weeks