Phase 3 Hearing Loss Trial, Recruiting NCT05851508 Sponsor: Leiden University Medical Center Condition: Hearing Loss
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Phase 3 Hearing Loss Trial, Recruiting

NCT05851508
Recruiting Phase 3

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 have been diagnosed with Ménière's disease in one ear only, confirmed using specific international medical guidelines (this includes having at least two episodes of vertigo lasting between 20 minutes and 12 hours, a particular type of hearing loss in one ear confirmed by a hearing test, and fluctuating symptoms such as hearing changes, ringing in the ear, or a feeling of fullness in that ear)
  • You are older than 18 years of age at the time the trial begins
  • You have had 4 or more vertigo attacks in the last 6 months
  • You are willing to take daily trial medication and attend all follow-up appointments as required

Who may not be able to join:

  • You have Ménière's disease in both ears
  • You have a serious disability or illness (for example, a neurological, bone/joint, or heart condition) that could interfere with your treatment or appointments
  • You have another active inner ear or balance disorder that could be confused with Ménière's disease, such as vestibular migraine or a benign tumour on the hearing nerve (confirm with trial site)
  • You have a specific type of middle ear fluid build-up, confirmed by an ear pressure test
  • You have had steroid injections into the ear in the last 6 months
  • You have previously had gentamicin injections into the ear or any ear surgery to treat Ménière's disease
  • You are currently pregnant or breastfeeding

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 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +3171 526 9111

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 3
Sponsor
Leiden University Medical Center
Registry
ClinicalTrials.gov
Start date
1 October 2023
Est. completion
1 May 2026

Where this trial is recruiting

🇳🇱 Netherlands

Primary endpoints

Vertigo spells

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: 28 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