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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 is a Phase 2 study that was terminated before completion, run by University of Maryland, Baltimore. The registered enrollment target is 5 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05162027
The ClinicalTrials.gov registry entry for NCT05162027 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05162027 reports 0 study locations.
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.
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