Status:
COMPLETED
Safety and Efficacy of Erenumab-aooe in Patients With Temporomandibular Disorder
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Amgen
Conditions:
Temporomandibular Disorder
Eligibility:
All Genders
18-59 years
Phase:
PHASE2
Brief 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.
Detailed Description
This will be a 24-week, randomized, double-blinded, placebo-controlled, parallel group proof-of-concept study with two arms (active and placebo). The plan is to enroll 30 subjects. There will be a fou...
Eligibility Criteria
Inclusion
- Subjects eligible for inclusion in the study must meet all of the following 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
- Subjects meeting any of the following criteria are not eligible for inclusion:
- 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;
- Allergic to erenumab-aooe or any of the ingredients in Aimovig® (acetate, polysorbate 80, and sucrose);
- Allergic to rubber or latex;
- Currently undergoing TMD treatment elsewhere;
- Currently undergoing orthodontic treatment;
- Currently included in other experimental protocols within the last 30 days before enrollment;
- Having 11 or more headaches during the past 4 weeks;
- Having received massage, acupuncture or physical therapy treatment of the head, neck or shoulders during the previous 3 months;
- History of unstable or acute severe pain from another pain condition;
- History of traumatic brain injury;
- History of surgical treatment or recommended surgical treatment for TMD;
- History of ongoing, unresolved disability litigation;
- History of drug abuse;
- History of moderate to severe sleep apnea requiring CPAP or oral mandibular repositioning appliance;
- Anything that would place the subjects at increased risk or preclude the individual's full compliance with or completion of the study (e.g., medical condition, laboratory finding, physical exam finding logistical complication); and
- History of previously receiving erenumab-aooe or other anti-CGRP therapies, including anti-CGRP and anti-CGRP receptor monoclonal antibodies and small molecule CGRP receptor antagonists (gepants).
- History of chronic constipation and/or using medication associated with decreased gastrointestinal motility.
- History of hypertension or risk factors for hypertension.
Key Trial Info
Start Date :
November 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04884763
Start Date
November 15 2021
End Date
January 4 2024
Last Update
August 19 2025
Active Locations (1)
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1
Indiana University School of Dentistry, Oral Health Research Institute
Indianapolis, Indiana, United States, 46202