Intratympanic Steroid for Bell's Palsy

NCT03508440 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2007139
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Bell's Palsy; Facial Nerve Paresis

Outcome Measures

Primary Outcomes (1)

• Facial Nerve Recovery

  Time (in days) from the diagnosis or start of treatment to complete recovery of paralysis, defined as house brackman score of 1

  Up to 365 days

Study Arms (3)

Standard of Care

ACTIVE COMPARATOR

Oral steroids (prednisone or prednisolone) 60mg per day for 10 days or 60mg/day for 5 days followed by a 5 day taper

Drug: Prednisone

SOC + injection

EXPERIMENTAL

Oral steroids as described above + intratympanic injection of dexamethasone (up to 1cc of 24mg/ml) - 3 injections over three weeks.

Procedure: Intratympanic injection; Drug: Prednisone

Injection only

OTHER

Only Intratympanic injection of dexamethasone (up to 1cc of 24mg/ml) - 3 injections over three weeks

Procedure: Intratympanic injection

Interventions

Intratympanic injection PROCEDURE

Injection will be up to 1cc of dexamethasone 24mg/mL. The procedure will be performed at supine position under a microscope. Local anesthesia will be achieved with topical phenol. A myringotomy will be made in the tympanic membrane. A 1 mL syringe connected to a needle will be used to slowly inject between 0.2 cc and 1.0 cc of solution through the myringotomy, with the subject's head turned 45 degrees to the opposite side. The subject will be asked to maintain positioning for at least 30 minutes and refrain from swallowing. The dose administered will vary due to subject-specific factors.

Injection only; SOC + injection

Prednisone DRUG

Oral Steroid

Also known as: Prednisolone

SOC + injection; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English as primary language
• Acute unilateral facial palsy without skin lesions which developed within a 72-hour period and is present for 21 days or less.
• Moderate to severe facial palsy \[House-Brackmann grade IV or greater\]

You may not qualify if:

• Another cause of facial nerve paralysis that is not idiopathic
• Otologic disease including otitis media, temporal bone fracture, a previous history of facial nerve palsy in either side, history of otologic surgery, and suspected Ramsay Hunt syndrome.
• Systemic disease including history of tuberculosis, history of head and neck cancer, other neurological disorders, recent use of ototoxic medications, liver or renal dysfunction, and other illnesses that would contraindicate the use of high-dose steroid therapy.
• Pregnancy

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Bell Palsy

Interventions

Injection, Intratympanic; Prednisone; Prednisolone

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Mouth Diseases; Stomatognathic Diseases; Facial Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols

Results Point of Contact

• Title: Rebecca Schneider, Assistant Director of Research
• Organization: University of Missouri

schneiderri@health.missouri.edu

573-882-2549

Study Officials

• Arnaldo Rivera, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There is no masking available as subject will know if they are receiving an intratympanic injection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: One arm will receive standard of care (SOC) in the form of high dose oral steroids for 10 days. The second arm will receive SOC plus 3 intratympanic steroid injections (space 7 days apart). Arm 3 is for patients who can not, for medical reasons, receive SOC; these patients will receive 3 intratympanic steroid injections (space 7 days apart).

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: April 25, 2018
• Study Start: January 31, 2018
• Primary Completion: November 22, 2022
• Study Completion: June 1, 2023
• Last Updated: November 5, 2024
• Results First Posted: November 5, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)