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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

Have had TMD myalgia for 6 months or longer;

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).

Awards & highlights

Study Summary

This trial is testing if Aimovig can help with pain from Temporomandibular Disorder, and if it is safe.

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.Check my eligibility

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.See study design

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

You have experienced TMD myalgia for more than 6 months.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

983,131 Total Patients Enrolled

Novartis PharmaceuticalsIndustry Sponsor

2,855 Previous Clinical Trials

4,197,320 Total Patients Enrolled

Harold C Avila, DDS, MSPrincipal InvestigatorIndiana University

Media Library

Erenumab-aooe (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04884763 — Phase 2

Temporomandibular Joint Disorder Research Study Groups: Arm B, Arm A

Temporomandibular Joint Disorder Clinical Trial 2023: Erenumab-aooe Highlights & Side Effects. Trial Name: NCT04884763 — Phase 2

Erenumab-aooe (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04884763 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to be a subject of this experiment?

"Admission to this trial requires a diagnosis of temporomandibular joint dysfunction syndrome and being aged between 18 and 59. Currently, there are 30 spots available for prospective participants."

Answered by AI

Has Arm A obtained formal authorization from the Food and Drug Administration?

"There is some evidence confirming the safety of Arm A, so our team scored it a 2. This Phase 2 trial does not have any proof that this medication has efficacy."

Answered by AI

Is this investigation a pioneering endeavor?

"Since 2019, Arm A has been the focus of several research initiatives. First funded and sponsored by Amgen in 2019 with a trial population size of 456 participants, it was later approved for Phase 3 drug testing through additional studies conducted across 32 nations and 179 cities; as of now there are 18 active trials associated with this arm."

Answered by AI

Can individuals still join this research endeavor?

"According to clinicaltrials.gov, this research study is currently recruiting patients and was first posted on November 15th 2021 with its most recent update being March 17th 2022."

Answered by AI

What is the current cohort size for this clinical research?

"Affirmative. According to clinicaltrials.gov, this research study is still open for recruitment with an initial posting date of November 15th 2021 and its most recent edit on March 17 2022. The medical experiment requires 30 people at a single site."

Answered by AI

What past investigations have been undertaken involving Arm A?

"At the moment, 18 trials are running to investigate Arm A. Out of those studies, 3 are at a Phase 3 stage. While Rochester, Minnesota is home base for many of these explorations, there are 549 other medical centres studying this intervention."

Answered by AI