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Monoclonal Antibodies

Erenumab-aooe for Temporomandibular Joint Disorder (TMD CARE Trial)

Phase 2
Waitlist Available
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 0 (baseline/study day 0) to visit 5/week 20 (study day 140 +/- 7)
Awards & highlights

TMD CARE Trial Summary

This trial will compare the efficacy of erenumab-aooe to placebo in reducing pain intensity in adults with chronic TMD.

Eligible Conditions
  • Temporomandibular Joint Disorder (TMJ Disorder)

TMD CARE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 0 (baseline/study day 0) to visit 5/week 20 (study day 140 +/- 7)
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 0 (baseline/study day 0) to visit 5/week 20 (study day 140 +/- 7) 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 of >= 30% Reduction in the Monthly Average Pain Score From Baseline to Visit 4, Compared to Placebo.
Secondary outcome measures
Change in Graded Chronic Pain Scale (GCPS) Outcomes During Erenumab-aooe Treatment, After Treatment and Compared to Placebo.
Change in Impression of Overall Status Measured by the Patient Global Impression of Change (PGIC) During Erenumab-aooe Treatment, After Treatment and Compared to Placebo.
Change in Maximum Assisted/Active Opening During Erenumab-aooe Treatment, After Treatment and Compared to Placebo.
+12 more
Other outcome measures
Change of Pro-inflammatory and Anti-inflammatory Cytokine Profiles (Th1/Th2) When Compared to Placebo.

TMD CARE Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Erenumab-aooeActive Control1 Intervention
Erenumab-aooe 70 mg/ml. Subcutaneous injection. Administered once every 4 weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles. Other Name: Aimovig®
Group II: PlaceboPlacebo Group1 Intervention
Placebo. Subcutaneous injection.Administered once every 4 weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles. Other name: Placebo

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
687 Previous Clinical Trials
374,641 Total Patients Enrolled
AmgenIndustry Sponsor
1,370 Previous Clinical Trials
1,377,683 Total Patients Enrolled

Frequently Asked Questions

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

How many participants is the research team recruiting for this investigation?

"Indeed, the information found on clinicaltrials.gov indicates that this experiment is actively enrolling volunteers. It was initially posted on April 1st 2022 and last updated May 4th 2022 with a target of 60 participants at one medical site."

Answered by AI

Does this clinical experimentation represent a pioneering breakthrough?

"Amgen's Erenumab-aooe has been the subject of 18 live clinical trials in 32 countries and 179 cities since its Phase 3 approval trial, sponsored by Amgen, concluded with 456 participants back in 2019. Since then, an additional 18338 studies have been completed regarding this medication."

Answered by AI

Has Erenumab-aooe been tested in any prior research endeavors?

"Presently, 18 clinical trials are underway exploring the efficacy of Erenumab-aooe. Of those studies, 3 have advanced to the Phase 3 stage. While Rochester, Minnesota is home to many of these investigations, there are 549 other locations running experiments with this medication."

Answered by AI

Has the Food and Drug Administration authorized Erenumab-aooe for commercial distribution?

"Our assessment of erenumab-aooe's safety resulted in a score of 2, since there is current evidence attesting to its security but no established data on effectiveness."

Answered by AI

Who qualifies to participate in this clinical exploration?

"This medical trial is recruiting sixty individuals - aged 18 to 65 - with temporomandibular disorders. Other eligibility requirements for participation include: meeting two criteria concerning facial pain, consenting to the clinical trial, being compliant 80% of the time in their daily symptom diary within the baseline period and reporting an average pain level ≥30 on a numerical rating scale (0-100), discontinuing use of OTC medications prior to screening and baseline visit, allowing episodic or daily usage of short-acting non-prescription analgesics such as NSAIDs, acetaminophen, or aspirin during the study."

Answered by AI

Is this research endeavor actively recruiting participants?

"According to clinicaltrials.gov, this medical study is actively recruiting patients. The trial began advertising on April 1st 2022 and the latest update was posted on May 4th 2022."

Answered by AI

Does this experiment have an age restriction, and if so, is it over 45?

"The enrollment criteria for this trial necessitates that participants are of legal age and not yet retired."

Answered by AI
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~2 spots leftby Apr 2025