# A randomized, double blind, placebo-controlled pilot study to assess the efficacy of erenumab in individuals with temporomandibular disorder

## TL;DR

This study tested if erenumab, a drug for migraines, could also help with jaw pain from TMD but found no significant benefit.

## Contribution

First clinical trial to evaluate erenumab for TMD-related myalgia, an off-label use.

## Key findings

- Erenumab did not significantly reduce TMD-related pain compared to placebo.
- Depression and anxiety symptoms were slightly worse in the erenumab group.
- Five participants withdrew from the trial, mostly from the erenumab group.

## Abstract

Background: Erenumab has proven efficacious in treating migraine
headache. Temporomandibular disorder (TMD) is a painful disorder which has high
co-occurrence rates with migraine. We hypothesized that erenumab-aooe may also be
beneficial in reducing pain in TMD-related myalgia. Methods: This phase
II randomized placebo-controlled clinical trial evaluated the safety and efficacy
of the off-label use of erenumab in reducing TMD-related pain. The TMD diagnosis
was established using the Diagnostic Criteria for Temporomandibular Disorders.
The primary outcome was pain interference as assessed by the 0-to-10-point Brief
Pain Inventory (BPI). Secondary outcomes were depression, anxiety and somatic
symptoms; jaw function; and percent of days taking pain medication. Subjects were
randomized at baseline to receive either erenumab 140 mg or placebo administered
subcutaneously every 4 weeks for a total of five treatments. Outcome assessments
were conducted at baseline, 4, 8, 12, 16, 20 and 24 weeks. Results:
Thirty subjects were enrolled with 15 randomized to each treatment group.
Baseline pain was mild (BPI interference of 2.19; BPI severity of 2.95). There
were no significant treatment effects at any time points with the between-group
BPI interference at 24 weeks being −0.19 (95% confidence interval −1.94 to 1.56;
p = 0.82). The outcomes were similar between erenumab and placebo for
all outcomes except the Patient Health Questionnaire 4-item scale (PHQ-4) which
showed that depression/anxiety symptoms were modestly worse (p = 0.03)
in the erenumab group. Five participants withdrew during the trial (4 in erenumab
arm, 1 in placebo arm). Conclusions: Erenumab was not efficacious in
reducing TMD myalgic pain in this phase II trial of 30 subjects with relatively
mild pain. Clinical Trial Registration: The study was registered in
clinicaltrials.gov (ID: NCT04884763).