Sudden Deafness Treatment Trial

Phase 3

Completed

• Conditions: Sudden Deafness
• Interventions: Drug: methylprednisolone sodium succinate; Drug: prednisone

• Registration Number: NCT00097448
• Lead Sponsor: Massachusetts Eye and Ear Infirmary

Brief Summary

This trial aims to compare the efficacy of oral prednisone vs. methylprednisolone injected into the middle ear for the treatment of moderate-to-severe, sudden sensorineural hearing loss (inner ear hearing loss affecting one ear that occurs over less than 72 hours).

Detailed Description

Sudden deafness is believed to affect 1:5000 people yearly. The cause is unknown. Spontaneous improvement is seen in approximately 20% of subjects. Improvement is seen in approximately 60% of subjects treated promptly with oral corticosteroids. Anecdotal case reports and uncontrolled case series have suggested the intratympanic corticosteroids may work as well or better than oral treatment. The risks of oral prednisone are well-known. In theory, intratympanic treatment should achieve a higher drug concentration at the target (inner ear) with less risk of systemic side effects. This study is a head-to-head comparison of oral prednisone vs. intratympanic methylprednisolone for primary treatment of idiopathic sudden deafness. The study is designed as a non-inferiority trial testing that hypothesis that intratympanic methylprednisolone is not inferior to oral prednisone treatment. Subjects assigned to the oral treatment arm receive 14 days of high dose prednisone (60mg/day) followed by a 5-day taper. Subjects assigned to the intratympanic treatment arm receive 4 doses of methylprednisolone injected into the middle twice weekly for two weeks. The primary outcome measure is hearing as measured by pure tone audiometry. Secondary outcomes include word recognition hearing levels and safety issues of local vs. systemic steroid side-effects and pain.

Study Timeline

• Study First Submitted: 2004-11-23
• Study First Submitted QC: 2004-11-23
• Study First Posted: 2004-11-24
• Study Start: 2004-12
• Primary Completion: 2009-10
• Study Completion: 2011-03
• Results First Submitted: 2012-11-08
• Results First Submitted QC: 2013-02-27
• Results First Posted: 2013-04-04
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 255

Inclusion Criteria

• Men/women 18 years and older in good health
• Unilateral sensorineural hearing loss developing within 72 hours (SSNHL)
• Pure Tone Average (PTA) (500, 1000, 2000, 4000 Hz) >/= 50 dB in the affected ear, with the affected ear >/= 30 dB worse than contralateral ear in at least one of the four frequencies
• Symmetric hearing prior to onset of SSNHL
• Hearing loss must be idiopathic
• Hearing loss must have occurred within the past 14 days
• Must be able to read or write English or Spanish

Exclusion Criteria

SYSTEMIC DISEASE

• >21 days prior oral steroid treatment within preceding 30 days
• History of tuberculosis (TB) or positive PPD
• Insulin-dependent diabetes mellitus
• History of rheumatic disease, e.g., rheumatoid arthritis, scleroderma, lupus, etc.
• Serious psychiatric disease or psychiatric reaction to corticosteroids
• History of heart disease or transient ischemic attacks (TIAs)
• Prior treatment with chemotherapeutic or immunosuppressive drugs
• Pancreatitis
• Active peptic ulcer disease or history of gastrointestinal bleeding
• History of HIV, Hepatitis B or C
• Chronic kidney failure
• Alcohol abuse
• Active shingles
• Severe osteoporosis or non-surgical aseptic necrosis of the hip

OTOLOGIC DISEASE

• Prior history of SSNHL
• History of fluctuating hearing loss
• History of Meniere's disease
• History of chronic ear infection
• History of otosclerosis
• History of ear surgery (except childhood pressure equalization [pe] tubes)
• History of congenital hearing loss
• History of trauma immediately preceding onset of SSNHL
• History of syphilitic hearing loss
• History of genetic/hereditary hearing loss
• Skull, facial, or temporal bone anomalies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	methylprednisolone sodium succinate	Four doses of methylprednisolone sodium succinate delivered by injection to the middle ear over 2 weeks
1	prednisone	Nineteen days of oral prednisone

Primary Outcome Measures

Name	Time	Method
Hearing Improvement	2 months	Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average.

Trial Locations

Locations (14)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Michigan Ear Institute; 🇺🇸 Farmington Hills, Michigan, United States

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

University of California San Diego; 🇺🇸 San Diego, California, United States

House Ear Institute; 🇺🇸 Los Angeles, California, United States

Massachusetts Eye & Ear Infirmary; 🇺🇸 Boston, Massachusetts, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

University of Massachusetts Medical School; 🇺🇸 Worcester, Massachusetts, United States

New York Eye and Ear Infirmary; 🇺🇸 New York, New York, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

New York University School of Medicine; 🇺🇸 New York, New York, United States

University of Florida, College of Medicine; 🇺🇸 Gainesville, Florida, United States