CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments +1 moredrug
Likely dose
Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatmentsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04884763
NCT04884763Phase 2Completed
CompareCT.gov

A Randomized, Double Blind, Placebo-Controlled Single Center Phase 2 Pilot Study to Assess the Safety and Efficacy of Off-label Subcutaneous Administration of Erenumab-aooe in Patients With Temporomandibular Disorder

Indiana University·interventional·Posted May 13, 2021·Updated Aug 19, 2025

In Brief

A Phase 2 clinical trial evaluating Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments and Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments for Temporomandibular Disorder. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTemporomandibular Disorder
CountriesUnited States
CollaboratorsAmgen

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedMay 13, 2021
Enrollment StartNov 15, 2021
Primary CompletionJan 4, 2024
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.1 years ago

Interventions

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

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

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

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