CompletedPhase 2

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

United States30 participantsStarted 2021-11-15

Plain-language 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.

Who can participate

Age range18 Years – 59 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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 criteria

✕. 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;

What they're measuring

Brief Pain Inventory (BPI) Pain Severity at 20 Weeks

Timeframe: 20 weeks.

Trial details

NCT IDNCT04884763

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-04

Results submitted2025-02-17

View on ClinicalTrials.gov More Temporomandibular Disorder trials