100 Participants Needed

Oral Statins for Hearing Loss

DW
Overseen ByDonna Whitlon, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Northwestern University
Must be taking: Oral steroids
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

A small clinical trial for idiopathic sudden sensorineural hearing loss (ISSNHL). Will the addition of an oral statin to the standard treatment (oral methylprednesolone and the salvage therapy of intratympanic dexamethasone) improve the treatment outcome for patients with ISSNHL? This study will compare the two treatments and quantitatively evaluate hearing and speech discrimination and have the patients subjectively evaluate tinnitus.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used statins in the last 12 months or have had oral steroid treatment in the last 30 days. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug for hearing loss?

Research shows that dexamethasone, when administered directly into the ear, can help prevent the worsening of hearing loss in conditions like Ménière's disease, with some patients even experiencing improvement. This suggests that steroids like dexamethasone may have potential in treating hearing loss.12345

How is the drug used in the Oral Statins for Hearing Loss trial different from other treatments for hearing loss?

The treatment in the trial uses oral steroids like dexamethasone and methylprednisolone, which are typically used for their anti-inflammatory effects, and this approach is unique because it explores the potential of these drugs to protect hearing by reducing inflammation, unlike traditional treatments that may not focus on inflammation control.14678

Research Team

DW

Donna Whitlon, Ph.D.

Principal Investigator

Northwestern University

Eligibility Criteria

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.

Inclusion Criteria

Your average hearing loss is 30 decibels or more across three specific frequencies.
I speak and understand English very well.
Seen in the clinic within the first 14 days after the onset of symptoms
See 2 more

Exclusion Criteria

You are allergic or sensitive to any parts of the study medication.
I have taken statins in the past year.
I have a genetic condition that affects my hearing.
See 25 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive oral methylprednisolone and either a statin or placebo for 7 days, with potential intratympanic dexamethasone if no improvement after 2 weeks

4 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including hearing tests and tinnitus evaluation

up to 4 months
2 visits (in-person)

Treatment Details

Interventions

  • dexamethasone
  • methylprednisolone
  • Placebo
  • Statin
Trial OverviewThe 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.
Participant Groups
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.

dexamethasone is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Decadron for:
  • Allergic reactions
  • Blood diseases
  • Eye diseases
  • Skin diseases
  • Respiratory diseases
  • Rheumatic diseases
  • Gastrointestinal diseases
🇪🇺
Approved in European Union as Dexamethasone for:
  • Cerebral edema
  • Acute asthma
  • Chronic obstructive pulmonary disease (COPD)
  • Allergic reactions
  • Skin diseases
  • Eye diseases
🇨🇦
Approved in Canada as Dexamethasone for:
  • Allergic reactions
  • Blood diseases
  • Eye diseases
  • Skin diseases
  • Respiratory diseases
  • Rheumatic diseases
🇯🇵
Approved in Japan as Dexamethasone for:
  • Cerebral edema
  • Acute asthma
  • Chronic obstructive pulmonary disease (COPD)
  • Allergic reactions
  • Skin diseases
  • Eye diseases

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

Findings from Research

In a 12-month study of 17 patients with refractory autoimmune hearing loss, low-dose methotrexate (MTX) was found to be well tolerated and led to hearing improvement in 65% of participants.
MTX also showed positive effects on vertigo symptoms, with 5 out of 9 patients with Meniere's disease experiencing improvement, suggesting it may be a beneficial treatment for autoimmune-related hearing issues.
Open trial of methotrexate as treatment for autoimmune hearing loss.Matteson, EL., Fabry, DA., Facer, GW., et al.[2022]
A 68-year-old male patient with inner ear inflammation and chronic sinusitis experienced significant improvement in hearing loss and sinus symptoms after switching from oral steroids to topical betamethasone, highlighting a potential alternative treatment for those with adverse reactions to systemic steroids.
Audiometry results showed a notable recovery in hearing, with improvements from 50 dB to 20 dB in the right ear and from 70 dB to 35 dB in the left ear, suggesting that topical steroid therapy can effectively address inner ear conditions.
Topical ocular drug delivery to inner ear disease and sinusitis.Mimura, T., Funatsu, H., Usui, T., et al.[2014]
In a study of 67 patients with idiopathic sensorineural hearing loss, pulse therapy with intravenous methylprednisolone did not show a significant advantage over traditional oral prednisolone in improving hearing outcomes.
Both treatment methods resulted in similar levels of hearing improvement, indicating that pulse therapy may not be more effective than standard oral prednisolone for this condition.
Pulse steroid therapy in idiopathic sudden sensorineural hearing loss: A randomized controlled clinical trial.Eftekharian, A., Amizadeh, M.[2022]

References

Open trial of methotrexate as treatment for autoimmune hearing loss. [2022]
Topical ocular drug delivery to inner ear disease and sinusitis. [2014]
Pulse steroid therapy in idiopathic sudden sensorineural hearing loss: A randomized controlled clinical trial. [2022]
Biopolymer-released dexamethasone prevents tumor necrosis factor alpha-induced loss of auditory hair cells in vitro: implications toward the development of a drug-eluting cochlear implant electrode array. [2013]
Intratympanically administered steroid for progressive sensorineural hearing loss in Ménière's disease. [2020]
Cochlear implant surgery facilitates intracochlear distribution of perioperative systemic steroids. [2023]
The Clinical Effect of Steroid Therapy on Preserving Residual Hearing after Cochlear Implantation with the Advanced Bionics HiRes Ultra 3D Cochlear Implant System. [2022]
Glucocorticoids inhibit diastrophic dysplasia sulfate transporter activity in otosclerosis by interleukin-6. [2018]