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NCT05162027 · ClinicalTrials.gov registry record · Phase 2
Erenumab-aooe for Temporomandibular Disorders Management: TMD Cgrp Antibody RElief (TMD CARE)
A Phase 2 study, sponsored by University of Maryland, Baltimore.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT05162027: Clinical Trial Phase 2 study, sponsored by University of Maryland, Baltimore.
NCT05162027 is a Phase 2 study that was terminated before completion, run by University of Maryland, Baltimore. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05162027, a Phase 2 study, was terminated before completion, sponsored by University of Maryland, Baltimore.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
Evaluate erenumab- aooe efficacy as a therapeutic approach, for the management of painful chronic temporomandibular disorders (TMD). The study will be a randomized, double blind, placebo-controlled trial comparing erenumab-aooe vs Placebo. A total of 60 patients (30 per each arm) aged 18-65 years old of either sex, and any race or ethnicity presenting chronic temporomandibular disorders (TMD), (meeting the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications of chronic TMD (myalgia +/- arthralgia) will be randomly assigned in a 1:1 parallel, double-blind clinical trial, to receive either erenumab-aooe or placebo. Participants will attend 6 clinic visits (Visit 0-Visit 5) over a period of 21 weeks (20 +/- 1 weeks). Changes in pain intensity and other pain outcomes related to TMD will be assessed. Blood samples will be collected, and participants will need to keep a daily symptom diary and answer some other questionnaires.
Primary Outcome
Assessment of the efficacy of erenumab-aooe in the proportion of participants that achieve \>=30% reduction (Yes/no) in monthly average pain score from baseline to Visit 4 (the end of last monthly treatment cycle), compared to placebo. The daily pain intensity score will be measured on a 0-100 numeric rating scale (NRS) and reported in the Daily Symptom Diary (DSD). The monthly mean pain intensity score will be determined from baseline, Visit 1/Day 28/Week 4, Visit 2/Day 56/Week 8, Visit 3/Day 8
Interventions
- DRUG Placebo
- DRUG Erenumab-Aooe 70 MG in 1 mL Prefilled Syringe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2022-05-26 |
| Est. Completion | 2023-01-03 |
| Phase | Phase 2 |
Why NCT05162027 stopped before completion
NCT05162027 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05162027 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05162027 about?
NCT05162027 is a clinical study titled "Erenumab-aooe for Temporomandibular Disorders Management: TMD Cgrp Antibody RElief (TMD CARE)". Evaluate erenumab- aooe efficacy as a therapeutic approach, for the management of painful chronic temporomandibular disorders (TMD). The study will be a randomized, double blind, placebo-controlled trial comparing erenumab-aooe vs Placebo. A total of 60 patients (30 per each arm) aged 18-65 years ...
What is the current status of trial NCT05162027?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2022-05-26. Estimated completion is 2023-01-03.
What interventions are being tested in trial NCT05162027?
The interventions under investigation include: Placebo (DRUG), Erenumab-Aooe 70 MG in 1 mL Prefilled Syringe (DRUG).
Who is sponsoring clinical trial NCT05162027?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05162027's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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