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Oral Statins for Hearing Loss

Phase 4
Recruiting
Led By Donna Whitlon, Ph.D.
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Excellent English Speaking and Comprehension
Patient older than 18 years and younger than 81 years
Must not have
Use of statins within the last 12 months
Genetic disorders affecting hearing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the initiation and the end of the study, up to 4 months after initial assessment
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trialwill test if adding a statin to standard ISSNHL treatment can improve hearing, speech, and tinnitus. Patients will be monitored to measure results.

Who is the study for?
Adults aged 18-80 with sudden one-sided hearing loss, diagnosed within the first two weeks of symptoms. Participants must have a significant level of hearing loss and be fluent in English. Excluded are those with prior similar events, certain diseases (like diabetes or severe neurological conditions), history of substance abuse, recent steroid use, ear anomalies, or who've taken statins or ototoxic drugs recently.
What is being tested?
The trial is testing if adding an oral statin to standard treatment for sudden sensorineural hearing loss improves outcomes. Standard treatment includes methylprednisolone and intratympanic dexamethasone as salvage therapy. Hearing improvement and tinnitus will be measured.
What are the potential side effects?
Possible side effects include muscle pain, headaches, nausea from statins; weight gain, mood swings from methylprednisolone; and brief pain or dizziness from dexamethasone injections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I speak and understand English very well.
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I am between 19 and 80 years old.
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I was diagnosed with sudden hearing loss in one ear.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have taken statins in the past year.
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I have a genetic condition that affects my hearing.
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I currently have shingles.
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I do not have any current infections like bacterial, Lyme disease, tuberculosis, or fungal.
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I have a tumor-related condition like neurofibromatosis II.
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I do not have severe epilepsy, Parkinson's, dementia/Alzheimer's, or multiple sclerosis.
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I have a mitochondrial disorder such as MELAS or Cogan's syndrome.
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I have been diagnosed with hyperviscosity syndrome.
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I have been diagnosed with sarcoidosis.
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I have taken oral steroids in the last 30 days.
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I have heart disease or have had TIAs.
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I have middle ear inflammation or fluid buildup.
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I have had a head injury or lead poisoning.
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I have chronic kidney failure.
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I do not have HIV, Hepatitis B, or Hepatitis C.
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I have had ear surgery, but not just for ear tubes.
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I have an autoimmune disease affecting my ears.
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I have diabetes.
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I am currently being treated for a psychiatric condition with medication.
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I have abnormalities in my skull or face bones.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the initiation and the end of the study (up to 4 months after initial assessment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the initiation and the end of the study (up to 4 months after initial assessment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Pure Tone Audiometry for Hearing Assessment
Change in Speech Discrimination
Body Weight Changes

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: StatinExperimental Treatment3 Interventions
Methylprednisolone+statin (identity and dose to be determined before Trial Begins) Oral methyprednisolone, tapering dose over 11 days, beginning at 16 mg 4 x a day; Oral statin 1 dose per day for 7 days, beginning with the first dose of methylprednisolone: If no improvement after two weeks, offer up to 2 doses intratympanic dexamethasone (10 mg/cc) 10 days apart.
Group II: PlaceboPlacebo Group3 Interventions
Methylprednisolone+ placebo. Oral methyprednisolone, tapering dose over 11 days, beginning at 16 mg 4 x a day; Oral placebo 1 dose per day for 7 days, beginning with the first dose of methylprednisolone If no improvement after two weeks, offer up to 2 doses intratympanic dexamethasone (10 mg/cc) 10 days apart.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
dexamethasone
1995
Completed Phase 3
~9520
methylprednisolone
2004
Completed Phase 4
~1070
Statin
2011
Completed Phase 4
~110100

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,638 Previous Clinical Trials
957,393 Total Patients Enrolled
Donna Whitlon, Ph.D.Principal InvestigatorNorthwestern University

Media Library

dexamethasone Clinical Trial Eligibility Overview. Trial Name: NCT04826237 — Phase 4
Sudden Hearing Loss Research Study Groups: Statin, Placebo
Sudden Hearing Loss Clinical Trial 2023: dexamethasone Highlights & Side Effects. Trial Name: NCT04826237 — Phase 4
dexamethasone 2023 Treatment Timeline for Medical Study. Trial Name: NCT04826237 — Phase 4
~37 spots leftby Oct 2025
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