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Compares treatment options for Meniere Disease
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 Methylprednisolon?
Methylprednisolon is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment 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
- Ménière's disease is an inner ear disorder in which patients suffer from attacks of vertigo, tinnitus and hearing loss. To date, it is unclear what the best treatment for this condition is.
- 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
- A potential subject who meets any of the following criteria will be excluded:
- 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.
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.
- A potential subject who meets any of the following criteria will be excluded:
- 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's taking place
- 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 - 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?
Study sites include Leiden, South Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.