What side effects are associated with this type of intervention?

Common treatments for Temporomandibular Joint Disorder (TMD) include NSAIDs, muscle relaxants, antidepressants, and anticonvulsants. These treatments can cause side effects such as gastrointestinal issues, drowsiness, and dizziness. Erenumab, a CGRP receptor inhibitor studied for TMD, typically has mild side effects like injection site reactions, constipation, and muscle cramps. Low-level laser therapy (LLLT) has minimal side effects but has not proven more effective than placebo.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for Temporomandibular Joint Disorder (TMD) similar to Aimovig® (Erenumab) in the provided context. Aimovig® is being studied off-label for TMD pain, but its primary approval is for migraine prevention. Generally, treatments for TMD include pain relievers, muscle relaxants, and physical therapy, but CGRP receptor inhibitors like Erenumab are not yet standard treatments for TMD.

What other types of research exist?

Promising novel alternatives to Aimovig® (Erenumab) for Temporomandibular Joint Disorder (TMD) patients include: 1) Etanercept, which has shown anti-inflammatory effects in TMJ arthritis; 2) Rimegepant, an oral CGRP receptor antagonist effective in migraine treatment; and 3) Ubrogepant, another CGRP receptor antagonist with proven efficacy in acute migraine treatment. These alternatives have demonstrated potential in managing pain and inflammation, which are key aspects of TMD.

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Monoclonal Antibodies

Aimovig for TMJ Dysfunction

Phase 2

Waitlist Available

Led By Harold C Avila, DDS, MS

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline visit through the week 20 visit and after 24 weeks (two months after the last treatment).

Summary

This trial is testing Aimovig®, a drug usually used for migraines, to see if it can reduce jaw muscle pain in people with Temporomandibular Disorder (TMD). The study focuses on patients diagnosed with TMD-related muscle pain. Aimovig® works by blocking a protein that causes pain signals, potentially helping to alleviate jaw pain. Aimovig (erenumab-aooe), codeveloped by Amgen and Novartis, has been recently approved for the prevention of migraines.

Who is the study for?

This trial is for adults aged 18 to 59 with Temporomandibular Disorder (TMD) pain who have been stable on their current pain medications for at least four weeks. Participants must understand English and be able to follow the study's procedures. They should have had TMD myalgia for six months or more.

What is being tested?

The trial tests Erenumab-aooe, an off-label drug, against a placebo in reducing TMD pain. Each participant receives either the drug or placebo as an injection under the skin every four weeks, five times during the study.

What are the potential side effects?

Possible side effects of Erenumab-aooe may include reactions at the injection site, constipation, muscle spasms or cramps, and potentially other symptoms not yet known due to its off-label use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline visit through the week 20 visit and after 24 weeks (two months after the last treatment).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline visit through the week 20 visit and after 24 weeks (two months after the last treatment).

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline visit through the week 20 visit and after 24 weeks (two months after the last treatment). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in mean between-group difference in pain using the Brief Pain Inventory

Secondary study objectives

Change in mean between-group difference in pain based on assessment depressive and anxiety symptoms

Change in mean between-group difference in pain based on assessment of days of use of TMD pain specific medication

Change in mean between-group difference in pain based on assessment of global improvement in pain

+5 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Arm AActive Control1 Intervention

Arm A: erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments

Group II: Arm BPlacebo Group1 Intervention

Arm B: placebo (EREN-P) s.c. administered every four weeks for a total of five treatments

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Erenumab, a CGRP receptor inhibitor, works by blocking the calcitonin gene-related peptide (CGRP) receptor, which is involved in the transmission of pain and the dilation of blood vessels. This mechanism is particularly relevant for Temporomandibular Joint Disorder (TMD) patients as CGRP is known to play a role in the pathophysiology of pain and inflammation associated with TMD. By inhibiting CGRP, Erenumab can potentially reduce pain and improve function in TMD patients. Other common treatments for TMD include physical therapy, which aims to improve jaw mobility and reduce pain through exercises and manual techniques, and prolotherapy, which involves injecting a solution to stimulate tissue repair and reduce pain. Understanding these mechanisms helps in tailoring treatment plans to effectively manage TMD symptoms.

Efficacy of hypertonic dextrose injection (prolotherapy) in temporomandibular joint dysfunction: a systematic review and meta-analysis.Outcomes of physical therapy in patients with temporomandibular disorder: a retrospective review.The treatment modalities of masticatory muscle pain a network meta-analysis.