Phase 4 Hearing Loss Trial, Recruiting NCT04826237 Sponsor: Northwestern University Condition: Hearing Loss
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Phase 4 Hearing Loss Trial, Recruiting

NCT04826237
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 19 and 80 years old
  • You have been diagnosed with sudden hearing loss in one ear that has no known cause, confirmed through hearing and speech tests and a physical exam
  • You first noticed your hearing loss within the last 14 days and are being seen at the clinic within that time
  • Your hearing loss meets a certain level of severity (a hearing threshold greater than 30 dB across three connected sound frequencies)
  • You speak and understand English very well

Who may not be able to join:

  • You are a child or under 18 years old
  • You are currently pregnant
  • You are currently incarcerated
  • You have had a similar episode of sudden hearing loss before
  • You have certain infections, such as a bacterial infection, Lyme disease, tuberculosis, syphilis, or a fungal infection
  • You have an immune system condition affecting your inner ear
  • You have inflammation or fluid in your middle ear
  • You are taking medications known to damage hearing, such as certain chemotherapy drugs, water pills (loop diuretics), or high-dose aspirin
  • You have had a head injury or lead poisoning
  • You have a genetic condition that affects your hearing
  • You have certain metabolic or neurological conditions, such as MELAS, a history of stroke, Cogan's syndrome, or similar disorders (confirm with trial site)
  • You have certain tumour-related conditions affecting the nervous system (confirm with trial site)
  • You have sarcoidosis (an inflammatory disease affecting organs)
  • You have a condition that causes your blood to be thicker than normal (hyperviscosity syndrome)
  • You have diabetes
  • You have taken statin medications (commonly used for cholesterol) in the last 12 months
  • You have a known allergy or sensitivity to any ingredient in the study medication
  • You had tinnitus (ringing in the ears) before this episode
  • You have had ear surgery in the past, other than having ear tubes placed
  • You have a history of drug or alcohol misuse within the last 2 years
  • You have a psychiatric condition that requires treatment with antipsychotics, antidepressants, sleeping pills, or anti-anxiety medications
  • You have a serious neurological condition such as epilepsy, Parkinson's disease, dementia, Alzheimer's disease, or multiple sclerosis
  • You have taken steroid tablets or pills within the last 30 days
  • You have heart disease or have had mini-strokes (TIAs)
  • You have chronic kidney failure
  • You are living with HIV, or have Hepatitis B or C
  • You currently have an active shingles infection
  • You have abnormalities of the skull, face, or the bones around your ear (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Donna Whitlon, Ph.D., Northwestern University

Phone: 8479229047

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
9 February 2023
Est. completion
1 October 2025

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Pure Tone Audiometry for Hearing Assessment; Change in Speech Discrimination; Change in Tinnitus Score

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov