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Treatment of Menière's disease with intratympanic methylprednisolone (PREDMEN trial)
EU CTIS ID: 2023-503340-13-00
What this study is testing
To determine whether intratympanic injection with 62.5 mg/ml methylprednisolon is superior to placebo in reducing the frequency of vertigo attacks in patients diagnosed with unilateral Meniere's disease during one year of follow-up.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Unilateral, definite MD according to the diagnostic criteria derived from the American Academy Otolaryngology Head and Neck Surgery, Classification Committee of the Bárány Society, European Academy of Otology and Neurotology and International Classification of Vestibular Disorders published in 2015.
- Age > 18 years at the start of the trial.
- ≥ 4 vertigo attacks over the last 6 months.
You likely can't join if
- Bilateral Meniere's Disease.
- Severe disability (e.g. neurological, orthopaedic, cardiovascular) or serious concurrent illness that might interfere with treatment or follow-up.
- Active additional neuro-otologic disorders that may mimic MD (e.g. vestibular migraine, recurrent vestibulopathy, phobic postural vertigo, vertebro-basilar TIAs, acoustic neuroma).
- Otitis media with effusion based on tympanogram results.
- History of intratympanic injections with corticosteroid less than 6 months ago.
- History of intratympanic injections with gentamicin or ear surgery for treating MD.
See the full eligibility criteria
- Unilateral, definite MD according to the diagnostic criteria derived from the American Academy Otolaryngology Head and Neck Surgery, Classification Committee of the Bárány Society, European Academy of Otology and Neurotology and International Classification of Vestibular Disorders published in 2015.
- Age > 18 years at the start of the trial.
- ≥ 4 vertigo attacks over the last 6 months.
- Bilateral Meniere's Disease.
- Severe disability (e.g. neurological, orthopaedic, cardiovascular) or serious concurrent illness that might interfere with treatment or follow-up.
- Active additional neuro-otologic disorders that may mimic MD (e.g. vestibular migraine, recurrent vestibulopathy, phobic postural vertigo, vertebro-basilar TIAs, acoustic neuroma).
- Otitis media with effusion based on tympanogram results.
- History of intratympanic injections with corticosteroid less than 6 months ago.
- History of intratympanic injections with gentamicin or ear surgery for treating MD.
- Women of child bearing age not using contraception, pregnant women, nursing women.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.