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NCT03508440 · ClinicalTrials.gov registry record · Phase 2
Intratympanic Steroid for Bell's Palsy
A Phase 2 study of Bell's Palsy and Facial Nerve Paresis, sponsored by University of Missouri-Columbia.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT03508440 is a Phase 2 study of Bell's Palsy and Facial Nerve Paresis that has completed, run by University of Missouri-Columbia. The registered enrollment target is 10 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03508440, a Phase 2 study of Bell's Palsy and Facial Nerve Paresis, has completed, sponsored by University of Missouri-Columbia.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Facial nerve paralysis is due to inflammation around the facial nerve. Current treatment for facial nerve paralysis is a 10 day course of oral steroids (which will reduce the inflammation), with electrodiagnostic testing. There have been limited studies on the use of intratympanic steroid injection, in addition to oral steroid, in the recovery of facial nerve paralysis. There are indications that the use of intratympanic injections, in addition to the oral steroids, will speed up the recovery rate of the facial nerve paralysis, as well as improve the complete recovery of the facial nerve paralysis. This study will randomize patients with facial nerve paralysis into two groups: 1) oral steroid only and 2) oral steroid plus a 3 intratympanic steroid injections spaced out over three weeks. There are a subset of patients that are unable to take oral steroids for medical reasons (such as diabetes); these patients will be placed into a third group and only receive 3 intratympanic steroid injections space out over three weeks. Subjects that are to receive the intratympanic injection will receive pre- and post-hearing exams as part of their standard of care. Patients will be evaluated via videorecording by two blinded investigators as well as in person evaluations by the unblinded treating physician. Subjects will be followed until complete facial nerve paralysis recovery or one year post-treatment, whichever comes first.
Conditions Studied
Interventions
- DRUG Prednisone
- PROCEDURE Intratympanic injection
Study Locations (1)
Missouri
- University of Missouri - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2018-01-31 |
| Est. Completion | 2023-06-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03508440
The ClinicalTrials.gov registry entry for NCT03508440 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Bell's Palsy appearing as the primary indexed condition, and to 2 interventions - of which Prednisone is the first listed.
NCT03508440 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT03508440 about?
NCT03508440 is a clinical study titled "Intratympanic Steroid for Bell's Palsy". Facial nerve paralysis is due to inflammation around the facial nerve. Current treatment for facial nerve paralysis is a 10 day course of oral steroids (which will reduce the inflammation), with electrodiagnostic testing. There have been limited studies on the use of intratympanic steroid injection,...
What is the current status of trial NCT03508440?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2018-01-31. Estimated completion is 2023-06-01.
What conditions does trial NCT03508440 study?
This clinical trial studies the following conditions: Bell's Palsy, Facial Nerve Paresis.
What interventions are being tested in trial NCT03508440?
The interventions under investigation include: Prednisone (DRUG), Intratympanic injection (PROCEDURE).
Who is sponsoring clinical trial NCT03508440?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03508440 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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