Meniere Disease study: Methylprednisolon
Official title The Effecttiveness of Intratympanic Methylprednisolon Injections Compared to Placebo in the Treatment of Vertigo Attacks in Meniere's Disease
ClinicalTrials.gov ID: NCT05851508
What this study is testing
What is Methylprednisolone?
An investigational intratympanic injection being studied for Meniere disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will compare how well methylprednisolone injections work versus placebo in reducing dizziness, ringing in the ears, hearing loss and improving quality of life over one year.
- Who it's for
- Adults who have been diagnosed with Meniere’s disease and experience vertigo attacks.
- What's involved
- Participants will receive either methylprednisolone or a placebo injection into the inner ear, and will have regular check‑ups and tests to track dizziness, tinnitus, hearing and overall well‑being.
- Time commitment
- The trial lasts one year, with scheduled visits and assessments throughout that period.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100. Healthy volunteers may be eligible.
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...
- age \> 18 years at the start of the trial.
- ≥ 4 vertigo attacks over the last 6 months.
- willing to adhere to daily trial medications and the follow-up assessments.
You likely can't join if
- bilateral MD
- 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...
- 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...
- age \> 18 years at the start of the trial.
- ≥ 4 vertigo attacks over the last 6 months.
- willing to adhere to daily trial medications and the follow-up assessments.
- bilateral MD
- 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.
- pregnant women and nursing women.
The study team makes the final eligibility decision.
Where it is enrolling
- Leiden, South Holland, Netherlands
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, but 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, 18 years to 100 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Leiden, South Holland, Netherlands. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.