← Back to Search

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

Select...

I speak and understand English very well.

Select...

I am between 19 and 80 years old.

Select...

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:

Select...

I have taken statins in the past year.

Select...

I have a genetic condition that affects my hearing.

Select...

I currently have shingles.

Select...

I do not have any current infections like bacterial, Lyme disease, tuberculosis, or fungal.

Select...

I have a tumor-related condition like neurofibromatosis II.

Select...

I do not have severe epilepsy, Parkinson's, dementia/Alzheimer's, or multiple sclerosis.

Select...

I have a mitochondrial disorder such as MELAS or Cogan's syndrome.

Select...

I have been diagnosed with hyperviscosity syndrome.

Select...

I have been diagnosed with sarcoidosis.

Select...

I have taken oral steroids in the last 30 days.

Select...

I have heart disease or have had TIAs.

Select...

I have middle ear inflammation or fluid buildup.

Select...

I have had a head injury or lead poisoning.

Select...

I have chronic kidney failure.

Select...

I do not have HIV, Hepatitis B, or Hepatitis C.

Select...

I have had ear surgery, but not just for ear tubes.

Select...

I have an autoimmune disease affecting my ears.

Select...

I have diabetes.

Select...

I am currently being treated for a psychiatric condition with medication.

Select...

I have abnormalities in my skull or face bones.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the initiation and the end of the study (up to 4 months after initial assessment)

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