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NCT04884763 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Erenumab-aooe in Patients With Temporomandibular Disorder
A Phase 2 study of Temporomandibular Disorder, sponsored by Indiana University.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04884763: Completed Phase 2 study of Temporomandibular Disorder, sponsored by Indiana University.
NCT04884763 is a Phase 2 study of Temporomandibular Disorder that has completed, run by Indiana University. The registered enrollment target is 30 participants, below the 147-participant average among 3 other Temporomandibular Disorder trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04884763, a Phase 2 study of Temporomandibular Disorder, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Assessment of pain severity using the Brief Pain Inventory (BPI) 4-item pain severity scale at 20 weeks: 0 (Better) - 10 (Worse). Interim assessments were performed at 4, 8, 12 and 16 weeks and post-treatment at 24 weeks (secondary outcome).
Conditions Studied
Interventions
- DRUG Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments
- DRUG Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments
Study Locations (1)
Indiana
- Indiana University School of Dentistry, Oral Health Research Institute - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-11-15 |
| Est. Completion | 2024-01-04 |
| Phase | Phase 2 |
What the finished NCT04884763 record still lists
NCT04884763 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 147-participant average among 3 other Temporomandibular Disorder trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Temporomandibular Disorder appearing as the primary indexed condition, and to 2 interventions - of which Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments is the first listed.
NCT04884763 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT04884763 about?
NCT04884763 is a clinical study titled "Safety and Efficacy of Erenumab-aooe in Patients With Temporomandibular Disorder". 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.
What is the current status of trial NCT04884763?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2021-11-15. Estimated completion is 2024-01-04.
What conditions does trial NCT04884763 study?
This clinical trial studies the following conditions: Temporomandibular Disorder.
What interventions are being tested in trial NCT04884763?
The interventions under investigation include: Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments (DRUG), Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments (DRUG).
Who is sponsoring clinical trial NCT04884763?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04884763 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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