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Safety and Efficacy of Erenumab-aooe in Patients With Temporomandibular Disorder

NCT04884763 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-19

Study results available
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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.

Conditions

  • Temporomandibular Disorder

Interventions

DRUG

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

Erenumab-aooe (EREN) 140 mg s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments

DRUG

Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments

Placebo (EREN-P) s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Indiana University

    lead OTHER

Principal Investigators

  • Domenick T Zero, DDS, MS · Indiana University

  • Harold C Avila, DDS, MS · Indiana University

  • Kurt Kroenke, MD, MACP · Regenstrief Institute, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2024-01-04
Completion
2024-01-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04884763 on ClinicalTrials.gov