Trial Outcomes & Findings for Intratympanic Steroid for Bell's Palsy (NCT NCT03508440)
NCT ID: NCT03508440
Last Updated: 2024-11-05
Results Overview
Time (in days) from the diagnosis or start of treatment to complete recovery of paralysis, defined as house brackman score of 1
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
10 participants
Primary outcome timeframe
Up to 365 days
Results posted on
2024-11-05
Participant Flow
Participant milestones
| Measure |
Standard of Care
Oral steroids (prednisone or prednisolone) 60mg per day for 10 days or 60mg/day for 5 days followed by a 5 day taper
Prednisone: Oral Steroid
|
SOC + Injection
Oral steroids as described above + intratympanic injection of dexamethasone (up to 1cc of 24mg/ml) - 3 injections over three weeks.
Intratympanic injection: 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.
Prednisone: Oral Steroid
|
Injection Only
Only Intratympanic injection of dexamethasone (up to 1cc of 24mg/ml) - 3 injections over three weeks
Intratympanic injection: 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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
9
|
0
|
|
Overall Study
COMPLETED
|
1
|
9
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard of Care
n=1 Participants
Oral steroids (prednisone or prednisolone) 60mg per day for 10 days or 60mg/day for 5 days followed by a 5 day taper
Prednisone: Oral Steroid
|
SOC + Injection
n=9 Participants
Oral steroids as described above + intratympanic injection of dexamethasone (up to 1cc of 24mg/ml) - 3 injections over three weeks.
Intratympanic injection: 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.
Prednisone: Oral Steroid
|
Injection Only
Only Intratympanic injection of dexamethasone (up to 1cc of 24mg/ml) - 3 injections over three weeks
Intratympanic injection: 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.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63 Years
STANDARD_DEVIATION 0 • n=1 Participants
|
52.90 Years
STANDARD_DEVIATION 13.836 • n=9 Participants
|
—
|
52.90 Years
STANDARD_DEVIATION 13.836 • n=10 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=1 Participants
|
2 Participants
n=9 Participants
|
—
|
3 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1 Participants
|
7 Participants
n=9 Participants
|
—
|
7 Participants
n=10 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
1 participants
n=1 Participants
|
9 participants
n=9 Participants
|
—
|
10 participants
n=10 Participants
|
|
House Brackman Score at Diagnosis
|
5 units on a scale
STANDARD_DEVIATION 0 • n=1 Participants
|
5.11 units on a scale
STANDARD_DEVIATION 0.928 • n=9 Participants
|
—
|
5.10 units on a scale
STANDARD_DEVIATION 0.876 • n=10 Participants
|
PRIMARY outcome
Timeframe: Up to 365 daysPopulation: Adults over the age of 18 that presented with Bell's palsy and a House Brackman score of 4 or greater
Time (in days) from the diagnosis or start of treatment to complete recovery of paralysis, defined as house brackman score of 1
Outcome measures
| Measure |
Standard of Care
n=1 Participants
Oral steroids (prednisone or prednisolone) 60mg per day for 10 days or 60mg/day for 5 days followed by a 5 day taper
Prednisone: Oral Steroid
|
SOC + Injection
n=9 Participants
Oral steroids as described above + intratympanic injection of dexamethasone (up to 1cc of 24mg/ml) - 3 injections over three weeks.
Intratympanic injection: 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.
Prednisone: Oral Steroid
|
Injection Only
Only Intratympanic injection of dexamethasone (up to 1cc of 24mg/ml) - 3 injections over three weeks
Intratympanic injection: 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.
|
|---|---|---|---|
|
Facial Nerve Recovery
|
7 Days
Standard Deviation 0
|
81.56 Days
Standard Deviation 47.671
|
—
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SOC + Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Injection Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Rebecca Schneider, Assistant Director of Research
University of Missouri
Phone: 573-882-2549
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place