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Corticosteroid

Intratympanic injection for Bell's Palsy

Phase 2 & 3
Waitlist Available
Led By Arnaldo Rivera, MD
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial will help to determine if adding intratympanic steroid injections to the current standard of care oral steroids will help to improve the recovery rate of facial nerve paralysis.

Eligible Conditions
  • Bell's Palsy
  • Facial Palsy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Facial nerve recovery

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: SOC + injectionExperimental Treatment2 Interventions
Oral steroids as described above + intratympanic injection of dexamethasone (up to 1cc of 24mg/ml) - 3 injections over three weeks.
Group II: Injection onlyExperimental Treatment1 Intervention
Only Intratympanic injection of dexamethasone (up to 1cc of 24mg/ml) - 3 injections over three weeks
Group III: Standard of CareActive Control1 Intervention
Oral steroids (prednisone or prednisolone) 60mg per day for 10 days or 60mg/day for 5 days followed by a 5 day taper
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intratympanic injection
2018
Completed Phase 3
~20
Prednisolone
FDA approved

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor
362 Previous Clinical Trials
628,103 Total Patients Enrolled
Arnaldo Rivera, MDPrincipal InvestigatorUniversity of Missouri-Columbia
1 Previous Clinical Trials
382 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study build on previous research involving Intratympanic injection?

"As of now, there are 396 active studies and 115 trials in Phase 3 for Intratympanic injection. Most of the clinical trials are based in Duarte, California, but there are 16696 total locations for these trials."

Answered by AI

For what reasons is Intratympanic injection usually given?

"Intratympanic injection can be used as a form of treatment for multiple sclerosis, ulcerative colitis, and varicella-zoster virus acute retinal necrosis."

Answered by AI

Are new participants needed for this clinical trial?

"According to the official website, this clinical trial is still recruiting patients. The study was first posted on 1/31/2018 and was last edited on 4/12/2021."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
How old are they?
18 - 65
What site did they apply to?
University of Missouri
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Intratympanic Steroid for Bell's Palsy
Arnaldo L. Rivera 2018. "Intratympanic Steroid for Bell's Palsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03508440.
~2 spots leftby Apr 2025
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